Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories, Hand Pendants…
Medline Industries, LP
Updated Aug 14771,127 total units
Potential fire hazard involving the hand control pendant and associated wiring used with affected beds. Pendant or pendant wiring may overh…
Hazard. Potential fire hazard involving the hand control pendant and associated wiring used with affected beds. Pendant or pendant wiring may overheat, potentially leading to smoking, sparking, melting, burning, or fire. Additional products added to 11/26/2025 recall.
Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories MDR107000P BED…
Medline Industries, LP
Updated Aug 14771,127 total units
Potential fire hazard involving the hand control pendant and associated wiring used with affected beds. Pendant or pendant wiring may overh…
Hazard. Potential fire hazard involving the hand control pendant and associated wiring used with affected beds. Pendant or pendant wiring may overheat, potentially leading to smoking, sparking, melting, burning, or fire. Additional products added to 11/26/2025 recall.
Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier m…
Hazard. Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit discoloration, melting, smoke, burning odor, or other signs of localized thermal damage. Device failure may predispose infant to bronchospasm, inspissated secretions, and airway obstruction, as well as inadvertent positive end-expiratory pressure (P…
Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier m…
Hazard. Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit discoloration, melting, smoke, burning odor, or other signs of localized thermal damage. Device failure may predispose infant to bronchospasm, inspissated secretions, and airway obstruction, as well as inadvertent positive end-expiratory pressure (P…
Charger for the Therabody Theragun, G4 PRO massage device, and products which include the…
Therabody
Updated Jun 23584224 units
Charging cradle for the device may overheat while charging the device's removable battery pack, presenting risk of thermal event (fire). Fi…
Hazard. Charging cradle for the device may overheat while charging the device's removable battery pack, presenting risk of thermal event (fire). Firm has received reports alleging the product caught fire and other reports regarding visible smoke, melting, charger burn, burning odor, and overheating.
Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G…
Fresenius Medical Care Holdings
Updated May 121,756,108 units units
Given the increased number of leaks reported by users, it was determined to be the appropriate course of action to notify users of the pote…
Hazard. Given the increased number of leaks reported by users, it was determined to be the appropriate course of action to notify users of the potential for the occurrence of Bicarby luer-lock leaks during manipulation of the frangible and tubing when preparing the product for use for treatment. This issue presents the potential of a slip and fall hazard associated with fluid on the floor.
The affected products bear an incorrect statement on the carton packaging indicating that the product is "Indicated for Extended Wear". How…
Hazard. The affected products bear an incorrect statement on the carton packaging indicating that the product is "Indicated for Extended Wear". However, this product is intended for daily wear, and the extended-wear statement should not have appeared on the affected carton labeling. This product is not approved by the U.S. Food and Drug Administration (FDA) for extended wear use.
RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020117
Steris
Updated Sep 21106758 units units
If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased internal pressure. In some cases, excess va…
Hazard. If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased internal pressure. In some cases, excess vapor or liquid chemistry may escape from the bottle when the cap is twisted during opening, which could result in user exposure if required personal protective equipment (PPE) is not properly used. Such exposure may result in injury to the user or others in clo…
Wrong lead or percutaneous extension selected. Use of an incompatible lead or percutaneous extension will prevent the system from working a…
Hazard. Wrong lead or percutaneous extension selected. Use of an incompatible lead or percutaneous extension will prevent the system from working as intended and may result in delay of surgery or need for surgical replacement of the product.
InterStim Percutaneous Extensions EXT 3560022 ISTM II PERC 3560022 EXT 3560030 ISTM MICRO…
Medtronic Neuromodulation
Updated Sep 856,331 (US); 40,211 (OUS) units
Wrong lead or percutaneous extension selected. Use of an incompatible lead or percutaneous extension will prevent the system from working a…
Hazard. Wrong lead or percutaneous extension selected. Use of an incompatible lead or percutaneous extension will prevent the system from working as intended and may result in delay of surgery or need for surgical replacement of the product.
DxC 500 AU Clinical Chemistry Analyzers: 1. AU w/out ISE, Part No. C63519 2. AU w/ISE…
Beckman Coulter
Updated Sep 2146 US, 170 OUS units
Beckman Coulter has identified a software issue affecting DxC 500 AU Clinical Analyzers when testing plasma samples. Following user configu…
Hazard. Beckman Coulter has identified a software issue affecting DxC 500 AU Clinical Analyzers when testing plasma samples. Following user configuration of a Clinical Chemistry test to use units different from the system default, a subsequent configuration change and activation of the draft configuration in the System Configuration page may cause the analyzer to revert the test units to the system defau…
DxC 500i Clinical Analyzer Modules: 1. DxC 500 AU Module w/ISE, DxC 500i, Part No. C63522…
Beckman Coulter
Updated Sep 2146 US, 170 OUS units
Beckman Coulter has identified a software issue affecting DxC 500i Clinical Analyzers when testing plasma samples. Following user configura…
Hazard. Beckman Coulter has identified a software issue affecting DxC 500i Clinical Analyzers when testing plasma samples. Following user configuration of a Clinical Chemistry test to use units different from the system default, a subsequent configuration change and activation of the draft configuration in the System Configuration page may cause the analyzer to revert the test units to the system default…
Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and ma…
Hazard. Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.
Sterile Passive spheres and biopsy needle kits contain variation in the reflective material which may affect the ability of the navigation …
Hazard. Sterile Passive spheres and biopsy needle kits contain variation in the reflective material which may affect the ability of the navigation system to detect and track the spheres.
SEDIPLAST; Model/Catalog Numbers: S-100 and S-1000;
POLYMED / POLYMED CANCER DIAGNOSTIC PRODUCTS
Updated Aug 25448400 units
During use of an affected tube, the operator may encounter increased resistance when inserting the pipette. The resulting pressure buildup …
Hazard. During use of an affected tube, the operator may encounter increased resistance when inserting the pipette. The resulting pressure buildup may cause the tube cap to detach or be forcibly ejected, potentially resulting in the release of blood and exposure of the operator or surrounding work area to a biological hazard (blood).
Imager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5; M001314011 IMAGER…
Boston Scientific
Updated Aug 24262,686 units
Tip may fracture or detach, leading to device fragments remaining within the patient or migrating through the vasculature. Patient impact m…
Hazard. Tip may fracture or detach, leading to device fragments remaining within the patient or migrating through the vasculature. Patient impact may include prolonged procedure or life-threatening embolism.
CADD Yellow Medication Cassette Reservoir with NRFit connector US Product Codes…
ICU Medical
Updated Aug 20185,688 units units
Reservoirs may exhibit medication leakage at the joint between luer connector and tubing. Issue could result in delay or interruption of th…
Hazard. Reservoirs may exhibit medication leakage at the joint between luer connector and tubing. Issue could result in delay or interruption of therapy, under delivery of medication, exposure to infectious or toxic agents, or air embolus.
Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems be…
Hazard. Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of volatile anesthetic agents, resulting in deeper/lighter anesthetic effects that may result in hypertonia/hypotonia, tachycardia/ bradycardia, elevated intracranial pressure, awareness during anesthesia, oversedation
Travel Air, Product Number: S00055; Phasitron 5, Product Number: P5 used with Instruction…
Percussionaire
Updated Aug 18228,596 units
Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems be…
Hazard. Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of volatile anesthetic agents, resulting in deeper/lighter anesthetic effects that may result in hypertonia/hypotonia, tachycardia/ bradycardia, elevated intracranial pressure, awareness during anesthesia, oversedation
Impulsator, Product Number: S00010, Phasitron 5, Product Number: P5 used with Instruction…
Percussionaire
Updated Aug 18228,277 units
Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems be…
Hazard. Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of volatile anesthetic agents, resulting in deeper/lighter anesthetic effects that may result in hypertonia/hypotonia, tachycardia/ bradycardia, elevated intracranial pressure, awareness during anesthesia, oversedation
Brand Name: Performance Pro Product Name: Performance Pro Model/Catalog Number…
American Nitrile Operations
Updated Aug 1499,724,000 units
Gloves may exhibit defects such as tears, missing fingers, and debris. Use of defective gloves may lead to healthcare personnel and patient…
Hazard. Gloves may exhibit defects such as tears, missing fingers, and debris. Use of defective gloves may lead to healthcare personnel and patient exposure to infectious pathogens leading to infection or cross-contamination, or exposure to chemical agents leading to irritation or systemic toxicities.
Gloves may exhibit defects such as tears, missing fingers, and debris. Use of defective gloves may lead to healthcare personnel and patient…
Hazard. Gloves may exhibit defects such as tears, missing fingers, and debris. Use of defective gloves may lead to healthcare personnel and patient exposure to infectious pathogens leading to infection or cross-contamination, or exposure to chemical agents leading to irritation or systemic toxicities.
The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental cond…
Hazard. The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products with Aspergillus penicillioides may lead to serious adverse health consequences, including systemic infection, sepsis, illness, and death.
The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental cond…
Hazard. The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products with Aspergillus penicillioides may lead to serious adverse health consequences, including systemic infection, sepsis, illness, and death.
Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use, which may resul…
Hazard. Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use, which may result in loss of CPAP pressure, possibly reducing the effectiveness of treatment and lead to decreased oxygenation until connection is restored.
Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use, which may resul…
Hazard. Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use, which may result in loss of CPAP pressure, possibly reducing the effectiveness of treatment and lead to decreased oxygenation until connection is restored.
Capsule may fail to attach to the esophagus or detach from the delivery device. Risks include patient aspiration/inhalation, perforation of…
Hazard. Capsule may fail to attach to the esophagus or detach from the delivery device. Risks include patient aspiration/inhalation, perforation of esophagus, obstruction of the airway, hemorrhage/blood loss/bleeding, laceration of the esophagus, a delay in diagnosis, and foreign bodies remaining in the patient.
HEALON EndoCoat PRO, REF: 10300012 (US/CAN) HEALON DUET PRO II, REF: 10300016 (US/CAN)…
Johnson & Johnson Surgical Vision
Updated Jul 31111,478 units
Surgical instructions sent for viscoelastic products used during ophthalmic viscosurgical cataract procedures including in part: If resista…
Hazard. Surgical instructions sent for viscoelastic products used during ophthalmic viscosurgical cataract procedures including in part: If resistance is encountered during insertion, withdraw cannula and reassess the insertion conditions (i.e. insertion angle, incision size, etc.) before proceeding because forcing the cannula may cause corneal abrasion, iris trauma or descemet's membrane detachment.
Carescape Central Station CSCS V3 MAS800 Desktop Part Number 5867474-04, 5867474-13…
GE Medical Systems Information Technologies
Updated Jul 3029,570 (23,632 US; 5,938 OUS) units
Device may not resume patient monitoring for at least 3 minutes following system restart. Issue can lead to potential delay in recognition …
Hazard. Device may not resume patient monitoring for at least 3 minutes following system restart. Issue can lead to potential delay in recognition of clinically significant events.
Lot B26043FM may include EDTA contamination which introduces potassium while chelating calcium in patient samples, leading to falsely eleva…
Hazard. Lot B26043FM may include EDTA contamination which introduces potassium while chelating calcium in patient samples, leading to falsely elevated potassium (K+) and falsely decreased calcium (Ca++) results which have the potential to cause hyperkalemia.
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators PAIN PRE OP KIT…
Medline Industries, LP
Updated Jul 20222,653 total units
Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may h…
Hazard. Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the applicator packaging. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.
Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may h…
Hazard. Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the applicator packaging. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.
Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may h…
Hazard. Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the applicator packaging. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.
Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may h…
Hazard. Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the applicator packaging. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.
Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may h…
Hazard. Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the applicator packaging. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.
Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may h…
Hazard. Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the applicator packaging. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.
Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may h…
Hazard. Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the applicator packaging. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.
Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may h…
Hazard. Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the applicator packaging. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.
Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may h…
Hazard. Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the applicator packaging. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.
Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may h…
Hazard. Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the applicator packaging. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.
Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may h…
Hazard. Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the applicator packaging. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.
Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may h…
Hazard. Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the applicator packaging. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.
Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may h…
Hazard. Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the applicator packaging. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.
Firm has identified mismatches between the outbreak strain and the reference strain used in the development of its qualitative, multiplexed…
Hazard. Firm has identified mismatches between the outbreak strain and the reference strain used in the development of its qualitative, multiplexed, nucleic acid-based in vitro diagnostic panel test.
Hollister has identified that select lots of the catheters identified in the above table may exhibit a protrusion caused by a manufacturing…
Hazard. Hollister has identified that select lots of the catheters identified in the above table may exhibit a protrusion caused by a manufacturing defect which might lead to genitourinary trauma or bleeding.
OBP Medical , ER-Spec Single-Use Vaginal Speculum with LED Light Source, X-Small REF…
OBP Medical
Updated Jul 138,224 boxes (148,032 units) units
There is a potential for vaginal speculums to contain a burr on the proximal plastic blade, which may introduce a sharp edge in the contact…
Hazard. There is a potential for vaginal speculums to contain a burr on the proximal plastic blade, which may introduce a sharp edge in the contact regions for both the patient and the healthcare provider.
Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to th…
Hazard. Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life. Reduced bleach concentration may compromise the effectiveness of disinfection, potentially allowing for the survival and persistence of pathogenic microorganisms.
Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to th…
Hazard. Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life. Reduced bleach concentration may compromise the effectiveness of disinfection, potentially allowing for the survival and persistence of pathogenic microorganisms.
Devices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There is a risk of syringe loosening or disconne…
Hazard. Devices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There is a risk of syringe loosening or disconnecting from the manifold, resulting in loose connection or complete disconnection. May lead to difficulty connecting syringe, inability to aspirate or inject properly, fluid leakage, or separation of the syringe from the system, potentially requiring device exc…
out-of-specification sodium azide concentration in Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls Lot U2. While the assay…
Hazard. out-of-specification sodium azide concentration in Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls Lot U2. While the assay results were not impacted, the overall health risk to lab technicians due to this issue is low, as exposure is limited by small volumes and a 0.2% post-reconstitution sodium azide concentration, with the worst outcome being mild skin or eye irritation and no …
Products that contain the Pericare Wipes: Bard¿ Foley Tray With Lubri-Sil¿ All-Silicone…
C.R. Bard
Updated Jun 25283883 trays/kits units
Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermitte…
Hazard. Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
Products that contain the Pericare Wipes: *Bardex¿ I.C. Complete Care¿ Foley Catheter…
C.R. Bard
Updated Jun 25212580 units
Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermitte…
Hazard. Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
Products that contain the Pericare Wipes: SureStep Intermittent Catheter Tray REF: INTP16…
C.R. Bard
Updated Jun 25391720 units/kits units
Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermitte…
Hazard. Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides…
ResMed
Updated Jun 25168,069 devices globally units
Due to a Supercapacitor electrolyte leakage on Printed Circuit Board Assembly (PCBA) may damage the charger chip, causing fail-safe state a…
Hazard. Due to a Supercapacitor electrolyte leakage on Printed Circuit Board Assembly (PCBA) may damage the charger chip, causing fail-safe state and interruption of ventilation therapy.
V-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS KING BOX06614V4 BOX BY…
Covidien, LP
Updated Jun 24135,875 total units
Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile suture…
Hazard. Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.
Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile suture…
Hazard. Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.
Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile suture…
Hazard. Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.
Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile suture…
Hazard. Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.
Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX
Covidien, LP
Updated Jun 24135,875 total units
Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile suture…
Hazard. Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.
Events observed where anesthetic agent was not delivered when the vaporizer was activated. Failure to deliver the anesthetic agent may resu…
Hazard. Events observed where anesthetic agent was not delivered when the vaporizer was activated. Failure to deliver the anesthetic agent may result in the patient receiving insufficient anesthesia and may lead to intraoperative awareness.
The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging,…
Hazard. The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less com…
The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging,…
Hazard. The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less com…
FARADRIVE STEERABLE SHEATH (CLEAR) - US, used to facilitate access to the vasculature and…
Boston Scientific
Updated Jun 11508,151 units units
Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve d…
Hazard. Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve damage may result in air ingress, potential air embolism, and associated patient harm. This risk can be mitigated by inserting the dilator straight through the center of the valve …
FARADRIVE STEERABLE SHEATH CLEAR OUS, used to facilitate access to the vasculature and…
Boston Scientific
Updated Jun 11193,000 units units
Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve d…
Hazard. Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve damage may result in air ingress, potential air embolism, and associated patient harm. This risk can be mitigated by inserting the dilator straight through the center of the valve …
Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA III…
Olympus of the Americas
Updated Jun 5988700 units units
Olympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous design of the Single Use Dista…
Hazard. Olympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous design of the Single Use Distal Covers.
Due to stopcock issues when using the plastic luer-lok syringe, the connection at the Port C may over thread or continue to spin rather tha…
Hazard. Due to stopcock issues when using the plastic luer-lok syringe, the connection at the Port C may over thread or continue to spin rather than tightening securely. This behavior has led some clinical users to perceive the connection as unstable.
Omnipod 5 Pods. Includes the below Model/REF Numbers: 1. POD-OMNI-I1-6720. 2…
Insulet
Updated May 204,936,056 units units
External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user reg…
Hazard. External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus delivery. The primary failure mode is pump under-delivery due to loss of insulin to an external leak. If insulin is not delivered properly, users may experience high blood glucose levels due to under-delivery of insulin. In the most s…
Omnipod DASH Pod. Includes the below Model/REF Numbers: 1. POD-BLE-I1-525 (5-Pack)…
Insulet
Updated May 201,790,784 units units
External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user reg…
Hazard. External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus delivery. The primary failure mode is pump under-delivery due to loss of insulin to an external leak. If insulin is not delivered properly, users may experience high blood glucose levels due to under-delivery of insulin. In the most s…
Omnipod (Eros) Pod. Includes the below Model/REF Numbers: 1. POD-ZXP425 (10 Pack), POD…
Insulet
Updated May 20289,046 units units
External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user reg…
Hazard. External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus delivery. The primary failure mode is pump under-delivery due to loss of insulin to an external leak. If insulin is not delivered properly, users may experience high blood glucose levels due to under-delivery of insulin. In the most s…
Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolor…
Hazard. Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The presence of discoloration and particulate matter in the fluid path has not been ruled out.
Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolor…
Hazard. Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The presence of discoloration and particulate matter in the fluid path has not been ruled out.
Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolor…
Hazard. Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The presence of discoloration and particulate matter in the fluid path has not been ruled out.
Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolor…
Hazard. Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall that does not enter the fluid path, which if seen by a healthcare provider may lead to replacement of product before use, which could result in a delay in therapy.
Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolor…
Hazard. Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The presence of discoloration and particulate matter in the fluid path has not been ruled out.
5008X Blood Tubing Set, 24 units per case. Includes the below model numbers and…
Fresenius Medical Care Holdings
Updated May 11113,544 units (4,731 cases) units
Potential for Online Port Errors due to connection issues when connecting the SafeLine of the 5008X CAREset to the substitution fluid port …
Hazard. Potential for Online Port Errors due to connection issues when connecting the SafeLine of the 5008X CAREset to the substitution fluid port of the 5008X CAREsystem.
Panda Freestanding Warmer, Infant Radiant Warmer Product Identifiers: 2063568-001…
Datex-Ohmeda
Updated May 8550 (367 US; 183 OUS) units
Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that doe…
Hazard. Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the intended concentration set by the user, potentially resulting in hypoxia or hyperoxia in the patient.
Giraffe Warmer with Integrated Resuscitation System (iRes), Panda Warmer with Integrated…
Datex-Ohmeda
Updated May 8550 (367 US; 183 OUS) units
Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that doe…
Hazard. Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the intended concentration set by the user, potentially resulting in hypoxia or hyperoxia in the patient.
Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that doe…
Hazard. Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the intended concentration set by the user, potentially resulting in hypoxia or hyperoxia in the patient.
The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental cond…
Hazard. The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products with Aspergillus penicillioides may lead to serious adverse health consequences, including systemic infection, sepsis, illness, and death.
The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental cond…
Hazard. The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products with Aspergillus penicillioides may lead to serious adverse health consequences, including systemic infection, sepsis, illness, and death.
Ultrasound system may: 1) Not recognize previous transducer registration, prevent scanning, require re-registration with Wi-Fi/cellular acc…
Hazard. Ultrasound system may: 1) Not recognize previous transducer registration, prevent scanning, require re-registration with Wi-Fi/cellular access, which may be unavailable outside of the hospital (ambulances/aircraft/field); 2) At connection between transducer USB cable to tablet/phone, there may be an unstable connection/may disconnect disrupting function. May cause diagnosis/treatment delay.
RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020116
Steris
Updated Sep 2111806 units units
If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased internal pressure. In some cases, excess va…
Hazard. If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased internal pressure. In some cases, excess vapor or liquid chemistry may escape from the bottle when the cap is twisted during opening, which could result in user exposure if required personal protective equipment (PPE) is not properly used. Such exposure may result in injury to the user or others in clo…
V*Home, Model Number: PRT-01444-000, Package PN:PRT-01445-000. used for ventilatory…
Ventec Life Systems
Updated Sep 1725,112 units units
Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interr…
Hazard. Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.
V+Pro Model Number: PRT-01185-000, Package PN:PRT-01198-000; Model Number: PRT-01185-001…
Ventec Life Systems
Updated Sep 1739,568 units units
Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interr…
Hazard. Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.
V+ Pro Emergency, Model Number: PRT-01201-000, Package PN:PRT-01173-000,PRT-01222-000…
Ventec Life Systems
Updated Sep 1730,120 units units
Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interr…
Hazard. Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.
Medline surgical convenience kits labeled as: 1) OPEN HEART PACK A & B, Medline…
Medline Industries, LP
Updated Sep 236199 kits units
Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and ma…
Hazard. Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.
Compression bandage may be degraded, which may cause unwanted foreign material to be introduced inside the wound, which may lead to wound e…
Hazard. Compression bandage may be degraded, which may cause unwanted foreign material to be introduced inside the wound, which may lead to wound exploration and irrigation, formation of scar tissue, and infection.
Sterile Passive spheres and biopsy needle kits contain variation in the reflective material which may affect the ability of the navigation …
Hazard. Sterile Passive spheres and biopsy needle kits contain variation in the reflective material which may affect the ability of the navigation system to detect and track the spheres.
Sterile Passive spheres and biopsy needle kits contain variation in the reflective material which may affect the ability of the navigation …
Hazard. Sterile Passive spheres and biopsy needle kits contain variation in the reflective material which may affect the ability of the navigation system to detect and track the spheres.
BeneVision Series Telemetry Monitor. Operator's Manuals: TM70/TM80
Mindray DS USA
Updated Aug 3129,737 units units
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiologi…
Hazard. Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
Panorama and Telemetry Monitoring System. Operator's Manuals: TMS-6016/Panorama…
Mindray DS USA
Updated Aug 3111,831 units units
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiologi…
Hazard. Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
BeneVision N1 and N-Series Patient Monitor. Patient Monitor: N12/N15/N17/N19/N22.
Mindray DS USA
Updated Aug 3144,651 units units
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiologi…
Hazard. Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiologi…
Hazard. Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Number: S3060
Steris
Updated Aug 311185 units
Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor …
Hazard. Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator will show no growth, indicating that the steam cycle was effective, even if the steam cycle did not achieve the intended spore reduction
VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Number: S3061
Steris
Updated Aug 312205 units
Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor …
Hazard. Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator will show no growth, indicating that the steam cycle was effective, even if the steam cycle did not achieve the intended spore reduction
Passport Series Patient Monitor. Operator's Manuals: 8 / 12 / 12M / 17M / V
Mindray DS USA
Updated Aug 3139,891 units units
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiologi…
Hazard. Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 18" X 4" 2-Line, Red…
ASP Global
Updated Aug 2455050 units
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 34" X 4" 1-Line, Blue…
ASP Global
Updated Aug 2453040 units
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 12" X 3.5" 2-Line, Plum…
ASP Global
Updated Aug 2410060 units
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 34" X 4" 2-Line, Blue…
ASP Global
Updated Aug 2465640 units
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 30" X 4" 2-Line, White…
ASP Global
Updated Aug 2445960 units
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 18" X 4" 1-Line, Red…
ASP Global
Updated Aug 2436680 units
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 30" X 4" 1-Line, White…
ASP Global
Updated Aug 2434550 units
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems be…
Hazard. Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of volatile anesthetic agents, resulting in deeper/lighter anesthetic effects that may result in hypertonia/hypotonia, tachycardia/ bradycardia, elevated intracranial pressure, awareness during anesthesia, oversedation
The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage fr…
Hazard. The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand piece that can pool on the floor. The impact can range from user dissatisfaction to the potential for the user of slip and fall.
Rollator, Bariatric, Basic Steel, Burgundy, mechanical walker with four legs and a metal…
Medline Industries, LP
Updated Aug 141824 units units
The front fork stem bolt/wheel assembly may disconnect from the rollator frame tubing. If the front fork stem bolt/wheel assembly disconnec…
Hazard. The front fork stem bolt/wheel assembly may disconnect from the rollator frame tubing. If the front fork stem bolt/wheel assembly disconnects from the rollator frame tubing, the front wheels may become loose or detach from the rollator. If the front wheels become loose or detach during use, there is risk of severe adverse events. The immediate consequences could include falls resulting in head tr…
Medline Convenience Kits: 1) OPEN HEART ADULT, Catalog Number: CDS840396Y; 2) FULL LINE…
Medline Industries, LP
Updated Aug 11489 kits units
The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental cond…
Hazard. The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products with Aspergillus penicillioides may lead to serious adverse health consequences, including systemic infection, sepsis, illness, and death.
The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental cond…
Hazard. The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products with Aspergillus penicillioides may lead to serious adverse health consequences, including systemic infection, sepsis, illness, and death.
Medline Convenience Kits: 1) PORT ACCESS KIT UNIV OF ALA, Catalog Number: DYKM1414; 2)…
Medline Industries, LP
Updated Aug 11447 kits units
The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental cond…
Hazard. The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products with Aspergillus penicillioides may lead to serious adverse health consequences, including systemic infection, sepsis, illness, and death.
Baxter Novum IQ Syringe Pump, Model Number 40800BAXUS
Baxter Healthcare
Updated Aug 1114601 units units
A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty and is replaced while a Volu…
Hazard. A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty and is replaced while a Volume To Be Infused (VTBI) remains.
Presource Convenience Kits: 1) KIT, PRE OP , Catalog Number: AMN548616A; 2) KIT, NICU…
Cardinal Health 200
Updated Aug 1017503 kits units
The kits contain applicators that may exhibit an open or incomplete seal on the packaging of the applicator. Use of a potentially contamina…
Hazard. The kits contain applicators that may exhibit an open or incomplete seal on the packaging of the applicator. Use of a potentially contaminated applicator could result in no patient harm or may lead to localized skin or soft tissue infection. Less commonly, systemic infection or other infectious complications may occur.
5008X HD/HDF with CLiC Blood Tubing Set Part number 03-5300-3C
Fresenius Medical Care Renal Therapies Group
Updated Aug 1018,600 units
Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during tre…
Hazard. Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia.
5008X HD/HDF Standard Blood Tubing Set Part Number 03-5300-3
Fresenius Medical Care Renal Therapies Group
Updated Aug 1062,544 units units
Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during tre…
Hazard. Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia.
Product Name: DermaV Laser System Model/Catalog Number: DermaV Medical laser device that…
Lutronic
Updated Aug 61065 units
Utilizing higher fluences at 1064nm wavelength with current cryogen parameters may result in a spark/loud noise during treatment, potential…
Hazard. Utilizing higher fluences at 1064nm wavelength with current cryogen parameters may result in a spark/loud noise during treatment, potentially resulting in patient burn.
Certain AU480 chemistry analyzers, with Windows 10 IoT Enterprise 2021 LTSC PCs, may output the message System Stopped By Fatal Error: DBCo…
Hazard. Certain AU480 chemistry analyzers, with Windows 10 IoT Enterprise 2021 LTSC PCs, may output the message System Stopped By Fatal Error: DBConnectionError AlarmDB when launching the instrument software, using PC pre-installed with Microsoft SQL Server 2022 Express. When this occurs, AlarmDB becomes unreadable and the instrument software cannot be started. This causes a delay in obtaining patient re…
Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Produc…
Hazard. Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and infla…
OMNIFIT SERIES I ACET. INSERT 10¿ 22mm ID Catalog No. 2001-2246 Orthopaedic implant…
Howmedica Osteonics
Updated Jul 3012,156 US units
Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Produc…
Hazard. Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and infla…
ACETABULAR CUP UHMWPE 61-3258 ALL POLY CONSTRAINED INSERT 44MM 69-2244 ALL POLY…
Howmedica Osteonics
Updated Jul 3012,156 US units
Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Produc…
Hazard. Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and infla…
ABG I ACETABULAR INSERT HOODED 28mm ID X 48mm C-M079-2-801 ARC2F ACETABULAR INSERT…
Howmedica Osteonics
Updated Jul 3012,156 US units
Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Produc…
Hazard. Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and infla…
Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Produc…
Hazard. Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and infla…
Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Produc…
Hazard. Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and infla…
TRIATHLON HINGE INSERT SIZE 4 11MM 5612-P-411 TRIATHLON HINGE INSERT SIZE 4 13MM…
Howmedica Osteonics
Updated Jul 3012,156 US units
Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Produc…
Hazard. Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and infla…
SCORPIO RECESSED METAL BACKED PATELLA 3045-0026 3045-0028 3045-0030 3045-0032 Orthopaedic…
Howmedica Osteonics
Updated Jul 3012,156 US units
Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Produc…
Hazard. Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and infla…
BEARING AND AXLE BUSHING ASSY STD ELBOW C-M113-1-301 KRH REV TIB INS 16mm THK .640 DIA…
Howmedica Osteonics
Updated Jul 3012,156 US units
Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Produc…
Hazard. Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and infla…
SCORPIO + MOBILE BEARING PCS 78-5-0910 SYSTEM ONE BIPOLAR 40MM 6074-4022 SYSTEM ONE…
Howmedica Osteonics
Updated Jul 3012,156 US units
Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Produc…
Hazard. Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and infla…
Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Produc…
Hazard. Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and infla…
Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Produc…
Hazard. Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and infla…
BD Needle Kit for Powered Driver 15mm x 15Ga, REF: D015151NK, BD Needle Kit for Powered…
Bard Access Systems
Updated Jul 3080,200 units
After placement of intraosseous (IO) needle sets, used when intravenous access is difficult or impossible to obtain in emergent, urgent, or…
Hazard. After placement of intraosseous (IO) needle sets, used when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases, users may experience difficulty/inability to remove obturator, due to it locking to the needle hub, due to out-of-tolerance dimensions and IFU unclarity, which may result in new needle placement, which may result in delayed therapy
StatStrip Glucose Hospital Meter System. Model No: 63685. Glucose test system.
Nova Biomedical
Updated Jul 2920,616 units units
A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermitten…
Hazard. A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previously scanned barcode including patient identification (ID) barcodes and quality control (QC) solution ID barcodes when a new barcode is scanned, resulting in the prior barcode information remaining displayed on the screen for the current tes…
StatStrip Glucose Hospital Meter System. Model No: 66739. Glucose test system.
Nova Biomedical
Updated Jul 2910,941 units units
A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermitten…
Hazard. A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previously scanned barcode including patient identification (ID) barcodes and quality control (QC) solution ID barcodes when a new barcode is scanned, resulting in the prior barcode information remaining displayed on the screen for the current tes…
The issue is related to card pouch damage associated with a portion of the lot which was produced on a specific card pouching device, in a …
Hazard. The issue is related to card pouch damage associated with a portion of the lot which was produced on a specific card pouching device, in a specific timeframe, causing a potential risk of false resistant results. False resistant results may lead to the use of less effective antibiotic treatments or the association of multiple antibiotics having negative side effects, which could potentially impact…
Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1 mL…
AVID Medical
Updated Jul 22816 kits (17 cases) units
Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may exhibit an open or incomplete seal on the packaging of the app…
Hazard. Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may exhibit an open or incomplete seal on the packaging of the applicator.
Two software related issues affecting Azurion R2.2.10 Systems: 1) Potential image quality degradation that may lead to delay of therapy, pr…
Hazard. Two software related issues affecting Azurion R2.2.10 Systems: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment and 2) Potential loss of geometry movements that may lead to delay of therapy and procedural complications
Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to th…
Hazard. Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life. Reduced bleach concentration may compromise the effectiveness of disinfection, potentially allowing for the survival and persistence of pathogenic microorganisms.
Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507; Solution…
Baxter Healthcare
Updated Jun 3024528 units units
Baxter received customer reports of air bubbles in the drip chamber and tubing when a pressure cuff is in use or when the tubing is flushed…
Hazard. Baxter received customer reports of air bubbles in the drip chamber and tubing when a pressure cuff is in use or when the tubing is flushed at the fully open position.
ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000
Erbe USA
Updated Jun 2611226 units units
A strong pull on the high-pressure transfer hose of cryosurgical unit may lead to pneumatic short circuit between he gas inlet and the conn…
Hazard. A strong pull on the high-pressure transfer hose of cryosurgical unit may lead to pneumatic short circuit between he gas inlet and the connector resulting in CO2 leaking into the return path, leading to excessive pressure causing the cryoprobe to rupture.
Products that contain the Pericare Wipes: Bardex Lubricath Foley Catheter Tray REF…
C.R. Bard
Updated Jun 2512,463 trays/kits units
Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermitte…
Hazard. Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
Products that contain the Pericare Wipes: SureStep" Foley Tray System Add-A-Foley…
C.R. Bard
Updated Jun 2533850 units/kits units
Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermitte…
Hazard. Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this…
Hazard. If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.
If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this…
Hazard. If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.
If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this…
Hazard. If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.
If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this…
Hazard. If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.
If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this…
Hazard. If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.
If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this…
Hazard. If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.
If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this…
Hazard. If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.
If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this…
Hazard. If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.
If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this…
Hazard. If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.
If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this…
Hazard. If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.
If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this…
Hazard. If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.
If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this…
Hazard. If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.
If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this…
Hazard. If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.
Hotline Fluid Warming Set, single use device, is designed to warm blood and intravenous…
ICU Medical
Updated Jun 2439,750 units units
ICU Medical became aware of an increased likelihood of leakage in specific Lots of L-70 HOTLINE Fluid Warming Sets due to potentially inade…
Hazard. ICU Medical became aware of an increased likelihood of leakage in specific Lots of L-70 HOTLINE Fluid Warming Sets due to potentially inadequate solvent application at the tubing to return connector bond.
EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with…
Medtronic Perfusion Systems
Updated Jun 2411,720 units units
Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hy…
Hazard. Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration or perforation, hypotension, ischemia, and organ dysfunction.
EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with…
Medtronic Perfusion Systems
Updated Jun 2413,510 units units
Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hy…
Hazard. Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration or perforation, hypotension, ischemia, and organ dysfunction.
EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with…
Medtronic Perfusion Systems
Updated Jun 2421,290 units units
Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hy…
Hazard. Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration or perforation, hypotension, ischemia, and organ dysfunction.
The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging,…
Hazard. The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less com…
Medline Convenience Kits: 1) PRE-OP KIT, Catalog Number: DYKS1043F; 2) PRE OP KIT…
Medline Industries, LP
Updated Jun 1213032 kits units
The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging,…
Hazard. The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less com…
The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging,…
Hazard. The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less com…
Medline Convenience Kits: 1) IV START KIT LAB DRAW-SH, Model Number: CDS860014P; 2) IV…
Medline Industries, LP
Updated Jun 1222736 Kits units
The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging,…
Hazard. The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less com…
The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging,…
Hazard. The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less com…
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers.…
Hazard. A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into…
Boston Scientific
Updated Jun 1174,760 units units
Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve d…
Hazard. Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve damage may result in air ingress, potential air embolism, and associated patient harm. This risk can be mitigated by inserting the dilator straight through the center of the valve …
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers.…
Hazard. A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) Item Number…
ICU Medical
Updated Jun 1012525 units units
In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to …
Hazard. In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.
Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, …
Hazard. Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region.
Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior…
Hazard. Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find another readily available device.
Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior…
Hazard. Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find another readily available device.
Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.
Siemens Healthcare Diagnostics
Updated Jun 824,077 units units
The potential for intermittent well-to-well bias on the A1c_E assay on the Atellica CH and Atellica CI analyzer which could cause falsely d…
Hazard. The potential for intermittent well-to-well bias on the A1c_E assay on the Atellica CH and Atellica CI analyzer which could cause falsely depressed or falsely elevated HbA1c patient results.
May contain incorrect connectors and will not attach or misconnect to ENFit connections and is thus incompatible. Issue could lead to sligh…
Hazard. May contain incorrect connectors and will not attach or misconnect to ENFit connections and is thus incompatible. Issue could lead to slight delay in delivery of enteral nutritional fluids or oral medication.
VITEK 2 AST-N447 TEST KIT Product reference 424620
Biomerieux
Updated Jun 445,900 cards units
Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch fo…
Hazard. Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures.
Ventilator coaxial breathing circuit may have, expiratory valve sets with membranes sticking to valve body, not detectable during pre-opera…
Hazard. Ventilator coaxial breathing circuit may have, expiratory valve sets with membranes sticking to valve body, not detectable during pre-operative test, which will result in "exhalation obstructed " alarm, which may result in inadequate ventilation, oxygen desaturation. Advising: Prior to use, test lung action. If alarm occurs, expiratory valve set removal to overcome membrane adhesion or replacement
Hillrom VOLARA System P.CIRCUIT KIT AC (Single Patient Use Circuit), Model/Catalog Number…
Baxter Healthcare
Updated May 2116187 units units
There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage …
Hazard. There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the delivery of the prescribed treatment. The issue has been associated with improper locking of the nebulizer cup after adding medication during user setup.
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently bein…
Hazard. Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently bein…
Hazard. Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Medline Convenience Kits: 1) PI CVC KIT 3L 7 FR 16 CM, Model Number: ECVC8520; 2) NO CATH…
Medline Industries, LP
Updated May 2148075 kits units
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons …
Hazard. The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently bein…
Hazard. Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons …
Hazard. The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently bein…
Hazard. Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently bein…
Hazard. Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Hillrom VOLARA System P.CIRCUIT 5KIT AC, (Single Patient Use Circuit), Model/Catalog…
Baxter Healthcare
Updated May 2113881 units units
There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage …
Hazard. There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the delivery of the prescribed treatment. The issue has been associated with improper locking of the nebulizer cup after adding medication during user setup.
Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catalog Number…
Baxter Healthcare
Updated May 2110540 units units
There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage …
Hazard. There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the delivery of the prescribed treatment. The issue has been associated with improper locking of the nebulizer cup after adding medication during user setup.
The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological S…
Hazard. The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products.
Halyard medical convenience kits labeled as: 1) ENT, Model/Item Number (kit) ACEN89-01…
AVID Medical
Updated May 1911763 kits units
The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological S…
Hazard. The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products.
Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolor…
Hazard. Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall that does not enter the fluid path, which if seen by a healthcare provider may lead to replacement of product before use, which could result in a delay in therapy.
Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolor…
Hazard. Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The presence of discoloration and particulate matter in the fluid path has not been ruled out.
Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software
Abbott Medical
Updated May 1211182 programs units
Software malfunction may occur during pacing capture threshold test of pacemaker resulting in programmer not successfully communicating the…
Hazard. Software malfunction may occur during pacing capture threshold test of pacemaker resulting in programmer not successfully communicating the command to terminate the test.
Potential issue involving motor shaft breakage combined with reduced performance of the Single Fault Safety (SFS) system may lead to instan…
Hazard. Potential issue involving motor shaft breakage combined with reduced performance of the Single Fault Safety (SFS) system may lead to instances where the lift strap lowers more quickly than expected during use. Patients are at some risk for injury if a significant fall/drop were to occur due to this issue.
VERIFY Biological Steam Test Pack Model/Catalog Number: S3069
Steris
Updated Aug 31233 units
Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor …
Hazard. Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator will show no growth, indicating that the steam cycle was effective, even if the steam cycle did not achieve the intended spore reduction
Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor …
Hazard. Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator will show no growth, indicating that the steam cycle was effective, even if the steam cycle did not achieve the intended spore reduction
Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor …
Hazard. Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator will show no growth, indicating that the steam cycle was effective, even if the steam cycle did not achieve the intended spore reduction
VERIFY Biological Steam Test Pack Model/Catalog Number: S3065
Steris
Updated Aug 31217 units
Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor …
Hazard. Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator will show no growth, indicating that the steam cycle was effective, even if the steam cycle did not achieve the intended spore reduction
The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage fr…
Hazard. The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand piece that can pool on the floor. The impact can range from user dissatisfaction to the potential for the user of slip and fall.
The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage fr…
Hazard. The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand piece that can pool on the floor. The impact can range from user dissatisfaction to the potential for the user of slip and fall.
Rollator, Bariatric, Basic Steel, Blue, mechanical walker with four legs and a metal…
Medline Industries, LP
Updated Aug 14835 units units
The front fork stem bolt/wheel assembly may disconnect from the rollator frame tubing. If the front fork stem bolt/wheel assembly disconnec…
Hazard. The front fork stem bolt/wheel assembly may disconnect from the rollator frame tubing. If the front fork stem bolt/wheel assembly disconnects from the rollator frame tubing, the front wheels may become loose or detach from the rollator. If the front wheels become loose or detach during use, there is risk of severe adverse events. The immediate consequences could include falls resulting in head tr…
Subrecall of a kitted device from SafeGuard Medical due to internal testing identified an issue affecting the device's sterile pad, potenti…
Hazard. Subrecall of a kitted device from SafeGuard Medical due to internal testing identified an issue affecting the device's sterile pad, potentially causing the sterile pad to degrade over time. The degradation may cause remnants of the nonwoven pad material to dislodge on the wound or in close proximity to the wound.
VOCSN+Pro, Model Number:PRT-00490-001, Package PN:PRT-00853-000. used for ventilatory…
Ventec Life Systems
Updated Sep 174,369 units units
Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interr…
Hazard. Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.
VC+Pro Model Number: PRT-00900-001, Package PN:PRT-00973-000. used for ventilatory…
Ventec Life Systems
Updated Sep 171,534 units units
Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interr…
Hazard. Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.
VOCSN Model Number: PRT-01100-000, Package PN:PRT-01126-000. used for ventilatory support.
Ventec Life Systems
Updated Sep 171,532 units units
Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interr…
Hazard. Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.
VCSN+Pro Model Number: PRT-01184-000, Package PN:PRT-01172-000. used for ventilatory…
Ventec Life Systems
Updated Sep 174,368 units units
Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interr…
Hazard. Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/1RO/130; Material Number…
Boston Scientific Cork
Updated Sep 162547 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/J/1RO/130; Material Number: M001195270
Boston Scientific Cork
Updated Sep 161912 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Direxion Torqueable Microcatheter, NGMC/FATHOM/021/BERN/1RO/130; Material Number…
Boston Scientific Cork
Updated Sep 163145 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Direxion Torqueable Microcatheter, NGMC/FATHOM/021/BERN/2RO/130; Material Number…
Boston Scientific Cork
Updated Sep 161442 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Direxion Torqueable Microcatheter, NGMC/FATHOM/021/STRAIGHT/1RO/130; Material Number…
Boston Scientific Cork
Updated Sep 161212 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Direxion Torqueable Microcatheter, NGMC/FATHOM/027/BERN/1RO/130; Material Number…
Boston Scientific Cork
Updated Sep 161135 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/1RO/155; Material Number…
Boston Scientific Cork
Updated Sep 161292 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Direxion Torqueable Microcatheter, NGMC/SINGLE/027/SWAN/1RO/130; Material Number…
Boston Scientific Cork
Updated Sep 161349 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/SWAN/1RO/130; Material Number…
Boston Scientific Cork
Updated Sep 163284 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/1RO/130; Material Number…
Boston Scientific Cork
Updated Sep 168542 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Direxion Torqueable Microcatheter, NGMC/TRANSEND/021/BERN/1RO/130; Material Number…
Boston Scientific Cork
Updated Sep 167945 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Silk sutures, indicated for use in cardiovascular, ophthalmic and neurological procedures, packaged with alcohol-based fluid, not part of p…
Hazard. Silk sutures, indicated for use in cardiovascular, ophthalmic and neurological procedures, packaged with alcohol-based fluid, not part of product design, that if discovered prior to use may cause surgical delay. If used, fluid could cause reduced suture tensile strength or knot security, tissue irritation/inflammatory tissue response, and treatment failure, including wound dehiscence/bleeding.
Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and ma…
Hazard. Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.
1) Product Name AUD OPEN HEART PACK, Medline Kit Number/SKU DYNJ22052I; 2) Product Name…
Medline Industries, LP
Updated Sep 21834 kits units
Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and ma…
Hazard. Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.
Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and ma…
Hazard. Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.
Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and ma…
Hazard. Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.
Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and ma…
Hazard. Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.
Sterile Passive spheres and biopsy needle kits contain variation in the reflective material which may affect the ability of the navigation …
Hazard. Sterile Passive spheres and biopsy needle kits contain variation in the reflective material which may affect the ability of the navigation system to detect and track the spheres.
cPM Series Patient Monitor. Operator's Manual: cPM 8/cPM 12
Mindray DS USA
Updated Aug 311,699 units units
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiologi…
Hazard. Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and sy…
Hazard. Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result in delays or ending procedures.
Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and sy…
Hazard. Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result in delays or ending procedures.
Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and sy…
Hazard. Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result in delays or ending procedures.
Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and sy…
Hazard. Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result in delays or ending procedures.
Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and sy…
Hazard. Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result in delays or ending procedures.
Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and sy…
Hazard. Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result in delays or ending procedures.
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiologi…
Hazard. Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 18" 1 LINE (10) Model/Catalog…
ASP Global
Updated Aug 242750 units
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 30" 1 LINE (10) Model/Catalog…
ASP Global
Updated Aug 241100 units
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 24" 1 LINE (10) Model/Catalog…
ASP Global
Updated Aug 241740 units
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Ingenia 3.0T and Ingenia 3.0T CX; Model Numbers (REF): 1. 781342(3.0T), 2. 781377(3.0T)…
Philips North America
Updated Aug 211447 units
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such th…
Hazard. A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.
Ingenia 1.5T, Ingenia 1.5T CX and Ingenia 1.5T S; Model Numbers (REF): 1. 781315(1.5T)…
Philips North America
Updated Aug 212038 units
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such th…
Hazard. A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.
The ABL90 FLEX and ABL90 FLEX PLUS analyzers are intended for use by trained…
Radiometer Medical ApS
Updated Aug 185395 units
In vitro diagnostic analyzer had a risk of potentially inaccurate results requiring changes to instructions for use and: 1) Sample types, i…
Hazard. In vitro diagnostic analyzer had a risk of potentially inaccurate results requiring changes to instructions for use and: 1) Sample types, including whole blood samples no longer suitable for testing FHbF and ctBil, 2) Reportable ranges for some parameters, 3) Analyzer configuration, and 4) limitations and warnings.
MAS Omni IMMUNE PRO Liquid Assayed Integrated Immunoassay Control, Level 1, REF…
Microgenics
Updated Aug 171366 units
Vial-to-vial variability in MAS¿ Omni"IMMUNE PRO Liquid Assayed Integrated Immunoassay Control, Level 1, Lot OPRO29061A results in low Para…
Hazard. Vial-to-vial variability in MAS¿ Omni"IMMUNE PRO Liquid Assayed Integrated Immunoassay Control, Level 1, Lot OPRO29061A results in low Parathyroid Hormone (PTH) recovery, which may lead to a delay in reporting patient PTH results.
The rinse-line check valve has a shorter service lifespan than originally expected and requires annual replacement to prevent lamina fluid …
Hazard. The rinse-line check valve has a shorter service lifespan than originally expected and requires annual replacement to prevent lamina fluid leakage; however, the check valve replacement was excluded from the annual preventive maintenance (PM) requirements without adequate reliability evaluation. When the check valve is not replaced annually, it may allow lamina fluid to migrate internally and leak…
Wheels may come loose when module is being pushed or pulled during movement or transportation, affecting stability of the stand. The stand …
Hazard. Wheels may come loose when module is being pushed or pulled during movement or transportation, affecting stability of the stand. The stand may tip over as a result. Falling stand may cause impact or crushing injuries, particularly to the feet, legs, hands or arms of the operator or nearby persons.
Potential for failure of the tension bolt which would allow the spring arm to unexpectedly fall to its lowest position, which is approximat…
Hazard. Potential for failure of the tension bolt which would allow the spring arm to unexpectedly fall to its lowest position, which is approximately 25 inches (63.5 cm) from the ground.
Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier m…
Hazard. Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit discoloration, melting, smoke, burning odor, or other signs of localized thermal damage. Device failure may predispose infant to bronchospasm, inspissated secretions, and airway obstruction, as well as inadvertent positive end-expiratory pressure (P…
munevo DRIVE and munevo DRIVE r-net Powered Wheelchair Hands-Free Control…
MUNEVO
Updated Jun 1919 units
A software issue may cause the wheelchair's driving mechanism to fall out of calibration. When this occurs, the device may experience unexp…
Hazard. A software issue may cause the wheelchair's driving mechanism to fall out of calibration. When this occurs, the device may experience unexpected steering drift or imprecise control while driving the wheelchair. The wheelchair may veer from its intended path, which may cause in low-speed collision, tipping, or injuries to user or bystanders.
Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer…
Accuray
Updated Jun 1648 units units
In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If pers…
Hazard. In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If personnel then enter the treatment room and initiate motion using the in-room control pendant, the collimator may release and fall from the housing.
Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer…
Accuray
Updated Jun 16292 units units
In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If pers…
Hazard. In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If personnel then enter the treatment room and initiate motion using the in-room control pendant, the collimator may release and fall from the housing.
Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary…
American Contract Systems
Updated Aug 101,804 kits total units
Kits contain manufacturer-recalled perineal care (pericare) wipes within urinary catheter trays, which may be contaminated with a lubricant…
Hazard. Kits contain manufacturer-recalled perineal care (pericare) wipes within urinary catheter trays, which may be contaminated with a lubricant used during the manufacturing process. Use of a contaminated wipe may lead to localized skin effects such as irritation, erythema, or mild inflammation. Failure to perform pericare due to disposal of contaminated wipes may increase risk of localized infection…
Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary…
American Contract Systems
Updated Aug 101,804 kits total units
Kits contain manufacturer-recalled perineal care (pericare) wipes within urinary catheter trays, which may be contaminated with a lubricant…
Hazard. Kits contain manufacturer-recalled perineal care (pericare) wipes within urinary catheter trays, which may be contaminated with a lubricant used during the manufacturing process. Use of a contaminated wipe may lead to localized skin effects such as irritation, erythema, or mild inflammation. Failure to perform pericare due to disposal of contaminated wipes may increase risk of localized infection…
The kits contain applicators that may exhibit an open or incomplete seal on the packaging of the applicator. Use of a potentially contamina…
Hazard. The kits contain applicators that may exhibit an open or incomplete seal on the packaging of the applicator. Use of a potentially contaminated applicator could result in no patient harm or may lead to localized skin or soft tissue infection. Less commonly, systemic infection or other infectious complications may occur.
The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin lev…
Hazard. The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could require medical intervention, such as neurovascular adverse events, febrile response, and/or local transient inflammation, hypotension, or nausea.
5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8
Fresenius Medical Care Renal Therapies Group
Updated Aug 106,624 units units
Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during tre…
Hazard. Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia.
Centricity Enterprise Archive V2, V3, and V4, software product for receiving, archiving…
GE Healthcare
Updated Jul 311856 systems units
Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. …
Hazard. Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the wrong patient record, which could lead to misdiagnosis or a delay in patient care.
Centricity PACS V2, V3, V4, V6, V7, software product is intended for the storage…
GE Healthcare
Updated Jul 311443 systems units
Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. …
Hazard. Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the wrong patient record, which could lead to misdiagnosis or a delay in patient care.
Enterprise Archive V8, software product for receiving, archiving, and sending electronic…
GE Healthcare
Updated Jul 311298 systems units
Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. …
Hazard. Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the wrong patient record, which could lead to misdiagnosis or a delay in patient care.
StatStrip Glucose and B- Ketone meter. Model No: 63683. Glucose test system.
Nova Biomedical
Updated Jul 291,858 units units
A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermitten…
Hazard. A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previously scanned barcode including patient identification (ID) barcodes and quality control (QC) solution ID barcodes when a new barcode is scanned, resulting in the prior barcode information remaining displayed on the screen for the current tes…
StatStrip Glucose and B- Ketone meter. Model No: 63910. Glucose test system.
Nova Biomedical
Updated Jul 298,939 units units
A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermitten…
Hazard. A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previously scanned barcode including patient identification (ID) barcodes and quality control (QC) solution ID barcodes when a new barcode is scanned, resulting in the prior barcode information remaining displayed on the screen for the current tes…
AMS Convenience Kit: DSAEK Pack - RX, Part Number AMS12394B
Windstone Medical Packaging
Updated Jul 293,260 kits units
The convenience kits contain .0.9% Sodium Chloride Injection, USP products in Single Dose freeflex bags, which may contain blue Break-off-P…
Hazard. The convenience kits contain .0.9% Sodium Chloride Injection, USP products in Single Dose freeflex bags, which may contain blue Break-off-Parts (BOPs) that have detached from the infusion port during manipulation.
StatStrip Glucose and B- Ketone meter. Model No: 66429. Glucose test system.
Nova Biomedical
Updated Jul 292,044 units units
A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermitten…
Hazard. A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previously scanned barcode including patient identification (ID) barcodes and quality control (QC) solution ID barcodes when a new barcode is scanned, resulting in the prior barcode information remaining displayed on the screen for the current tes…
The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufac…
Hazard. The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is used on a patient, localized skin effects may occur. These may include irritation, erythema, or mild inflammation.
The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufac…
Hazard. The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is used on a patient, localized skin effects may occur. These may include irritation, erythema, or mild inflammation.
Blood culture convenience kits contain a component subject to a drug recall that due to an an open or incomplete seal on the packaging of t…
Hazard. Blood culture convenience kits contain a component subject to a drug recall that due to an an open or incomplete seal on the packaging of the applicator may compromise the component's sterile barrier and if used may lead to localized skin or soft tissue infection.
Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1 mL…
AVID Medical
Updated Jul 22192 kits (4 cases) units
Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may exhibit an open or incomplete seal on the packaging of the app…
Hazard. Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may exhibit an open or incomplete seal on the packaging of the applicator.
Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System REF#…
Paragonix Technologies
Updated Jul 201445 systems units
Due to a firmware defect, the portable organ transfer device datalogger may lose its configuration, resulting in a blank screen and loss of…
Hazard. Due to a firmware defect, the portable organ transfer device datalogger may lose its configuration, resulting in a blank screen and loss of displayed preservation parameters.
Two software related issues: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inap…
Hazard. Two software related issues: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment and 2) Potential loss of geometry movements that may lead to delay of therapy and procedural complications
Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled …
Hazard. Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential out-of-specification levels of endotoxin of the neurosponges.
Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled …
Hazard. Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential out-of-specification levels of endotoxin of the neurosponges.
Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic
Siemens Healthcare Diagnostics
Updated Jul 67018 units units
Processing of urine albumin assay on the CI analyzers may lead to the following issues: Falsely depressed Atellica CH Urea Nitrogen (UN_c) …
Hazard. Processing of urine albumin assay on the CI analyzers may lead to the following issues: Falsely depressed Atellica CH Urea Nitrogen (UN_c) results; Falsely depressed Atellica CH Enzymatic Hemoglobin A1c (A1c_E) results; Increased rate of reaction cuvette QC failures and Delayed results due to QC failures.
Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: 191126…
Fresenius Medical Care Renal Therapies Group
Updated Jun 301140 systems units
Fresenius Medical Care Renal Therapies Group, LLC (FMCRTG) has received complaints regarding flow-, no water-, or temperature-related alarm…
Hazard. Fresenius Medical Care Renal Therapies Group, LLC (FMCRTG) has received complaints regarding flow-, no water-, or temperature-related alarms with the 2008T¿ BlueStar Hemodialysis machines.
Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to th…
Hazard. Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life. Reduced bleach concentration may compromise the effectiveness of disinfection, potentially allowing for the survival and persistence of pathogenic microorganisms.
Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated…
Contego Medical
Updated Jun 295069 units
Carotid stent and post-dilation balloon system with integrated embolic protection system has an integrated filter, that due to a wire-to-fi…
Hazard. Carotid stent and post-dilation balloon system with integrated embolic protection system has an integrated filter, that due to a wire-to-filter-bond issue, may fail to open following sheath retraction; and if this condition were to occur during a procedure, the result may be loss of intended integrated embolic protection.
EOPA 3D Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an…
Medtronic Perfusion Systems
Updated Jun 243,621 units units
Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hy…
Hazard. Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration or perforation, hypotension, ischemia, and organ dysfunction.
EOPA 3D Arterial Cannula 22FR, intended for use with cardiopulmonary bypass as an…
Medtronic Perfusion Systems
Updated Jun 241,424 units units
Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hy…
Hazard. Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration or perforation, hypotension, ischemia, and organ dysfunction.
EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with…
Medtronic Perfusion Systems
Updated Jun 243,110 units units
Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hy…
Hazard. Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration or perforation, hypotension, ischemia, and organ dysfunction.
Spinal cord stimulation system lead body may be exposed to stress at the anchor site. This may result in high impedance measurements or lea…
Hazard. Spinal cord stimulation system lead body may be exposed to stress at the anchor site. This may result in high impedance measurements or lead fractures, which may lead to inadequate stimulation, additional intervention, including lead explant and replacement.
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Loop Recorder Pack…
Windstone Medical Packaging
Updated Jun 173378 kits units
Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing …
Hazard. Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplier quality issues.
MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android)
Medtronic MiniMed
Updated Jun 163,465 units
For MiniMed Go app version 1.0.0 and 1.1.0, when the Set day and night is turned OFF and missed dose or Correct high glucose alerts are ena…
Hazard. For MiniMed Go app version 1.0.0 and 1.1.0, when the Set day and night is turned OFF and missed dose or Correct high glucose alerts are enabled, the associated alerts will not be triggered during the nighttime. This could result in missed rapid-acting insulin doses without the user s knowledge, and may lead to delayed therapy and an increased risk of hyperglycemia.
L-Cath PICC S/L Peripherally Inserted Central Catheter: 26ga (1.9F) 0.60mm x 30cm, REF…
Argon Medical Devices
Updated Jun 156928 units
Catheters, indicated for short/long-term peripheral access to central venous system for the administration of fluids, medications, nutrient…
Hazard. Catheters, indicated for short/long-term peripheral access to central venous system for the administration of fluids, medications, nutrients; and sampling, may experience leaking and/or cracking at the hub, which may lead to replacement, inability to flush/aspirate catheter, catheter occlusion, therapy interruption, blood loss, tissue irritation, bloodstream infection.
Medline Convenience Kits: 1) ARTERIAL LINE INSERTION KIT, Model Number: ART1295
Medline Industries, LP
Updated Jun 121840 kits units
The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging,…
Hazard. The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less com…
The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging,…
Hazard. The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less com…
Medline Convenience Kits: 1) EYE KIT, Model Number: DYKM2751; 2) EYE KIT, Model Number…
Medline Industries, LP
Updated Jun 122080 kits units
The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging,…
Hazard. The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less com…
The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging,…
Hazard. The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less com…
The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging,…
Hazard. The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less com…
ABIOMED Impella CP Introducer Kit 14 Fr, 13 cm, Pump Set Code 0052-0038, containing Kit…
Abiomed
Updated Jun 111,540 units units
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers.…
Hazard. A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
Medline medical convenience kits labeled as: 1) TOTAL JOINT PACK Medline Kit SKU…
Medline Industries, LP
Updated Jun 111601 units units
Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with…
Hazard. Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species.
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers.…
Hazard. A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
ABIOMED Impella RP Flex with SmartAssist Set, Pump Set Code 1000323, containing Kit, 23Fr…
Abiomed
Updated Jun 115,017 units units
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers.…
Hazard. A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers.…
Hazard. A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
ABIOMED Impella CP Introducer Kit 14 Fr, 25 cm, Pump Set Code 0052-0039, containing Kit…
Abiomed
Updated Jun 111,223 units units
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers.…
Hazard. A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
ICU Medical Plum Solo Precision IV Pump, v1.0.3, Item Number 400010401; infusion pump
ICU Medical
Updated Jun 105059 units units
In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to …
Hazard. In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.
Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, …
Hazard. Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region.
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Laminectomy Pack…
Windstone Medical Packaging
Updated Jun 87306 units units
The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological S…
Hazard. The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products.
Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochl…
Hazard. Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochloride in Dextrose Injection, USP. B. Braun Medical Inc. was notified by their supplier, Spectra Medical Devices, LLC of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. Huons Co, Ltd. has issued a …
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria f…
Hazard. Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the …
Hazard. Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen damage, and breakage, and may lead to infection, medication loss, and/or blood loss.
Medline Convenience kits containing recalled Swan-Ganz Catheters CENTRAL AND ARTERIAL…
Medline Industries, LP
Updated May 289,272 kits units
Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the …
Hazard. Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen damage, and breakage, and may lead to infection, medication loss, and/or blood loss.
Medline Convenience kits containing recalled Swan-Ganz Catheters OPEN HEART DYNJ909090B…
Medline Industries, LP
Updated May 289,272 kits units
Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the …
Hazard. Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen damage, and breakage, and may lead to infection, medication loss, and/or blood loss.
Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the …
Hazard. Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen damage, and breakage, and may lead to infection, medication loss, and/or blood loss.
Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the …
Hazard. Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen damage, and breakage, and may lead to infection, medication loss, and/or blood loss.
Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medtronic has issued a recall of specific produ…
Hazard. Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medtronic has issued a recall of specific production lots of the Covidien Mon-a-Therm general purpose temperature probe-size 9 due to an error in its distribution control process.
Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the …
Hazard. Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen damage, and breakage, and may lead to infection, medication loss, and/or blood loss.
Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the …
Hazard. Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen damage, and breakage, and may lead to infection, medication loss, and/or blood loss.
Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the …
Hazard. Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen damage, and breakage, and may lead to infection, medication loss, and/or blood loss.
Devices containing inner shaft assemblies from specific manufacturing lots may have an increased potential for distal tip detachment from t…
Hazard. Devices containing inner shaft assemblies from specific manufacturing lots may have an increased potential for distal tip detachment from the delivery system under certain procedural or anatomical conditions due to a manufacturing issue.
Medline Convenience Kits: 1) PAIN MGMT/ PREF W. MED NDL, Model Number: PAIN0072L; 2)…
Medline Industries, LP
Updated May 211,512 kits units
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons …
Hazard. The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently bein…
Hazard. Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
A M S, ALIGNED MEDICAL SOLUTIONS, DSAEK Pack-RX, Pack Number AMS12394B, surgical…
Windstone Medical Packaging
Updated May 211080 kits units
Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus p…
Hazard. Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently bein…
Hazard. Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently bein…
Hazard. Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons …
Hazard. The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently bein…
Hazard. Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
American Contract Systems medical procedure kits and trays labeled as: 1) CRANI PACK…
American Contract Systems
Updated May 194789 kits units
The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological S…
Hazard. The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products.
GSP Neonatal GALT Kit. Product Codes: 3303-001U, 3303-0010. in vitro diagnostic. Used in…
WALLAC OY
Updated May 183,274 units units
Reduction in the on-board stability of the GSP GALT assay. This may increase the likelihood of run-QC failures and consequently delay the r…
Hazard. Reduction in the on-board stability of the GSP GALT assay. This may increase the likelihood of run-QC failures and consequently delay the reporting of patient results.
IV Non-Dedicated Gravity Administration Sets with drip chambers
ICU Medical
Updated May 122,450 units
Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolor…
Hazard. Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall that does not enter the fluid path, which if seen by a healthcare provider may lead to replacement of product before use, which could result in a delay in therapy.
Orca Single Use Air/Water and Suction Valves, Material Number (UPN) SUV-617-50; The Orca…
Boston Scientific
Updated May 129750 units units
Boston Scientific is initiating a medical device removal of Orca Sterile, Single Use Air/Water and Suction Valves due to a higher than anti…
Hazard. Boston Scientific is initiating a medical device removal of Orca Sterile, Single Use Air/Water and Suction Valves due to a higher than anticipated occurrence of the suction button sticking.
A potential positive bias in quality control (QC) and patient sample results in three lots of the Dimension Tacrolimus (TAC) Flex reagent c…
Hazard. A potential positive bias in quality control (QC) and patient sample results in three lots of the Dimension Tacrolimus (TAC) Flex reagent cartridge.
There is an error in the labeling of the GTIN on the product. When scanned; however, the case labeling, lot number, and printed labeling on…
Hazard. There is an error in the labeling of the GTIN on the product. When scanned; however, the case labeling, lot number, and printed labeling on the product correctly identifies the product code and the solution contained in the bag. In the event the incorrect GTIN labeling is used as the singular source for product identification, unrecognized use of a potassium solution with a concentration differin…
Atlan A350. Model Number: 8211500. anesthesia workstation
Draeger
Updated May 73,515 units units
The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ven…
Hazard. The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
Complaint trend where "Checkline Error" alarm presents at device setup, rendering the CO2 monitoring function inoperable. May result in pro…
Hazard. Complaint trend where "Checkline Error" alarm presents at device setup, rendering the CO2 monitoring function inoperable. May result in procedure delay.
Medline Convenience Kits: 1) OPEN HEART CDS, Model Number: CDS840144Q; 2) OPEN HEART…
Medline Industries, LP
Updated May 66775 units units
The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride …
Hazard. The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were recalled due to quality issues identified during a recent FDA inspection of the supplier.
HexaVue Focus Integration System, a single, all-in-one system that handles operating room…
Steris
Updated Sep 2358 systems units
A software issue may result in unintended mismatch of patient information on manually printed images. Incorrect patient information appeari…
Hazard. A software issue may result in unintended mismatch of patient information on manually printed images. Incorrect patient information appearing on printed images could create a documentation discrepancy or incorrect association of clinical images with a patient record.
ROTOR ASSY-SW41, Reference Number 331362, when the rotors are installed in the following…
Beckman Coulter
Updated Sep 21336 units units
Rotors have been found with a non-conforming microstructure, which may result in some rotors breaking into two or more pieces during use. R…
Hazard. Rotors have been found with a non-conforming microstructure, which may result in some rotors breaking into two or more pieces during use. Rotors that break into multiple pieces during use may result in significant damage to materials (i.e., samples) being processed in the centrifuge and to the centrifuge instrument.
ROTOR ASSY-SW40, Reference Number 331302, when the rotors are installed in the following…
Beckman Coulter
Updated Sep 2192 units units
Optima XE XPN ultracentrifuge rotors may contain a microstructure defect that can cause rotors to break into two or more pieces (bifurcate)…
Hazard. Optima XE XPN ultracentrifuge rotors may contain a microstructure defect that can cause rotors to break into two or more pieces (bifurcate) during a centrifugation run, resulting in destruction of samples being processed. When used for in vitro diagnostic (IVD) sample preparation, rotor breakage may delay patient test results. Additionally, sample destruction may expose laboratory personnel to bi…
RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020115
Steris
Updated Sep 21374 units units
If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased internal pressure. In some cases, excess va…
Hazard. If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased internal pressure. In some cases, excess vapor or liquid chemistry may escape from the bottle when the cap is twisted during opening, which could result in user exposure if required personal protective equipment (PPE) is not properly used. Such exposure may result in injury to the user or others in clo…
VC Model Number: PRT-01098-000, Package PN:PRT-01125-000. used for ventilatory support.
Ventec Life Systems
Updated Sep 17930 units units
Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interr…
Hazard. Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.
VC+Pro (Japan) Model Number: PRT-00900-100, Package PN:PRT-00973-100. used for…
Ventec Life Systems
Updated Sep 17606 units units
Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interr…
Hazard. Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.
VOCSN+Pro (Japan), Model Number: PRT-00490-100, Package PN:PRT-00853-100. used for…
Ventec Life Systems
Updated Sep 17325 units units
Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interr…
Hazard. Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.
VC(Japan) Model Number: PRT-01098-100, Package PN:PRT-01125-100. used for ventilatory…
Ventec Life Systems
Updated Sep 17180 units units
Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interr…
Hazard. Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.
VOCSN (Japan) Model Number: PRT-01100-100, Package PN:PRT-01126-100. used for ventilatory…
Ventec Life Systems
Updated Sep 17100 units units
Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interr…
Hazard. Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.
Williams Cystoscopic Injection Needles, used for cystoscopic injection into the urethra…
Cook
Updated Sep 1697 units units
The female Luer lock adapter component in the affected device lots may not have been correctly seated due to misalignment and inadequate to…
Hazard. The female Luer lock adapter component in the affected device lots may not have been correctly seated due to misalignment and inadequate torquing during manufacturing. Potential events that may occur as a result of this issue include increased procedural time and inadequate treatment.
Triathlon Hinge Femoral Prep Tray. Catalog Number: 6543-6-514.
Howmedica Osteonics
Updated Sep 16359 trays units
Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When bl…
Hazard. Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the 30-minute dry time may lead to a small amount of residual moisture remaining after sterilization.
Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When bl…
Hazard. Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the 30-minute dry time may lead to a small amount of residual moisture remaining after sterilization.
Direxion Torqueable Microcatheter, NGMC/FATHOM/027/STRAIGHT/1RO/130; Material Number…
Boston Scientific Cork
Updated Sep 16609 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/2RO/155; Material Number…
Boston Scientific Cork
Updated Sep 16206 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/2RO/130; Material Number…
Boston Scientific Cork
Updated Sep 16632 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Direxion Torqueable Microcatheter, NGMC/FATHOM/021/BERN/1RO/155; Material Number…
Boston Scientific Cork
Updated Sep 16860 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Direxion Torqueable Microcatheter, NGMC/TRANSEND/021/BERN/1RO/155; Material Number…
Boston Scientific Cork
Updated Sep 16926 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Direxion Torqueable Microcatheter, NGMC/SINGLE/027/J/1RO/155; Material Number: M001195480
Boston Scientific Cork
Updated Sep 1645 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Direxion Torqueable Microcatheter, NGMC/SINGLE/027/BERN/1RO/105; Material Number…
Boston Scientific Cork
Updated Sep 1676 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Direxion Torqueable Microcatheter, NGMC/SINGLE/027/SWAN/1RO/155; Material Number…
Boston Scientific Cork
Updated Sep 16112 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Direxion Torqueable Microcatheter, NGMC/SINGLE/027/J/1RO/130; Material Number: M001195470
Boston Scientific Cork
Updated Sep 16382 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Direxion Torqueable Microcatheter, NGMC/FATHOM/021/STRAIGHT/2RO/130; Material Number…
Boston Scientific Cork
Updated Sep 16156 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Direxion Torqueable Microcatheter, NGMC/FATHOM/021/STRAIGHT/1RO/155; Material Number…
Boston Scientific Cork
Updated Sep 16598 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Direxion Torqueable Microcatheter, NGMC/SINGLE/027/STRAIGHT/1RO/105; Material Number…
Boston Scientific Cork
Updated Sep 1639 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Direxion Torqueable Microcatheter, NGMC/FATHOM/027/STRAIGHT/1RO/155; Material Number…
Boston Scientific Cork
Updated Sep 16378 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Philips Smart-hopping 2.0 AP 1.4 GHz; Product/Model Number: 867216;
Philips North America
Updated Sep 16174 units
Unreliable wireless roaming behavior of Smart-hopping 1.0 wireless clients during transport when connecting to Smart-hopping 2.0 infrastruc…
Hazard. Unreliable wireless roaming behavior of Smart-hopping 1.0 wireless clients during transport when connecting to Smart-hopping 2.0 infrastructure, resulting in loss of connectivity to the central monitoring system (PIC iX).
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/SWAN/1RO/155; Material Number…
Boston Scientific Cork
Updated Sep 16486 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Direxion Torqueable Microcatheter, NGMC/SINGLE/027/STRAIGHT/1RO/130; Material Number…
Boston Scientific Cork
Updated Sep 16902 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/1RO/155; Material Number…
Boston Scientific Cork
Updated Sep 16459 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/1RO/105; Material Number…
Boston Scientific Cork
Updated Sep 16126 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Direxion Torqueable Microcatheter, NGMC/SINGLE/027/STRAIGHT/1RO/155; Material Number…
Boston Scientific Cork
Updated Sep 16228 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/2RO/155; Material Number…
Boston Scientific Cork
Updated Sep 16384 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Direxion Torqueable Microcatheter, NGMC/TRANSEND/027/BERN/1RO/130; Material Number…
Boston Scientific Cork
Updated Sep 16550 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Direxion Torqueable Microcatheter, NGMC/TRANSEND/027/STRAIGHT/1RO/130; Material Number…
Boston Scientific Cork
Updated Sep 1686 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Direxion Torqueable Microcatheter, NGMC/SINGLE/027/BERN/1RO/155; Material Number…
Boston Scientific Cork
Updated Sep 16357 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/1RO/105; Material Number…
Boston Scientific Cork
Updated Sep 16689 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Direxion Torqueable Microcatheter, NGMC/TRANSEND/021/STRAIGHT/1RO/130; Material Number…
Boston Scientific Cork
Updated Sep 16658 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/2RO/130; Material Number…
Boston Scientific Cork
Updated Sep 16748 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/J/1RO/105; Material Number: M001195260
Boston Scientific Cork
Updated Sep 16358 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/J/1RO/155; Material Number: M001195280
Boston Scientific Cork
Updated Sep 16381 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Direxion Torqueable Microcatheter, NGMC/FATHOM/027/BERN/1RO/155; Material Number…
Boston Scientific Cork
Updated Sep 16432 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Direxion Torqueable Microcatheter, NGMC/SINGLE/027/BERN/1RO/130; Material Number…
Boston Scientific Cork
Updated Sep 16620 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/SWAN/1RO/105; Material Number…
Boston Scientific Cork
Updated Sep 1642 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When bl…
Hazard. Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the 30-minute dry time may lead to a small amount of residual moisture remaining after sterilization.
Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When bl…
Hazard. Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the 30-minute dry time may lead to a small amount of residual moisture remaining after sterilization.
CareLink Clinic software version 4.4A includes a software defect in the Settings Calculator feature in which the calculation logic fails to…
Hazard. CareLink Clinic software version 4.4A includes a software defect in the Settings Calculator feature in which the calculation logic fails to use custom values entered by healthcare professionals (HCPs) for Total Daily Dose (TDD) or Long-acting insulin when calculating the Carb Ratio, Insulin Sensitivity Factor (ISF), and Max Recommended value for Rapid-acting insulin. Instead, the calculator conti…
NaviFlex LW Pusher; Advx Panc. Stent 4/5F; Material Number (UPN): M00535030;
Boston Scientific
Updated Sep 10403 units
Device was incorrectly manufactured with a guidewire exit port (referred to in the IFU as the RX port), which is not a design feature assoc…
Hazard. Device was incorrectly manufactured with a guidewire exit port (referred to in the IFU as the RX port), which is not a design feature associated with this device configuration.
Halyard ANTERIOR HIP PACK. Model/Catalog Number: SOAH31.
AVID Medical
Updated Sep 856 kits units
A non-sterile component was piggybacked and incorrectly placed outside of the sterile barrier and not subjected to EO sterilization per kit…
Hazard. A non-sterile component was piggybacked and incorrectly placed outside of the sterile barrier and not subjected to EO sterilization per kit specifications.
Halyard ANTERIOR HIP PACK. Model/Catalog Number: SOAH30.
AVID Medical
Updated Sep 880 kits units
A non-sterile component was piggybacked and incorrectly placed outside of the sterile barrier and not subjected to EO sterilization per kit…
Hazard. A non-sterile component was piggybacked and incorrectly placed outside of the sterile barrier and not subjected to EO sterilization per kit specifications.
Product Name: Nihon Kohden CNS-6200 Series Central Nurse Station, Model/Catalog Number…
Nihon Kohden America
Updated Sep 8808 units
Due to a cybersecurity issue associate with a NULL Pointer Dereferences vulnerabiity. If exploited would potentially cause disruption of th…
Hazard. Due to a cybersecurity issue associate with a NULL Pointer Dereferences vulnerabiity. If exploited would potentially cause disruption of the centralized monitoring of multiple beds and the visualization of alarms.
LeadCare II Blood Lead Test Kit. Model/Catalog Number: 70-6762.
Magellan Diagnostics
Updated Sep 4321 units units
In kit sub-lot 2530M-01 the date of expiration printed on the outer labeling may indicate the wrong expiration date of July 22, 2026 while …
Hazard. In kit sub-lot 2530M-01 the date of expiration printed on the outer labeling may indicate the wrong expiration date of July 22, 2026 while the correct expiration date is July 13, 2026. If used the system will display an error message and prevent the operator from running the test. Resulting in delayed results.
Generic Name: MiniMed Go App Generic Name: MiniMed Go App Model/Catalog Number: MMT-8600…
Medtronic MiniMed
Updated Sep 2623 units
A software defect in which existing users who had previously configured and enabled the long-acting dose reminder feature in version 1.2.0 …
Hazard. A software defect in which existing users who had previously configured and enabled the long-acting dose reminder feature in version 1.2.0 or earlier experienced failure of the long-acting dose reminder after updating their app to version 1.2.1. The long-acting dose reminder is an optional feature that, when enabled, triggers a notification at the scheduled time to remind users to take their long…
Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and ma…
Hazard. Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.
Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and ma…
Hazard. Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.
Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and ma…
Hazard. Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.
Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and ma…
Hazard. Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.
Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and ma…
Hazard. Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiologi…
Hazard. Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
Upgrade dStream; Model number (REF): 782127; Software Versions: R11, R12 and R13;
Philips North America
Updated Aug 281 units
When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data…
Hazard. When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction with third-party software for tractography (e.g. for mapping nerve fiber pathways in the brain), the software will not be able to correctly process the DTI data for reconstruction.
Evolution upgrade 1.5T amd Evolution upgrade 3.0T; Model number (REF): 1. 782116 (1.5T)…
Philips North America
Updated Aug 2891 units
When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data…
Hazard. When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction with third-party software for tractography (e.g. for mapping nerve fiber pathways in the brain), the software will not be able to correctly process the DTI data for reconstruction.
Ingenia 1.5T, 1.5T CX, and 1.5T S; Model number (REF): 1. 781315 (1.5T), 2. 781341…
Philips North America
Updated Aug 28216 units
When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data…
Hazard. When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction with third-party software for tractography (e.g. for mapping nerve fiber pathways in the brain), the software will not be able to correctly process the DTI data for reconstruction.
MR 7700; Model number (REF): 1. 782120, 2. 782153, 3. 782155, 4. 782199; Software…
Philips North America
Updated Aug 28107 units
When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data…
Hazard. When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction with third-party software for tractography (e.g. for mapping nerve fiber pathways in the brain), the software will not be able to correctly process the DTI data for reconstruction.
Ingenia 3.0T and 3.0T CX; Model number (REF): 1. 781342 (3.0T), 2. 781377 (3.0T), 3…
Philips North America
Updated Aug 28243 units
When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data…
Hazard. When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction with third-party software for tractography (e.g. for mapping nerve fiber pathways in the brain), the software will not be able to correctly process the DTI data for reconstruction.
A navigation system used to aid in selection and positioning of orthopedic implant system components has a workstation that may contain a 1…
Hazard. A navigation system used to aid in selection and positioning of orthopedic implant system components has a workstation that may contain a 15-inch MacBook Pro battery, subject to an Apple battery recall, that may overheat and pose a fire safety risk.
Ingenia Elition S and Ingenia Elition X.; Model number (REF): 1. 781357 (S), 2. 782106…
Philips North America
Updated Aug 28340 units
When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data…
Hazard. When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction with third-party software for tractography (e.g. for mapping nerve fiber pathways in the brain), the software will not be able to correctly process the DTI data for reconstruction.
Ingenia Ambition S and Ingenia Ambition X.; Model number (REF): 1. 781359 (S), 2. 782108…
Philips North America
Updated Aug 28422 units
When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data…
Hazard. When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction with third-party software for tractography (e.g. for mapping nerve fiber pathways in the brain), the software will not be able to correctly process the DTI data for reconstruction.
Ingenia Blue Seal SE and Blue Seal XE; Model number (REF): 1. 782185 (SE), 2. 782192…
Philips North America
Updated Aug 286 units
When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data…
Hazard. When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction with third-party software for tractography (e.g. for mapping nerve fiber pathways in the brain), the software will not be able to correctly process the DTI data for reconstruction.
SmartPath to MR 7700; Model number (REF): 1. 782178, 2. 782207; Software Versions: R11…
Philips North America
Updated Aug 285 units
When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data…
Hazard. When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction with third-party software for tractography (e.g. for mapping nerve fiber pathways in the brain), the software will not be able to correctly process the DTI data for reconstruction.
MR 5300; Model number (REF): 1. 782110, 2. 782152, 3. 782156, 4. 782196; Software…
Philips North America
Updated Aug 28131 units
When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data…
Hazard. When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction with third-party software for tractography (e.g. for mapping nerve fiber pathways in the brain), the software will not be able to correctly process the DTI data for reconstruction.
Loosening of the bolts securing the longitudinal movement mechanism may cause the tabletop to shift, resulting in [positional/imaging/patie…
Hazard. Loosening of the bolts securing the longitudinal movement mechanism may cause the tabletop to shift, resulting in [positional/imaging/patient] misalignment and a longitudinal motion error
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 26" DUAL BLADDER, 2 LINE (10)…
ASP Global
Updated Aug 2450 units
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 44" 2 LINE (10) Model/Catalog…
ASP Global
Updated Aug 24360 units
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 12" 2 LINE (10) Model/Catalog…
ASP Global
Updated Aug 2480 units
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Olympus M3 Gold Autoclavable Lateral Telescope 70. Model Number: M3-70A.
Olympus of the Americas
Updated Aug 2450 units units
There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters…
Hazard. There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese package insert.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 30" 2 LINE (10) Model/Catalog…
ASP Global
Updated Aug 24820 units
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 44" 1 LINE (10) Model/Catalog…
ASP Global
Updated Aug 24410 units
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 15" 2 LINE (10) Model/Catalog…
ASP Global
Updated Aug 24180 units
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 34" 1 LINE (10) Model/Catalog…
ASP Global
Updated Aug 24850 units
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Olympus M3 Gold Autoclavable Foroblique Telescope 30. Model Number: M3-30A.
Olympus of the Americas
Updated Aug 2472 units units
There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters…
Hazard. There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese package insert.
Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 12" 1 LINE (10) Model/Catalog…
ASP Global
Updated Aug 2430 units
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Spectral CT and Spectral CT 7500 RT; Software Version Numbers: 5.2.X (U.S.); 5.0.X…
PHILIPS MEDICAL SYSTEMS
Updated Aug 21539 units
Software issues may affect the safety and performance of Spectral CT system(s). The issues may result in image artifacts, wrong slice thick…
Hazard. Software issues may affect the safety and performance of Spectral CT system(s). The issues may result in image artifacts, wrong slice thickness, or unintended system motion.
iFuse TORQ Implant System Model/Catalog Number: 10055T(10x55mm), 10060T(10x60mm)…
SI-BONE
Updated Aug 21100 units units
The pelvic fixation screws failed to meet acceptance criteria for tube packaging seal integrity testing; therefore, sterility assurance can…
Hazard. The pelvic fixation screws failed to meet acceptance criteria for tube packaging seal integrity testing; therefore, sterility assurance cannot be ensured.
SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T, SmartPath to dStream for XR…
Philips North America
Updated Aug 21965 units
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such th…
Hazard. A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.
Achieva 1.5T, Achieva 1.5T Conversion and Achieva 1.5T Initial system; Model Numbers…
Philips North America
Updated Aug 21387 units
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such th…
Hazard. A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.
Ingenia Ambition S and Ingenia Ambition X; Model Numbers (REF): 1. 781359 (S), 2. 782108…
Philips North America
Updated Aug 21922 units
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such th…
Hazard. A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such th…
Hazard. A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.
Evolution upgrade 1.5T and Evolution upgrade 3.0T; Model Numbers (REF): 1. 782116 (1.5T)…
Philips North America
Updated Aug 2191 units
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such th…
Hazard. A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.
Achieva XR; Model Numbers (REF): 1. 781153, 2. 781253;
Philips North America
Updated Aug 2115 units
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such th…
Hazard. A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such th…
Hazard. A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.
MR 7700 and Upgrade to MR 7700; Model Number (REF): 1. 782120, 2. 782153, 3. 782130…
Philips North America
Updated Aug 2137 units
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such th…
Hazard. A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.
Ingenia Elition S and Ingenia Elition X; Model Numbers (REF): 1. 781357(S), 2. 782106(S)…
Philips North America
Updated Aug 21596 units
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such th…
Hazard. A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such th…
Hazard. A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.
Robotic system square drive failed to meet design specifications potentially resulting in pin becoming stuck in square driver or the pin wo…
Hazard. Robotic system square drive failed to meet design specifications potentially resulting in pin becoming stuck in square driver or the pin wobbling during drilling.
Some MiniMed Flex insulin pumps were released with missing (i.e., devices with no result or abort test results are presumed to have failed)…
Hazard. Some MiniMed Flex insulin pumps were released with missing (i.e., devices with no result or abort test results are presumed to have failed) or failed verification test results in one or more of 9 functional tests. The unverified/failed pumps released to users potentially have one or more of the following issues: inoperable pump at setup, lack of protection for moisture exposure, slow battery char…
EnCor EnCompass Breast Biopsy and Tissue Removal System Console (model number…
Bard Peripheral Vascular
Updated Aug 2099 units
Breast biopsy and tissue removal system may experience the following errors: 1) Probe calibration and /or handheld driver failure (code HH0…
Hazard. Breast biopsy and tissue removal system may experience the following errors: 1) Probe calibration and /or handheld driver failure (code HH01-00020009) , 2) Pressure sensor (code E01-0054000E), which prompts the user to restart and re-calibrate; errors may lead to interruption or prolongation of the biopsy procedure, or the need for additional tissue sampling or repeat biopsy.
Kits contain Microstream components. Medtronic issued an update to the Instructions for Use of these components due reports of difficulty i…
Hazard. Kits contain Microstream components. Medtronic issued an update to the Instructions for Use of these components due reports of difficulty in disconnecting the adapter from the patient's endotracheal tube to perform a procedure. The issue can result in a delay to treatment and unintended extubation. The potential exists for respiratory failure, hypoxia, aspiration, or low oxygen saturation.
Potential for the inflation chart label affixed to the shaft of the device to be incorrect and indicate a balloon diameter of 18, 19, or 20…
Hazard. Potential for the inflation chart label affixed to the shaft of the device to be incorrect and indicate a balloon diameter of 18, 19, or 20 mm,
BARD EP XT DECAPOLAR STEERABLE, DIAGNOSTIC EP CATHETER, 6F, LARGE 4.0, 10, 2-5-2MM, REF…
Stryker Sustainability Solutions
Updated Aug 1810 units
Diagnostic electrophysiology (EP) catheter may have a breached sterile barrier on the straight seal side of the primary pouch, which if use…
Hazard. Diagnostic electrophysiology (EP) catheter may have a breached sterile barrier on the straight seal side of the primary pouch, which if used could lead to particulate embolization, infection, thrombus or ganuloma formation from particulate matter.
Stimulator device contains a defective printed circuit board assembly (PCBA) that may cause the device to unintentionally deliver electrica…
Hazard. Stimulator device contains a defective printed circuit board assembly (PCBA) that may cause the device to unintentionally deliver electrical stimulation to the patient, or allow an unintended electrical current to reach the patient.
Philips Medical Systems Technologies Ltd. Spectral CT 7500, Software V5.2.x, Product Code…
Philips North America
Updated Aug 1862 units
The Bolus tracking scan application may crash with a system error message. Bolus Tracker shots may continue to occur even if the contrast t…
Hazard. The Bolus tracking scan application may crash with a system error message. Bolus Tracker shots may continue to occur even if the contrast threshold is reached. This may result in the patient receiving additional radiation.
Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems be…
Hazard. Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of volatile anesthetic agents, resulting in deeper/lighter anesthetic effects that may result in hypertonia/hypotonia, tachycardia/ bradycardia, elevated intracranial pressure, awareness during anesthesia, oversedation
CHARLOTTE CLAW Screw, REF: 40122716, intended for use with CLAW II Polyaxial Compression…
Wright Medical Technology
Updated Aug 1834 units
Screws, intended for use with polyaxial compression plating system intended for foot osteotomies, was manufactured with missing threads on …
Hazard. Screws, intended for use with polyaxial compression plating system intended for foot osteotomies, was manufactured with missing threads on the screwheads, which if used would prevent a secure rigid engagement with the plate's internal threads, which may lead to surgery prolongation to retrieve another device, or alternative surgery method if no replacement device is readily available.
There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align …
Hazard. There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align with the approved product or product specifications and may lead to incorrect product identification or selection, potentially resulting in use with an incompatible bed frame.
PRO+ MRS SURFACE FOR VERSACARE, mattress with Advanced Microclimate Technology (AMT) uses…
Baxter Healthcare
Updated Aug 18169 units units
There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align …
Hazard. There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align with the approved product or product specifications and may lead to incorrect product identification or selection, potentially resulting in use with an incompatible bed frame.
There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align …
Hazard. There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align with the approved product or product specifications and may lead to incorrect product identification or selection, potentially resulting in use with an incompatible bed frame.
A routine stability studies have identified a stability drift affecting the Ammonia (NH4+) analyte in specific lots of Multichem AE quality…
Hazard. A routine stability studies have identified a stability drift affecting the Ammonia (NH4+) analyte in specific lots of Multichem AE quality control material. Additional testing confirmed that the labelled shelf-life performance claim for the Ammonia analyte can no longer be supported for the affected lots. This issue is limited to the Ammonia analyte only. The impacted device may cause delay of i…
A routine stability studies have identified a stability drift affecting the Ammonia (NH4+) analyte in specific lots of Multichem AE quality…
Hazard. A routine stability studies have identified a stability drift affecting the Ammonia (NH4+) analyte in specific lots of Multichem AE quality control material. Additional testing confirmed that the labelled shelf-life performance claim for the Ammonia analyte can no longer be supported for the affected lots. This issue is limited to the Ammonia analyte only. The impacted device may cause delay of i…
A routine stability studies have identified a stability drift affecting the Ammonia (NH4+) analyte in specific lots of Multichem AE quality…
Hazard. A routine stability studies have identified a stability drift affecting the Ammonia (NH4+) analyte in specific lots of Multichem AE quality control material. Additional testing confirmed that the labelled shelf-life performance claim for the Ammonia analyte can no longer be supported for the affected lots. This issue is limited to the Ammonia analyte only. The impacted device may cause delay of i…
Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue combined with…
Medtronic Sofamor Danek USA
Updated Aug 1220 units
Medtronic identified through donor record review that the donor for Medtronic batch A62881 did not meet all Medtronic donor eligibility req…
Hazard. Medtronic identified through donor record review that the donor for Medtronic batch A62881 did not meet all Medtronic donor eligibility requirements related to the presence of microbial organisms. While the batch passed finished product sterility testing Medtronic is retrieving any unused product manufactured from the donor tissue. Donor bone tissue tested positive for Clostridium butyricum and w…
The rinse-line check valve has a shorter service lifespan than originally expected and requires annual replacement to prevent lamina fluid …
Hazard. The rinse-line check valve has a shorter service lifespan than originally expected and requires annual replacement to prevent lamina fluid leakage; however, the check valve replacement was excluded from the annual preventive maintenance (PM) requirements without adequate reliability evaluation. When the check valve is not replaced annually, it may allow lamina fluid to migrate internally and leak…
Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue combined with…
Medtronic Sofamor Danek USA
Updated Aug 1218 units
Medtronic identified through donor record review that the donor for Medtronic batch A62881 did not meet all Medtronic donor eligibility req…
Hazard. Medtronic identified through donor record review that the donor for Medtronic batch A62881 did not meet all Medtronic donor eligibility requirements related to the presence of microbial organisms. While the batch passed finished product sterility testing Medtronic is retrieving any unused product manufactured from the donor tissue. Donor bone tissue tested positive for Clostridium butyricum and w…
Computed Tomography X-ray System, Model: uCT ATLAS with software
Shanghai United Imaging Healthcare
Updated Aug 1111 units
Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and mul…
Hazard. Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images from being visible on the Patient Administration interface, which may result in the need for rescans.
Computed Tomography X-ray System, Model: uCT 780 with software
Shanghai United Imaging Healthcare
Updated Aug 1114 units
Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and mul…
Hazard. Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images from being visible on the Patient Administration interface, which may result in the need for rescans.
Positron Emission Tomography and Computed Tomography System, Model: uMI Panvivo S with…
Shanghai United Imaging Healthcare
Updated Aug 116 units
Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and mul…
Hazard. Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images from being visible on the Patient Administration interface, which may result in the need for rescans.
Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and mul…
Hazard. Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images from being visible on the Patient Administration interface, which may result in the need for rescans.
Computed Tomography X-ray System, Model: uCT 550 with software
Shanghai United Imaging Healthcare
Updated Aug 1123 units
Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and mul…
Hazard. Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images from being visible on the Patient Administration interface, which may result in the need for rescans.
Computed Tomography X-ray System, Model: uCT 530 with software
Shanghai United Imaging Healthcare
Updated Aug 114 units
Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and mul…
Hazard. Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images from being visible on the Patient Administration interface, which may result in the need for rescans.
Computed Tomography X-ray System, Model: uCT 760 with software
Shanghai United Imaging Healthcare
Updated Aug 111 units
Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and mul…
Hazard. Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images from being visible on the Patient Administration interface, which may result in the need for rescans.
Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and mul…
Hazard. Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images from being visible on the Patient Administration interface, which may result in the need for rescans.
Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and mul…
Hazard. Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images from being visible on the Patient Administration interface, which may result in the need for rescans.
Computed Tomography X-ray System, Model: uCT ATLAS Astound with software
Shanghai United Imaging Healthcare
Updated Aug 1153 units
Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and mul…
Hazard. Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images from being visible on the Patient Administration interface, which may result in the need for rescans.
Baxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSL
Baxter Healthcare
Updated Aug 114 units units
A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty and is replaced while a Volu…
Hazard. A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty and is replaced while a Volume To Be Infused (VTBI) remains.
Microspheres used in embolization of tumors, prostatic arteries, arteriovenous malformations, and blood vessels may have holes in packaging…
Hazard. Microspheres used in embolization of tumors, prostatic arteries, arteriovenous malformations, and blood vessels may have holes in packaging that may affect the sterile barrier, which if used could lead to infection.
Medline Convenience Kits: 1) MAJOR PACK, Catalog Number: DYNJ81325A
Medline Industries, LP
Updated Aug 10128 kits units
The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin lev…
Hazard. The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could require medical intervention, such as neurovascular adverse events, febrile response, and/or local transient inflammation, hypotension, or nausea.
The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin lev…
Hazard. The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could require medical intervention, such as neurovascular adverse events, febrile response, and/or local transient inflammation, hypotension, or nausea.
The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin lev…
Hazard. The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could require medical intervention, such as neurovascular adverse events, febrile response, and/or local transient inflammation, hypotension, or nausea.
Kits contain Healthmark Instrument Channel Brushes, which were recalled by the manufacturer due to the potential for a sharp edge/burr on t…
Hazard. Kits contain Healthmark Instrument Channel Brushes, which were recalled by the manufacturer due to the potential for a sharp edge/burr on the end of the brush. Potential hazards associated include cut injury/abrasion and infection.
The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin lev…
Hazard. The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could require medical intervention, such as neurovascular adverse events, febrile response, and/or local transient inflammation, hypotension, or nausea.
Kits contain Healthmark Instrument Channel Brushes, which were recalled by the manufacturer due to the potential for a sharp edge/burr on t…
Hazard. Kits contain Healthmark Instrument Channel Brushes, which were recalled by the manufacturer due to the potential for a sharp edge/burr on the end of the brush. Potential hazards associated include cut injury/abrasion and infection.
5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6
Fresenius Medical Care Renal Therapies Group
Updated Aug 10120 units units
Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during tre…
Hazard. Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia.
Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234
Philips Ultrasound
Updated Aug 7219 units units
Due to software issue with ultrasound system, doppler sample is displayed shallower than its actual measurement location, potentially causi…
Hazard. Due to software issue with ultrasound system, doppler sample is displayed shallower than its actual measurement location, potentially causing inaccurate blood flow velocity measurements and misdiagnosis.
Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect …
Hazard. Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment.
Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect …
Hazard. Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment.
Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect …
Hazard. Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment.
Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect …
Hazard. Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment.
Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ, 1000 VA
Volcano
Updated Aug 619 systems units
Software system may associate image data from one patient with another patient's record, potentially resulting in incorrect diagnosis or tr…
Hazard. Software system may associate image data from one patient with another patient's record, potentially resulting in incorrect diagnosis or treatment.
ORT300, operating room table, ORT300 Modular Table Main Unit Assy Part Numbers 114093-000…
IMRIS Imaging
Updated Aug 613 units units
The linear actuator and rotational lock mechanism components may experience a mechanical failure that prevents the system from transitionin…
Hazard. The linear actuator and rotational lock mechanism components may experience a mechanical failure that prevents the system from transitioning between locked and unlocked state. This may pose a risk of injury to the patient if unintended rotational movement occurs during a procedure.
ORT200, operating room table, including the ORT200 Covered Table Assembly, Reconditioned…
IMRIS Imaging
Updated Aug 66 units units
The linear actuator and rotational lock mechanism components may experience a mechanical failure that prevents the system from transitionin…
Hazard. The linear actuator and rotational lock mechanism components may experience a mechanical failure that prevents the system from transitioning between locked and unlocked state. This may pose a risk of injury to the patient if unintended rotational movement occurs during a procedure.
LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS…
Boston Scientific
Updated Aug 6N/A units
There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors…
Hazard. There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs). Delayed notification of an AF Burden Alert may delay clinical evaluation or therapeutic intervention of an atrial arrhythmia.
LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS…
Boston Scientific
Updated Aug 6N/A units
There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors…
Hazard. There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs). Delayed notification of an AF Burden Alert may delay clinical evaluation or therapeutic intervention of an atrial arrhythmia.
LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS…
Boston Scientific
Updated Aug 6N/A units
There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors…
Hazard. There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs). Delayed notification of an AF Burden Alert may delay clinical evaluation or therapeutic intervention of an atrial arrhythmia.
When a bolus is included in a treatment plan and sent for secondary dose calculation, the software accounts for it but does not display thi…
Hazard. When a bolus is included in a treatment plan and sent for secondary dose calculation, the software accounts for it but does not display this clearly, which may lead users to incorrectly omit the bolus during treatment and deliver the prescribed dose to the wrong tissue depth.
Brand Name: VOLARA System Product Name: VOLARA, HC, NA A Model/Catalog Number: M08594A…
Baxter Healthcare
Updated Aug 32 units
Contamination within the release test equipment flow path could have affected the accuracy of the nebulizer flow rate. Affected devices ret…
Hazard. Contamination within the release test equipment flow path could have affected the accuracy of the nebulizer flow rate. Affected devices returned to firm and testing confirmed devices meet specifications.
Centricity PACS Server V7, intended for managing digital medical images and associated…
GE Healthcare
Updated Jul 31116 systems units
Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. …
Hazard. Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the wrong patient record, which could lead to misdiagnosis or a delay in patient care.
Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may…
Hazard. Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to contamination of sterile field or patient infection if product is used.
Convenience kits MINOR PACK DYNJ58421A SPRINGHILL MINOR PACK DYNJ40734F
Medline Industries, LP
Updated Jul 31459 units
Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may…
Hazard. Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to contamination of sterile field or patient infection if product is used.
Workflow Core Services V8, intended to provide set of services for storage and retrieval…
GE Healthcare
Updated Jul 31169 systems units
Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. …
Hazard. Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the wrong patient record, which could lead to misdiagnosis or a delay in patient care.
Core Services Hub V8, a set of backend services including Cross Enterprise (XE) and…
GE Healthcare
Updated Jul 31250 systems units
Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. …
Hazard. Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the wrong patient record, which could lead to misdiagnosis or a delay in patient care.
Convenience kits ANESTHESIA PAIN PK LEAGUE DYNJ67925A
Medline Industries, LP
Updated Jul 31341 units
Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may…
Hazard. Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to contamination of sterile field or patient infection if product is used.
Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may…
Hazard. Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to contamination of sterile field or patient infection if product is used.
Aisys CS2, Datex-Ohmeda anesthesia system, Part Number 1011-9055-000
Datex-Ohmeda
Updated Jul 30140 units units
Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alt…
Hazard. Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alternate O2 control, the system delivers 100% O2 to the breathing system enabling continued controlled or manual ventilation and initiates audible and visual alarms. When this issue occurs, anesthetic agent delivery will be interrupted and requires clinician int…
Et Control, Software option for anesthesia gas machine to achieve and maintain targeted…
Datex-Ohmeda
Updated Jul 30410 units units
Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alt…
Hazard. Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alternate O2 control, the system delivers 100% O2 to the breathing system enabling continued controlled or manual ventilation and initiates audible and visual alarms. When this issue occurs, anesthetic agent delivery will be interrupted and requires clinician int…
Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system, Part Number 1011-9000-000
Datex-Ohmeda
Updated Jul 307 units units
Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alt…
Hazard. Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alternate O2 control, the system delivers 100% O2 to the breathing system enabling continued controlled or manual ventilation and initiates audible and visual alarms. When this issue occurs, anesthetic agent delivery will be interrupted and requires clinician int…
Aisys, Datex-Ohmeda anesthesia system, Part Number 1011-9050-000
Datex-Ohmeda
Updated Jul 30475 units units
Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alt…
Hazard. Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alternate O2 control, the system delivers 100% O2 to the breathing system enabling continued controlled or manual ventilation and initiates audible and visual alarms. When this issue occurs, anesthetic agent delivery will be interrupted and requires clinician int…
The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufac…
Hazard. The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is used on a patient, localized skin effects may occur. These may include irritation, erythema, or mild inflammation.
The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufac…
Hazard. The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is used on a patient, localized skin effects may occur. These may include irritation, erythema, or mild inflammation.
The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufac…
Hazard. The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is used on a patient, localized skin effects may occur. These may include irritation, erythema, or mild inflammation.
The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufac…
Hazard. The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is used on a patient, localized skin effects may occur. These may include irritation, erythema, or mild inflammation.
The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufac…
Hazard. The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is used on a patient, localized skin effects may occur. These may include irritation, erythema, or mild inflammation.
The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufac…
Hazard. The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is used on a patient, localized skin effects may occur. These may include irritation, erythema, or mild inflammation.
The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufac…
Hazard. The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is used on a patient, localized skin effects may occur. These may include irritation, erythema, or mild inflammation.
The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufac…
Hazard. The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is used on a patient, localized skin effects may occur. These may include irritation, erythema, or mild inflammation.
The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufac…
Hazard. The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is used on a patient, localized skin effects may occur. These may include irritation, erythema, or mild inflammation.
The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufac…
Hazard. The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is used on a patient, localized skin effects may occur. These may include irritation, erythema, or mild inflammation.
Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide), REF: 5831-9006
restor3d
Updated Jul 272 units
Ankle implantation systems were packaged with incorrect patient-specific cutting guides, which may result in: delayed surgery, the need to …
Hazard. Ankle implantation systems were packaged with incorrect patient-specific cutting guides, which may result in: delayed surgery, the need to use standard instrumentation, reduced fixation or poor alignment of implants, implant loosening/migration, or need for revision surgery.
Medline Convenience Kit: OPEN HEART A PACK, Product Number DYNJ43008N
Medline Industries, LP
Updated Jul 23135 units units
The kits contain a Retrograde Coronary Sinus Perfusion (RCSP) cannulae that has the potential for a sterile barrier breach. Sterility of th…
Hazard. The kits contain a Retrograde Coronary Sinus Perfusion (RCSP) cannulae that has the potential for a sterile barrier breach. Sterility of the product cannot be assured. If a compromised pouch seal is not identified prior to use and the cannula is used, there is a potential risk of infection or other complications associated with the use of a non-sterile device, including hemolysis, foreign body re…
Velys Enabling Tech Robotic-Assist Station REF: 451611001
Medos International Sarl
Updated Jul 2329 stations units
Software issue within robotic controller which may cause unintended movement of the robotic arm during bone preparation or instrument posit…
Hazard. Software issue within robotic controller which may cause unintended movement of the robotic arm during bone preparation or instrument positioning.
Boston Scientific Corporation StoneSmart Connect Console Contents: (1) Power Cord, (1)…
Boston Scientific
Updated Jul 22982 units units
A subset of power adapters used with the connect console may exhibit higher-than-expected resistance in the electrical grounding path. As a…
Hazard. A subset of power adapters used with the connect console may exhibit higher-than-expected resistance in the electrical grounding path. As a result, the power adaptor may fail electrical safety testing during installation.
Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to …
Hazard. Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings previously configured for each patient or care area.
PORTRAIT COMPUTE AND CORE SERVICES V1.2, Ref# 5700592
GE Medical Systems Information Technologies
Updated Jul 204 units units
Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to …
Hazard. Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings previously configured for each patient or care area.
Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to …
Hazard. Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings previously configured for each patient or care area.
Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to …
Hazard. Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings previously configured for each patient or care area.
Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim…
Straumann USA
Updated Jul 16175 units units
Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim may inadvertently contain implants that are 12mm in length inst…
Hazard. Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim may inadvertently contain implants that are 12mm in length instead of 14mm as the labeling would suggest.
Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5 or lower…
Beckman Coulter
Updated Jul 15
a software defect in which the Parameter Package (PP) import logic overwrites all predefined calculated test rules, including those previou…
Hazard. a software defect in which the Parameter Package (PP) import logic overwrites all predefined calculated test rules, including those previously modified by the user, upon import of a new Parameter Package version. As a result, usercustomized calculated test rules revert silently to their default expressions, potentially generating erroneous patient test results without an explicit error notificati…
Beckman Coulter DxC 500 AU Clinical Analyzer Modules using software version 1.5 or lower…
Beckman Coulter
Updated Jul 15
a software defect in which the Parameter Package (PP) import logic overwrites all predefined calculated test rules, including those previou…
Hazard. a software defect in which the Parameter Package (PP) import logic overwrites all predefined calculated test rules, including those previously modified by the user, upon import of a new Parameter Package version. As a result, usercustomized calculated test rules revert silently to their default expressions, potentially generating erroneous patient test results without an explicit error notificati…
Convenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which lacks sterility assurance due to to wrinkles i…
Hazard. Convenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which lacks sterility assurance due to to wrinkles in the paper lidding which may breach the seal area.
Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture …
Hazard. Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result in insulin over- or under-delivery, potentially causing hypoglycemia, hyperglycemia, or diabetic ketoacidosis.
Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture …
Hazard. Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result in insulin over- or under-delivery, potentially causing hypoglycemia, hyperglycemia, or diabetic ketoacidosis.
Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture …
Hazard. Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result in insulin over- or under-delivery, potentially causing hypoglycemia, hyperglycemia, or diabetic ketoacidosis.
Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which may lead to erroneously elevate…
Hazard. Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which may lead to erroneously elevated quinidine measurements, creating risk of sub-optimal patient treatment, including potential life-threatening cardiac arrhythmias or inadequate antimalarial therapy.
Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which may lead to erroneously elevate…
Hazard. Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which may lead to erroneously elevated quinidine measurements, creating risk of sub-optimal patient treatment, including potential life-threatening cardiac arrhythmias or inadequate antimalarial therapy.
There may be a mismatch between the implant contained inside the packaging and the information described on the outer carton label. If the …
Hazard. There may be a mismatch between the implant contained inside the packaging and the information described on the outer carton label. If the the incorrect implant is installed, the issue could cause bone compression or difficulty during installation in situations where there is sufficient bone volume
Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev A, Model/Catalog Number…
Paragon 28
Updated Jul 101 unit units
Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced mate…
Hazard. Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility.
Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model/Catalog Number…
Paragon 28
Updated Jul 101 units
Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced mate…
Hazard. Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility.
The kit component was subjected to EO sterilization, contrary to the manufacturer recommendation, which may have led to the component leaki…
Hazard. The kit component was subjected to EO sterilization, contrary to the manufacturer recommendation, which may have led to the component leaking in a kit.
GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592. patient monitoring system
GE Medical Systems Information Technologies
Updated Jul 1011 units units
A software vulnerability may allow unauthorized persons to gain privileged access to the device, which could result in loss of patient moni…
Hazard. A software vulnerability may allow unauthorized persons to gain privileged access to the device, which could result in loss of patient monitoring, missed patient alarms, and/or access to Protected Health Information (PHI).
Under certain conditions, the battery mounting tabs may become damaged, allowing the battery to move within the device enclosure, potential…
Hazard. Under certain conditions, the battery mounting tabs may become damaged, allowing the battery to move within the device enclosure, potentially leading to an internal short circuit. This may cause localized heating and gas venting within the device enclosure.
Fort Defiance Industries (FDI), Automated Field Steam Sterilizer REF: P2131
Fort Defiance Industries
Updated Jul 8
The Automated Field Steam Sterilizer's water recovery system 120V Amphenol connector may experience an intermittent loss of ground continui…
Hazard. The Automated Field Steam Sterilizer's water recovery system 120V Amphenol connector may experience an intermittent loss of ground continuity, which could result in an unreliable fault current return path.
Under certain conditions, the battery mounting tabs may become damaged, allowing the battery to move within the device enclosure, potential…
Hazard. Under certain conditions, the battery mounting tabs may become damaged, allowing the battery to move within the device enclosure, potentially leading to an internal short circuit. This may cause localized heating and gas venting within the device enclosure.
Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled …
Hazard. Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential out-of-specification levels of endotoxin of the neurosponges.
Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled …
Hazard. Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential out-of-specification levels of endotoxin of the neurosponges.
The affected Endo-Model replacement set for a Rotating Hinge tibial plateau incorrectly contains a Pure Hinge plateau. The incorrect platea…
Hazard. The affected Endo-Model replacement set for a Rotating Hinge tibial plateau incorrectly contains a Pure Hinge plateau. The incorrect plateau could lead to a prolonged or modified surgery as the plateau cannot be inserted and an alternative product would be needed. If the incorrect plateau were to be implanted, this is associated with increased risk of wear, which could result in a reduced standin…
Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection…
Spectra Medical Devices
Updated Jul 6TBD units
Manufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance. If the product sterility is compromised,…
Hazard. Manufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance. If the product sterility is compromised, patients may be exposed to microorganisms, endotoxins, or foreign matter. This may trigger inflammatory responses, infections, micro-clots, and organ failure.
OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095. Ballast, 45 x 17.5 mm (IsoTis…
IsoTis OrthoBiologics
Updated Jul 298 units
Demineralized bone matrix (DBM) in resorbable mesh indicated for use with autograft as a bone graft extender in the posterolateral spine an…
Hazard. Demineralized bone matrix (DBM) in resorbable mesh indicated for use with autograft as a bone graft extender in the posterolateral spine and pelvis, were filled with approx. 4.5 cc DBM (fill for 45 ¿ 11 mm configuration) instead of approx. 7.5 cc DBM (fill for 45 ¿ 17.5 mm configuration), which may lead to delayed fusion, incomplete fusion, pseudarthrosis, or lack of bone ingrowth.
Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475640 Product Description…
Biomet
Updated Jul 111 units
Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potentia…
Hazard. Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.
Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475635 Product Description…
Biomet
Updated Jul 122 units
Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potentia…
Hazard. Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.
Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475620 Product Description…
Biomet
Updated Jul 110 units
Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potentia…
Hazard. Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.
Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475625 Product Description…
Biomet
Updated Jul 112 units
Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potentia…
Hazard. Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.
5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905
Aniara Diagnostica
Updated Jul 14 units units
Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead t…
Hazard. Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degradation of measurable bivalirudin in the controls, calibrators, and linearity values.
5-PLASMA Bivalirudin Control, Model Number 5D-44905
Aniara Diagnostica
Updated Jul 19 units units
Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead t…
Hazard. Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degradation of measurable bivalirudin in the controls, calibrators, and linearity values.
5-PLASMA Bivalirudin Calibrator, Model Number 5D-46905
Aniara Diagnostica
Updated Jul 17 units units
Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead t…
Hazard. Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degradation of measurable bivalirudin in the controls, calibrators, and linearity values.
Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475630 Product Description…
Biomet
Updated Jul 126 units
Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potentia…
Hazard. Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.
SnapshotGLO Wound Imaging Device, Model KB100, KB100AA.
KENT IMAGING
Updated Jun 3077 units
The software controlling the wound imaging device's battery charging circuit was not designed to recognize and recover a battery that has f…
Hazard. The software controlling the wound imaging device's battery charging circuit was not designed to recognize and recover a battery that has fully discharged into a low-power "shipping mode." When this occurs, an affected device will not resume charging when reconnected to power and becomes temporarily unusable/ unavailable for wound imaging until corrected.
American Contract System Convenience Kit, D & C PACK, Model/Catalog Number: LLPD90H
American Contract Systems
Updated Jun 2912 units units
The Convenience Kits contain Medline's Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline In…
Hazard. The Convenience Kits contain Medline's Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has identified representative samples did not meet applicable performance specifications.
American Contract System Convenience Kits, CV B PACK, Model/Catalog Number: TNCB10AP
American Contract Systems
Updated Jun 2930 units units
The Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline In…
Hazard. The Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has identified representative samples did not meet applicable performance specifications.
American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AM
American Contract Systems
Updated Jun 2930 units units
The Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline In…
Hazard. The Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has identified representative samples did not meet applicable performance specifications.
American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AN
American Contract Systems
Updated Jun 2930 units units
The Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline In…
Hazard. The Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has identified representative samples did not meet applicable performance specifications.
GE Healthcare MAC VU360, REF# part number 2030361-023; Electrocardiograph
GE Medical Systems Information Technologies
Updated Jun 29163 units units
Software issue issue with the MAC VU360 v3.0 system. After selecting the order refresh icon, an open preview or review screen might fail to…
Hazard. Software issue issue with the MAC VU360 v3.0 system. After selecting the order refresh icon, an open preview or review screen might fail to close automatically after 2 minutes of inactivity. As a result, data from a previous patient may remain on the screen and could be incorrectly associated with a subsequent patient.
Out-of-specification sodium azide concentration in Syva Emit Disopyramide Enzyme Immunoassay Calibrator Lot U1. While the assay results wer…
Hazard. Out-of-specification sodium azide concentration in Syva Emit Disopyramide Enzyme Immunoassay Calibrator Lot U1. While the assay results were not impacted, the overall health risk to lab technicians due to this issue is low, as exposure is limited by small volumes and a 0.2% post-reconstitution sodium azide concentration, with the worst outcome being mild skin or eye irritation and no serious harm…
Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifi…
Hazard. Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications."
REF # D23354, MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US) on the following…
Beckman Coulter
Updated Jun 26
Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifi…
Hazard. Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications."
Products that contain the Pericare Wipes: (Canada Only) SureStep" Foley Tray System…
C.R. Bard
Updated Jun 25364 units
Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermitte…
Hazard. Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001…
Boston Scientific
Updated Jun 1968 units units
Software anomaly occurs when a user adds one or more vials to the cart and subsequently returns to the Activity Calculator to modify one or…
Hazard. Software anomaly occurs when a user adds one or more vials to the cart and subsequently returns to the Activity Calculator to modify one or more input. When a user modifies an input and selects "Recalculate", the dose calculation is updated correctly; however, any vials that were previously added to the cart are not automatically updated to reflect the revised calculation.
Power F2 Powered Fastening System, Product No. 0567091 Powered fastening system intended…
Ferno-Washington
Updated Jun 19278 units
Product may experience accelerated roller wear and potential deformation due to interference between the roller assembly and rail. In the w…
Hazard. Product may experience accelerated roller wear and potential deformation due to interference between the roller assembly and rail. In the worst-case condition, rail mechanism may become lodged during operation and movement of the stretcher along the rail may no longer be possible through either powered or manual operation. May cause delays in transport of patient to healthcare facility.
Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LF
Freudenberg Medical
Updated Jun 1740 units units
Incorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal and Tracheal Flange, and the labeled box fo…
Hazard. Incorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal and Tracheal Flange, and the labeled box for the Large Esophageal and Tracheal Flange contains a Large Esophageal Flange.
Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LEF
Freudenberg Medical
Updated Jun 1712 units units
Incorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal and Tracheal Flange, and the labeled box fo…
Hazard. Incorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal and Tracheal Flange, and the labeled box for the Large Esophageal and Tracheal Flange contains a Large Esophageal Flange.
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Block Tray - RX, Part…
Windstone Medical Packaging
Updated Jun 17100 kits units
Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing …
Hazard. Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplier quality issues.
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Heart Cath Tray - RX…
Windstone Medical Packaging
Updated Jun 1724 kits units
Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing …
Hazard. Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplier quality issues.
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Port Tray - RX, Part…
Windstone Medical Packaging
Updated Jun 1715 kits units
Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing …
Hazard. Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplier quality issues.
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Nerve Block Tray…
Windstone Medical Packaging
Updated Jun 17950 kits units
Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing …
Hazard. Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplier quality issues.
Ventriculostomy devices, used during ventriculostomy procedures to gain access to the ventricular system, may exhibit endotoxin levels that…
Hazard. Ventriculostomy devices, used during ventriculostomy procedures to gain access to the ventricular system, may exhibit endotoxin levels that exceed the acceptable limit for devices that come into contact with cerebrospinal fluid; endotoxin exposure can cause an acute inflammatory process.
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Angio Pack - RX, Part…
Windstone Medical Packaging
Updated Jun 1760 kits units
Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing …
Hazard. Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplier quality issues.
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Dr Fred Chiu Single…
Windstone Medical Packaging
Updated Jun 17580 kits units
Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing …
Hazard. Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplier quality issues.
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: SPINAL KIT, Part…
Windstone Medical Packaging
Updated Jun 1715 kits units
Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing …
Hazard. Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplier quality issues.
Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life o…
Hazard. Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.
Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life o…
Hazard. Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.
Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life o…
Hazard. Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.
Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life o…
Hazard. Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.
Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life o…
Hazard. Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.
Catheters, indicated for short/long-term peripheral access to central venous system for the administration of fluids, medications, nutrient…
Hazard. Catheters, indicated for short/long-term peripheral access to central venous system for the administration of fluids, medications, nutrients; and sampling, may experience leaking and/or cracking at the hub, which may lead to replacement, inability to flush/aspirate catheter, catheter occlusion, therapy interruption, blood loss, tissue irritation, bloodstream infection.
Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life o…
Hazard. Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.
Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life o…
Hazard. Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.
Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life o…
Hazard. Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.
Medline Convenience Kits: 1) COLORECTAL ME, Model Number: DYNJ906437D
Medline Industries, LP
Updated Jun 12176 kits units
The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging,…
Hazard. The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less com…
The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging,…
Hazard. The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less com…
Medline Convenience Kits: 1) C-SECTION PREP, Model Number: DYNJ32702B
Medline Industries, LP
Updated Jun 12352 kits units
The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging,…
Hazard. The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less com…
Medline Convenience Kits: 1) ULTRASOUND BREAST PACK, Model Number: DYNJ63375C
Medline Industries, LP
Updated Jun 12300 kits units
The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging,…
Hazard. The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less com…
ST AIA-Pack Testosterone, IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement…
Tosoh Bioscience
Updated Jun 12310 units units
The Test cup lot F level 1 low-quality control results values for the device were lower than expected on the Automated Immunoassay Analyzer…
Hazard. The Test cup lot F level 1 low-quality control results values for the device were lower than expected on the Automated Immunoassay Analyzer (AIA) which could cause falsely elevated or falsely low total testosterone results. Such erroneous test results may lead to additional testing/diagnostic interventions and in limited cases, may lead to a delay in diagnosis and/or initiation of unnecessary or …
The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tr…
Hazard. The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occur. This may result in the clinical acquisition being inadequate for diagnosis, causing a potential for patient rescan and receiving additional radiation.
ABIOMED Impella CP Introducer Kit 14 Fr, 13 and 25 cm, Pump Set Code 1000550, containing…
Abiomed
Updated Jun 11846 units units
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers.…
Hazard. A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
FARADRIVE Steerable Sheath Clear IDE, used to facilitate access to the vasculature and…
Boston Scientific
Updated Jun 11400 units units
Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve d…
Hazard. Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve damage may result in air ingress, potential air embolism, and associated patient harm. This risk can be mitigated by inserting the dilator straight through the center of the valve …
Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with…
Hazard. Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species.
Medline medical convenience kits labeled as: 1) KIT PEDIATRIC OPEN HEART MOSES, Medline…
Medline Industries, LP
Updated Jun 11155 kits units
Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with…
Hazard. Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species.
Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with…
Hazard. Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species.
FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401…
Boston Scientific
Updated Jun 116 units units
Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOIN…
Hazard. Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter.
Ingenuity CT CT5000 Ingenuity Plus CT5000 Ingenuity Pro CT5000 Ingenuity Premium…
PHILIPS MEDICAL SYSTEMS
Updated Jun 11182 units
The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tr…
Hazard. The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occur. This may result in the clinical acquisition being inadequate for diagnosis, causing a potential for patient rescan and receiving additional radiation.
The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tr…
Hazard. The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occur. This may result in the clinical acquisition being inadequate for diagnosis, causing a potential for patient rescan and receiving additional radiation.
ABIOMED Introducer Kit 23 Fr, 11 cm, Pump Set Code 1000441, containing Kit, 23Fr…
Abiomed
Updated Jun 11196 units units
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers.…
Hazard. A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
ABIOMED Intro Kit, 14Fr x 13 and 25 cm, PKGD, JP, Pump Set Code 0052-0023-JP; containing…
Abiomed
Updated Jun 1196 units units
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers.…
Hazard. A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers.…
Hazard. A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers.…
Hazard. A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers.…
Hazard. A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral…
Orthofix U.S.
Updated Jun 1048 units units
Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and …
Hazard. Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111
Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK-LF…
Medline Industries, LP
Updated Jun 10163 kits units
Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which present risk of sterility breac…
Hazard. Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which present risk of sterility breach. Health consequences from use of product include clinically insignificant extension of surgery to find another readily available device.
Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and …
Hazard. Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111
Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and …
Hazard. Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111
Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK DYNJT6267
Medline Industries, LP
Updated Jun 10163 kits units
Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which present risk of sterility breac…
Hazard. Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which present risk of sterility breach. Health consequences from use of product include clinically insignificant extension of surgery to find another readily available device.
Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and …
Hazard. Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111
Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, …
Hazard. Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region.
Due to incorrect cartridges include in affected products that there is the potential for false-susceptible or false-resistant susceptibilit…
Hazard. Due to incorrect cartridges include in affected products that there is the potential for false-susceptible or false-resistant susceptibility results and may lead to selection of an ineffective antimicrobial therapy, potentially resulting in delayed appropriate treatment, prolonged infection, or worsening clinical outcome.
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Neuro Pack, Pack…
Windstone Medical Packaging
Updated Jun 8927 units units
The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological S…
Hazard. The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products.
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT Pack, Pack…
Windstone Medical Packaging
Updated Jun 8919 units units
The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological S…
Hazard. The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products.
Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw materi…
Hazard. Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.
Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw materi…
Hazard. Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.
MEDLINE medical procedure convenience kit labeled as: HIP CDS-LF, Medline kit SKU…
Medline Industries, LP
Updated Jun 852 kits units
The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in Dextrose Injection, USP, which we…
Hazard. The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in Dextrose Injection, USP, which were recalled due to quality issues that could result in drug ineffectiveness.
Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw materi…
Hazard. Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.
Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 12 mm 027 REF…
Micro Therapeutics
Updated Jun 813 units units
Incorrect labeling - embolization devices labeled as 3.0 mm x 20 mm implants contain 12 mm implants, and devices labeled as 3.0 mm x 12 mm …
Hazard. Incorrect labeling - embolization devices labeled as 3.0 mm x 20 mm implants contain 12 mm implants, and devices labeled as 3.0 mm x 12 mm implants contain 20 mm implants.
Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw materi…
Hazard. Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.
Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw materi…
Hazard. Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.
Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw materi…
Hazard. Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.
Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 20 mm 027 REF…
Micro Therapeutics
Updated Jun 86 units units
Incorrect labeling - embolization devices labeled as 3.0 mm x 20 mm implants contain 12 mm implants, and devices labeled as 3.0 mm x 12 mm …
Hazard. Incorrect labeling - embolization devices labeled as 3.0 mm x 20 mm implants contain 12 mm implants, and devices labeled as 3.0 mm x 12 mm implants contain 20 mm implants.
Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw materi…
Hazard. Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.
Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw materi…
Hazard. Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.
Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw materi…
Hazard. Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.
MEDLINE medical procedure convenience kit labeled as: 1) TOTAL KNEE-LF, Medline kit SKU…
Medline Industries, LP
Updated Jun 8318 kits units
The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in Dextrose Injection, USP, which we…
Hazard. The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in Dextrose Injection, USP, which were recalled due to quality issues that could result in drug ineffectiveness.
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT Pack, Part…
Windstone Medical Packaging
Updated Jun 8465 units units
The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological S…
Hazard. The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products.
Potential issue with the Display ceiling suspension (DCS Fix XL) that holds the monitor in place. Over time some screws that keep the monit…
Hazard. Potential issue with the Display ceiling suspension (DCS Fix XL) that holds the monitor in place. Over time some screws that keep the monitor attached to the suspension may gradually loosen.
Optima XR200amx, Mobile Digital-Ready Radiographic System
GE Medical Systems
Updated Jun 54 units units
GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional tes…
Hazard. GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly. If a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work, causing the arm with X-ray tube and collimator to drop downward on the column tra…
Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochl…
Hazard. Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochloride in Dextrose Injection, USP. B. Braun Medical Inc. was notified by their supplier, Spectra Medical Devices, LLC of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. Huons Co, Ltd. has issued a …
Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochl…
Hazard. Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochloride in Dextrose Injection, USP. B. Braun Medical Inc. was notified by their supplier, Spectra Medical Devices, LLC of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. Huons Co, Ltd. has issued a …
Optima XR240amx, Mobile Digital Radiographic System
GE Medical Systems
Updated Jun 524 units units
GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional tes…
Hazard. GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly. If a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work, causing the arm with X-ray tube and collimator to drop downward on the column tra…
Optima XR220amx, Mobile Digital-Ready Radiographic System
GE Medical Systems
Updated Jun 538 units units
GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional tes…
Hazard. GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly. If a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work, causing the arm with X-ray tube and collimator to drop downward on the column tra…
OmniTract Surgical Retractor System, which includes 633 of the firm s product codes.
Integra LifeSciences (NeuroSciences)
Updated Jun 5633 units units
The current Omni-Tract Surgical Retractor System IFU states a dry time of 30 minutes. Integra LifeSciences has identified that the dry time…
Hazard. The current Omni-Tract Surgical Retractor System IFU states a dry time of 30 minutes. Integra LifeSciences has identified that the dry time needs to be extended to 90 minutes, 110 minutes, or 120 minutes depending on the sterilization cycle exposure time used.
Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the following…
Philips North America
Updated Jun 5909 units units
Potential for device reset to default "NEW_DEVICE" state, which may lead to a to loss of device configuration and the equipment label, resu…
Hazard. Potential for device reset to default "NEW_DEVICE" state, which may lead to a to loss of device configuration and the equipment label, resulting in a failure to reconnect to the PIC iX central monitoring system.
The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System (Model VH-4000; UDI…
Maquet Cardiovascular
Updated Jun 2205 units units
Getinge identified that Vasoview Hemopro 2 devices from Lot 3000547797 were exposed to an out-of-specification sterilization dose during a …
Hazard. Getinge identified that Vasoview Hemopro 2 devices from Lot 3000547797 were exposed to an out-of-specification sterilization dose during a gamma sterilization run (Run ID 1183-28782A) performed by STERIS at its Whippany, NJ facility between March 31 and April 1 of 2026.
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria f…
Hazard. Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
T-Lok Bone Marrow Tray, REF: BMT1104STL; BMET1104TL; BMT1104CATL
Argon Medical Devices
Updated Jun 1850 units
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria f…
Hazard. Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria f…
Hazard. Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria f…
Hazard. Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria f…
Hazard. Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
Emano Flow with software version v2.0.0 GS1 GTIN code: 199874903484 Emano Flow is a…
Emano Metrics
Updated May 29685 units
Problem description/Reason for recall: During the period March 22, 2026, to May 29, 2026, recorded urination audio was captured at 48,000 H…
Hazard. Problem description/Reason for recall: During the period March 22, 2026, to May 29, 2026, recorded urination audio was captured at 48,000 Hz while the model was trained and validated on 44,100 Hz audio. The models depend on the sampling so every recording in the window was therefore processed against a time/frequency scale the models did not expect, producing systematically biased Qmax, Qmean, an…
Medline Convenience Kits: 1) OPEN HEART PEDS PACK, Model Number: DYNJ88569D; 2) ACCESSORY…
Medline Industries, LP
Updated May 2875 kits units
Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medtronic has issued a recall of specific produ…
Hazard. Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medtronic has issued a recall of specific production lots of the Covidien Mon-a-Therm general purpose temperature probe-size 9 due to an error in its distribution control process.
Medline Convenience Kits: 1) OPEN HEART PEDS PACK, Model Number: DYNJ88569; 2) OPEN HEART…
Medline Industries, LP
Updated May 28396 kits units
Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medtronic has issued a recall of specific produ…
Hazard. Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medtronic has issued a recall of specific production lots of the Covidien Mon-a-Therm general purpose temperature probe-size 9 due to an error in its distribution control process.
A software anomaly can occur when the pump is paired with the Instinct sensor. Under certain circumstances, the pump unexpectedly stops del…
Hazard. A software anomaly can occur when the pump is paired with the Instinct sensor. Under certain circumstances, the pump unexpectedly stops delivering insulin and displays two error messages back-to-back: Pump Error 53 followed immediately by Pump Error 23. Insulin delivery will stop which may lead to delayed therapy and an increased risk of hyperglycemia or diabetic ketoacidosis (DKA).
Certain lots of Dexcom G7 sensors originally designated as scrap and intended for destruction were stolen during the destruction process. T…
Hazard. Certain lots of Dexcom G7 sensors originally designated as scrap and intended for destruction were stolen during the destruction process. The sensors were later sold to pharmacies and distributors by Pharmsource, LLC. Lot 1725204004 were designated for destruction because the G7 sensors were not properly sterilized and have an increased risk of skin infection if used. Lot 1725069002 were designat…
Advance Aluminum Chloride Gel Clear Hemostatic Gel Kit, Catalog number 504600-28
Inter-Med
Updated May 27500 units
Some units of Aluminum Chloride Gel contain the package insert for Ferric Sulfate Gel. The incorrect insert misidentifies the product and c…
Hazard. Some units of Aluminum Chloride Gel contain the package insert for Ferric Sulfate Gel. The incorrect insert misidentifies the product and contains different first aid instructions, most critically in that the Ferric Sulfate insert instructs users to induce vomiting in the case of ingestion, while the correct Aluminum Chloride insert instructs users not to induce vomiting.
Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A
Philips North America
Updated May 26285 units units
Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk…
Hazard. Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of speaker output.
Philips Avalon Fetal Monitor, FM 30 Part numberM2703A
Philips North America
Updated May 26169 units units
Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk…
Hazard. Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of speaker output.
GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1010. Flexible…
W L Gore & Associates
Updated May 2213 units units
10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without trans…
Hazard. 10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes (VSWVN1010).
Anti-Torque, Vector, Part: LS-749 part of Vector Pedicle Screw System
Innovasis
Updated May 225 units
Pedicle screw system intended to provide immobilization/stabilization of spinal segments as adjunct to thoracic/lumbar/sacral spine fusion …
Hazard. Pedicle screw system intended to provide immobilization/stabilization of spinal segments as adjunct to thoracic/lumbar/sacral spine fusion may have anti-torque instrument with undersized condition which could prevent mating tip from engaging with the pedicle screw tulip and rod during tightening, which may lead to surgical delay, intervention/alternative methods to perform final tightening step.
GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1006. Flexible…
W L Gore & Associates
Updated May 2213 units units
10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without trans…
Hazard. 10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes (VSWVN1010).
Due to reported complaints, the cuff device may alarm with a "Cuff System Leakage" error. As a result, the motor may pump continuously and …
Hazard. Due to reported complaints, the cuff device may alarm with a "Cuff System Leakage" error. As a result, the motor may pump continuously and fail to maintain the cuff pressure set by the user.
GEM Premier 7000 with iQM3 Part Numbers: 00077407508 00077407510 00077415004 00077415008…
Instrumentation Laboratory
Updated May 2132 units units
The active ingredient concentration in the lysing bag solution of specific GEM Premier 7000 with iQM3 PAK lots did not meet established man…
Hazard. The active ingredient concentration in the lysing bag solution of specific GEM Premier 7000 with iQM3 PAK lots did not meet established manufacturing specifications. The malfunction could result in delayed recognition and management of Co-Oximetry and total bilirubin abnormalities and their sequelae.
GEM Premier 5000 PAK Part Numbers: 00055360010 00055360011 00055407504 00055415010…
Instrumentation Laboratory
Updated May 21109 units units
The active ingredient concentration in the lysing bag solution of specific GEM Premier 5000 lots did not meet established manufacturing spe…
Hazard. The active ingredient concentration in the lysing bag solution of specific GEM Premier 5000 lots did not meet established manufacturing specifications. The malfunction could result in delayed recognition and management of Co-Oximetry and total bilirubin abnormalities and their sequelae.
Flexible Hystero-Fiberscope Kits REF: 11264BBU1, 11264BBUK1, that contain expired Single…
Karl Storz Endoscopy
Updated May 2145 units
Flexible hysteroscopes indicated for use during diagnostic and operative hysteroscopic procedures may contain an expired single use endosco…
Hazard. Flexible hysteroscopes indicated for use during diagnostic and operative hysteroscopic procedures may contain an expired single use endoscopic seal for gynecology use, which could impact the assurance of sterility.
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently bein…
Hazard. Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Medline Convenience Kits: 1) DYNJ0621189X, Model Number: SM RADIOLOGY-ANGIO PACK-LF; 2)…
Medline Industries, LP
Updated May 21333 kits units
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons …
Hazard. The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently bein…
Hazard. Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Medline Convenience Kits: 1) SUTURING SET, Model Number: SUT13710
Medline Industries, LP
Updated May 21176 kits units
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons …
Hazard. The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons …
Hazard. The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons …
Hazard. The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently bein…
Hazard. Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
A M S, ALIGNED MEDICAL SOLUTIONS, Preop Kit-NS, Pack Number AMS18227, surgical…
Windstone Medical Packaging
Updated May 21200 units units
Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus p…
Hazard. Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
Solar GI System (Water Perfusion); Product Name (Catalog Number): Solar GI LGI H2O, 12p…
Laborie Medical Technologies
Updated May 21372 units units
Under extended clinical use conditions (e.g., long duration studies), moisture generated within the pneumatic circuit may accumulate inside…
Hazard. Under extended clinical use conditions (e.g., long duration studies), moisture generated within the pneumatic circuit may accumulate inside the system's internal tubing or at the hydrophobic filter and waterproof pressure sensors. Accumulated moisture may affect airflow or pressure measurement performance if not properly removed.
Medline Convenience Kits: 1) MERCY MEDICAL CIRCUMCISION TRAY, Model Number: CIT6780; 2)…
Medline Industries, LP
Updated May 21512 kits units
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons …
Hazard. The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.
Medline Convenience Kits: 1) ARTERIAL LINE KIT, Model Number: ART890B; 2) ULTRASOUND…
Medline Industries, LP
Updated May 21250 kits units
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons …
Hazard. The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.
Medline Convenience Kits: 1) OPHTHALMIC PACK W/LIDO, Model Number: DYNJ57922A
Medline Industries, LP
Updated May 21180 kits units
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons …
Hazard. The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently bein…
Hazard. Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
A M S, ALIGNED MEDICAL SOLUTIONS, Thyroid FNA Pack-RX, Pack Number AMS17729, surgical…
Windstone Medical Packaging
Updated May 21200 units units
Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus p…
Hazard. Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
A M S, ALIGNED MEDICAL SOLUTIONS, Dr. Lewin Pack, Pack Number AMS7200D, surgical…
Windstone Medical Packaging
Updated May 2145 units units
Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus p…
Hazard. Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
Medline Convenience Kits: 1) BLOCK TRAY, Model Number: DYNJRA1590
Medline Industries, LP
Updated May 21270 kits units
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons …
Hazard. The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.
Medline Convenience Kits: 1) LUMBAR PUNCTURE CHOICE, Model Number: DYNDH1215
Medline Industries, LP
Updated May 21420 kits units
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons …
Hazard. The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently bein…
Hazard. Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Hillrom VOLARA P.CIRCUIT 5KIT (System Single Patient Use Circuit), Model/Catalog Number…
Baxter Healthcare
Updated May 21
There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage …
Hazard. There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the delivery of the prescribed treatment. The issue has been associated with improper locking of the nebulizer cup after adding medication during user setup.
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons …
Hazard. The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons …
Hazard. The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.
Beam set delivery note issues in which there is potential data loss if the beam set delivery note is modified simultaneously and/or if a no…
Hazard. Beam set delivery note issues in which there is potential data loss if the beam set delivery note is modified simultaneously and/or if a note is updated during a treatment session, the user is not notified of the change.
Beam set delivery note issues in which there is potential data loss if the beam set delivery note is modified simultaneously and/or if a no…
Hazard. Beam set delivery note issues in which there is potential data loss if the beam set delivery note is modified simultaneously and/or if a note is updated during a treatment session, the user is not notified of the change.
The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological S…
Hazard. The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products.
American Contract Systems medical procedure kits and trays labeled as: 1) ANTERIOR…
American Contract Systems
Updated May 19160 kits units
The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological S…
Hazard. The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products.
Halyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01. Convenience kit.
AVID Medical
Updated May 19112 kits units
Defects in the silicone seal, which may result in "doming" of the silicone seal due to improper sealing, potentially leading to fluid occlu…
Hazard. Defects in the silicone seal, which may result in "doming" of the silicone seal due to improper sealing, potentially leading to fluid occlusion or leakage.
ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System.
Bioporto Diagnostics A/S
Updated May 18400 units units
The use of a non-validated rework process for assay reagents which could lead to missed diagnosis of renal disease, inappropriate treatment…
Hazard. The use of a non-validated rework process for assay reagents which could lead to missed diagnosis of renal disease, inappropriate treatment decisions, or inappropriate monitoring of renal disease in intended users.
Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.
Abiomed
Updated May 1810 units units
Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in some cases, interruption or loss o…
Hazard. Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in some cases, interruption or loss of mechanical circulatory support.
Reprocessed Electrophysiology Catheters and Ultrasound Catheters Item no. 401206RH, St…
Medline Industries, LP
Updated May 153 units
Expansion of RES 98277. Specific lots of reprocessed catheters may contain small particles of residual material. If devices with residual p…
Hazard. Expansion of RES 98277. Specific lots of reprocessed catheters may contain small particles of residual material. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection. If particulate were to dislodge during use and contact circulating blood or the heart, it may produce a granulomatous reaction or …
SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System
Alphatec Spine
Updated May 133 units
Intraoperative neuromonitoring device, due to a software issue, may experience loss or interruption of triggered electromyography (tEMG) fu…
Hazard. Intraoperative neuromonitoring device, due to a software issue, may experience loss or interruption of triggered electromyography (tEMG) functionality during use, displaying as system faults, loss of communication between the Patient Interface and Tablet, and prompts requiring system reboot; may result in increased operative time and surgical plan change.
Cardiovascular procedure kits contain manifolds, the subject of another recall, that may have particulate within the fluid path, which has …
Hazard. Cardiovascular procedure kits contain manifolds, the subject of another recall, that may have particulate within the fluid path, which has the potential to be introduced into blood circulation and become lodged within blood vessels.
During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short t…
Hazard. During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.
During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short t…
Hazard. During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.
Octopus Evolution AS Tissue Stabilizer, Model TS2500
Medtronic Perfusion Systems
Updated May 12288 units units
During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short t…
Hazard. During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.
Device not certified - no laser product report was filed with CDRH prior to distribution. Product label incorrectly states device is "Class…
Hazard. Device not certified - no laser product report was filed with CDRH prior to distribution. Product label incorrectly states device is "Class IV", although Class 1 is appropriate for device. Improperly labeled - omitted labels required under 21 CFR 1040.10 / IEC 60825-1 via LN#56. Missing certification and proper manufacturer's ID label. Was not accompanied by compliant User Information. Formalized…
Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire stimulation Lead…
Inspire Medical Systems
Updated May 1110 impacted units units
Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf life from date of manufacturer. Material d…
Hazard. Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf life from date of manufacturer. Material degradation of a product past its Use By Date may result in unplanned or premature revision surgery.
Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire Respiratory Sensing Lead…
Inspire Medical Systems
Updated May 1150 impacted units units
Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf life from date of manufacturer. Material d…
Hazard. Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf life from date of manufacturer. Material degradation of a product past its Use By Date may result in unplanned or premature revision surgery.
Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number…
Instrumentation Laboratory
Updated May 867 units
Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an inc…
Hazard. Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID.
Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number…
Instrumentation Laboratory
Updated May 827 units
Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an inc…
Hazard. Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID.
Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number…
Instrumentation Laboratory
Updated May 821 units
Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an inc…
Hazard. Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID.
Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number…
Instrumentation Laboratory
Updated May 83 units
Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an inc…
Hazard. Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID.
GEM Premier 5000 with IQM2 Model/Catalog Number: 00024019255 and GEM Premier 7000 with…
Instrumentation Laboratory
Updated May 8122 units
Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an inc…
Hazard. Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID.
Brand Name: GEM Premier 7000 with iQM3 Product Name: GEM Premier 7000 with iQM3…
Instrumentation Laboratory
Updated May 84 US units
Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an inc…
Hazard. Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID.
VOCSN+Pro package, REF: PRT-00853-000; VOCSN+Pro unit, REF: PRT-00490-001
Ventec Life Systems
Updated May 81 units
Respiratory system intended to provide continuous/intermittent ventilator support, may have a damaged back-up battery supporting backup ala…
Hazard. Respiratory system intended to provide continuous/intermittent ventilator support, may have a damaged back-up battery supporting backup alarm function, which may result in the backup alarm not activating during loss of primary power and absence/depletion of backup power sources, which may result in delayed caregiver awareness of a hazardous condition.
GE Healthcare AW Server 3.2 ext.6.5; Radiological Image Processing System
GE Medical Systems SCS
Updated May 8340 servers units
GE HealthCare has become aware of a context synchronization issue in AW Server 3.2 ext. 6.5. When a user selects a patient or exam in the A…
Hazard. GE HealthCare has become aware of a context synchronization issue in AW Server 3.2 ext. 6.5. When a user selects a patient or exam in the AW Server Web Client worklist and launches an interactive application (e.g. Volume Viewer), the application may open the previous patient's exam instead of the intended one. When this issue occurs, there is no system warning or error notification. If the error …
User measurement value reported by diagnostic bioimaging software intended to measure/visualize cardiovascular structures may be larger (0.…
Hazard. User measurement value reported by diagnostic bioimaging software intended to measure/visualize cardiovascular structures may be larger (0.8% to 34.4%) than the actual anatomical dimension, if all the following occur: affected software is used, and the user has access only to 3D Echo OR Mitral 3D Echo, and the dataset being analyzed is a Philips 3D echo dataset containing Color Doppler information
Atlan A350XL. Model Number: 8621600. anesthesia workstation
Draeger
Updated May 7394 units units
The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ven…
Hazard. The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
Medline Convenience Kits: 1) DRAWER 6 CENTRAL LINE INSERTIO, Model Number: ACC011142; 2)…
Medline Industries, LP
Updated May 6233 units units
The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride …
Hazard. The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were recalled due to quality issues identified during a recent FDA inspection of the supplier.
Medline Convenience Kits: 1) DRAWER 6A ADULT CENTRAL LINE, Model Number: ACC010890; 2)…
Medline Industries, LP
Updated May 6503 units units
The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride …
Hazard. The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were recalled due to quality issues identified during a recent FDA inspection of the supplier.