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.
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.
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…
Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 Catheters for use…
Cook
Updated Apr 211,253 units
Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, …
Hazard. Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may cause life-threatening harm or death.
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: *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.
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.
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…
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.
These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huon Co, Ltd., has …
Hazard. These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huon Co, Ltd., has issued a voluntary recall due to potential quality issues identified during a recent FDA manufacturing facility inspection.
These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huon Co, Ltd., has …
Hazard. These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huon Co, Ltd., has issued a voluntary recall due to potential quality issues identified during a recent FDA manufacturing facility inspection.
MEDLINE Medical Procedure Kits labeled as CH OPEN HEART, ADULT CARDIAC KIT, AHT CVOR…
Medline Industries, LP
Updated May 4168968 units units
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues …
Hazard. During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
MEDLINE Medical Procedure Kits labeled as BIOBURDEN TEST KIT, Kit Uro Robot Cystectomy…
Medline Industries, LP
Updated May 4123030 units units
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues …
Hazard. During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
MEDLINE Pre-connected Urethral Catheterization Tray and Bag, Red Rubber Latex, 15 Fr…
Medline Industries, LP
Updated May 44304669 units units
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues …
Hazard. During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
MEDLINE Urethral Catheterization Tray, Red Rubber Latex, Medline Product Number/SKU…
Medline Industries, LP
Updated May 48327756 units units
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues …
Hazard. During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
MEDLINE Urethral Catheterization Tray and Bag, Red Rubber Latex, 15 Fr, Medline Product…
Medline Industries, LP
Updated May 4235658 units units
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues …
Hazard. During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues …
Hazard. During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in performance as they age, particularly beyo…
Hazard. It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in performance as they age, particularly beyond six years of service. Issues with an HDD may, depending on the specific system PC in which the affected HDD is installed, result in loss of imaging functionality. Additionally, in Allura systems, this may lead to loss of motorized movement, or loss of data.…
The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potent…
Hazard. The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the cooling performance of the X-ray tube. When the oil flow drops below a certain threshold, the system automatically switches to low-dose fluoroscopy and displays the message Low load fluoroscopy flavor …
Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001)…
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Updated Apr 283314 units (816 US, 2498 OUS) units
The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potent…
Hazard. The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the cooling performance of the X-ray tube. When the oil flow drops below a certain threshold, the system automatically switches to low-dose fluoroscopy and displays the message Low load fluoroscopy flavor …
Integris-Allura system; System Code Description (Model Numbers): Integris CV…
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Updated Apr 2825 units (11 US, 14 OUS) units
The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potent…
Hazard. The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the cooling performance of the X-ray tube. When the oil flow drops below a certain threshold, the system automatically switches to low-dose fluoroscopy and displays the message Low load fluoroscopy flavor …
Avanta Multi-Patient Administration Tube Sets (AVA 500 MPAT (Part 2 of 2)) used with the…
Bayer Medical Care
Updated Apr 2411,300 units (1650 US, 9650 OUS) units
Supplier changes resulted in a fit issue with the Contrast Flow Control Valve (CFCV) interface on the Avanta Injector System. Multiple cust…
Hazard. Supplier changes resulted in a fit issue with the Contrast Flow Control Valve (CFCV) interface on the Avanta Injector System. Multiple customer reports indicate that the stopcock cannot be reliably engaged with the CFCV snap interface. In instances where engagement is achieved through applied force, the connection is unstable, and the stopcock may disengage before or during contrast injection, le…
Due to product labeling incorrectly including the symbol indicating non-DEHP (Bis(2-ethylhexyl) phthalate as the product includes 30 to 35%…
Hazard. Due to product labeling incorrectly including the symbol indicating non-DEHP (Bis(2-ethylhexyl) phthalate as the product includes 30 to 35% DEHP.
Affected lots may contain incorrect 0.8-micron filters. Use of a 0.8-micron filter in place of the validated 3-micron filter may lead to re…
Hazard. Affected lots may contain incorrect 0.8-micron filters. Use of a 0.8-micron filter in place of the validated 3-micron filter may lead to reduced flow efficiency, incomplete or slower transfers of ingredients, or system alarms. This issue may lead to clinical effects such as electrolyte imbalance, metabolic instability, delayed recovery, etc.
Description/REF: ACCESS TRAY/ASK-04001-JHH; ACCESS TRAY/ASK-04001-LMDTG; PI CVC KIT: 3…
ARROW INTERNATIONAL
Updated Apr 211,061,069 units
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was foun…
Hazard. Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Description/REF: ARTERIAL LINE KIT: SL 20 GA X 5 IN/ASK-04510-MM6 RA CATH KIT: 20 GA X…
ARROW INTERNATIONAL
Updated Apr 21126,530 units
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was foun…
Hazard. Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was foun…
Hazard. Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Description/REF: EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05502-VM1; EPIDURAL…
ARROW INTERNATIONAL
Updated Apr 211,525,831 units
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was foun…
Hazard. Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was foun…
Hazard. Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Description/REF: PSI KIT: 7 FR X 4IN ANTIMICROBIAL/ASK-09701-UMH; PSI KIT: 8.5 FR X 4 1/8…
ARROW INTERNATIONAL
Updated Apr 21348,684 units
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was foun…
Hazard. Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Description/REF: RA CATH KIT: 20 GA X 1 3/4 IN/TJ-04020-1; RA CATH KIT: 20 GA X 1…
ARROW INTERNATIONAL
Updated Apr 21785,999 units
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was foun…
Hazard. Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was foun…
Hazard. Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Description/REF: RA CATH KIT: 20 GA X 1-1/2IN/NA-04220-1A; RA CATH KIT: 20 GA X…
ARROW INTERNATIONAL
Updated Apr 21310,606 units
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was foun…
Hazard. Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was foun…
Hazard. Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Description/REF: MIDLINE CATHETER KIT: 3 FR X 20 CM/CDC-02031-MK1A; AM/AT PI MIDLINE 1L…
ARROW INTERNATIONAL
Updated Apr 21177,014 units
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was foun…
Hazard. Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Description/REF: RA CATH KIT: 20 GA X 1-3/4IN/AK-04020-SPC; RA CATH KIT: 20 GA X 5…
ARROW INTERNATIONAL
Updated Apr 21491,489 units
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was foun…
Hazard. Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to…
Hazard. Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints.
Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead…
Hazard. Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.
epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material…
Siemens Healthcare Diagnostics
Updated Apr 271725 (38025 US, 33700 OUS) units
Use of the affected product can result in discrepant low pH and measured Total Carbon Dioxide (mTCO2) results and corresponding calculated …
Hazard. Use of the affected product can result in discrepant low pH and measured Total Carbon Dioxide (mTCO2) results and corresponding calculated values in arterial, venous, and capillary patient samples. An erroneously low pH or mTCO2 reading can lead to inappropriate treatment of nonexistent acidosis (respiratory of metabolic) or missed diagnosis of alkalosis (a true high pH: respiratory or metabolic …
Updated Apr 130775 units (25625 US, 5150 OUS) units
Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list …
Hazard. Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26) cartridge lots in the U.S. marketplace may report higher than expected PCO2 and lower than expected pH results due to a manufacturing issue. A falsely high pCO2 together with a falsely low pH makes the blood gas appear as if the patient is in …
Updated Apr 1369650 units (150875 US, 218775… units
Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list …
Hazard. Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26) cartridge lots in the U.S. marketplace may report higher than expected PCO2 and lower than expected pH results due to a manufacturing issue. A falsely high pCO2 together with a falsely low pH makes the blood gas appear as if the patient is in …
ERBEFLO CleverCap CO2: Hybrid CO2 Tubing/Cap Set for Olympus Scopes & CO2 Sources, REF…
Erbe Medical
Updated Mar 31260,962 units
Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may b…
Hazard. Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may be more susceptible to unintended water flow from distal tip under unsupported third-party connector use conditions, which may lead to water aspiration, which may progress to aspiration pneumonia, acute respiratory distress syndrome, or respiratory failure.
Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13;
Gentuity
Updated Mar 23184 units (28 US, 156 OUS) units
The potential for repeated frames during HF-OCT pullback when using the Gentuity HF-OCT Console (software version 21.11 to 23.3.13) with th…
Hazard. The potential for repeated frames during HF-OCT pullback when using the Gentuity HF-OCT Console (software version 21.11 to 23.3.13) with the Vis-Rx and Vis-Rx Prime catheters. This correction is intended to ensure that users are fully informed of how to recognize, avoid, and mitigate this condition to maintain accurate longitudinal (length) measurements during OCT imaging.
Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VALITUDE CRT-P…
Boston Scientific
Updated Mar 19685,776 units units
Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac resynchr…
Hazard. Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps)1 and the advisory population is expanding to include all CRT-P and dual-chamber extended life (DR-EL) devices. Dual chamber modes are specifically indicated for treatment of the following: " Conduction disorders that requi…
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indic…
Hazard. During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
Medline and Centurion medical procedure kits, containing Medline Neuro Sponges (1229 in…
Medline Industries, LP
Updated Mar 19486946 kits units
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indic…
Hazard. During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
Beacon Tip Centimeter Sizing Catheter RPN/GPN NR5.0-35-70-P-10S-0-CSC-20 G31213…
Cook
Updated Apr 24,245 units
Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, …
Hazard. Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may cause life-threatening harm or 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.
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.
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
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.
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.
Spinocan Spinal Needle procedure kits: Material Description (Material Number): Spinocan…
B Braun Medical
Updated May 616,080 units units
These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huon Co, Ltd., has …
Hazard. These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huon Co, Ltd., has issued a voluntary recall due to potential quality issues identified during a recent FDA manufacturing facility inspection.
Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
Fresenius Kabi USA
Updated May 618,444 units
Fresenius Kabi has been made aware via customer complaints that dropping or severe jarring of the Ivenix LVP may cause damage to internal c…
Hazard. Fresenius Kabi has been made aware via customer complaints that dropping or severe jarring of the Ivenix LVP may cause damage to internal components that may not be apparent or readily visible and the devices therefore remained in service. More specifically, drops or jarring on a hard surface can cause the touchscreen input cable to loosen, resulting in unintended touchscreen behavior on the LVP,…
MEDLINE Medical Procedure Kits labeled as CLOVIS HYSTEROSCOPY, CSC-N PELVISCOPY, D AND C…
Medline Industries, LP
Updated May 437324 units units
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues …
Hazard. During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues …
Hazard. During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
MEDLINE Medical Procedure Kits labeled as BASIC GYN, CW LAP GYN, D&C HYSTEROSCOPY, CW LAP…
Medline Industries, LP
Updated May 444656 units units
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues …
Hazard. During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues …
Hazard. During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues …
Hazard. During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before c…
Hazard. Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery.
Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before c…
Hazard. Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery.
Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before c…
Hazard. Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery.
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product …
Hazard. Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
MINOR CATH LAB PACK DYNJ84775A OR VASCULAR ANGIO PACK DYNJ47269D PORT-A-CATH DYNJ63276G
Medline Industries, LP
Updated Apr 2749,654 kits total units
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product …
Hazard. Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product …
Hazard. Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product …
Hazard. Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product …
Hazard. Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product …
Hazard. Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Medline convenience kits: DAVINCI DYNJ905836D DAVINCI-LF DYNJ905293I GENERAL ROBOTICS…
Medline Industries, LP
Updated Apr 2749,654 kits total units
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product …
Hazard. Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product …
Hazard. Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Medline convenience kits: DAVINCI MAIN DYNJ908031D
Medline Industries, LP
Updated Apr 2749,654 kits total units
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product …
Hazard. Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Medline convenience kits: CMH CENTRAL LINE DRESSING CHANGE KIT EBSI1705A CVC/PICC/MIDLINE…
Medline Industries, LP
Updated Apr 2749,654 kits total units
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product …
Hazard. Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product …
Hazard. Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Medline convenience kits: C SECTION CDS985505G C SECTION PACK DYNJ68260D C-SECTION…
Medline Industries, LP
Updated Apr 2749,654 kits total units
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product …
Hazard. Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product …
Hazard. Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product …
Hazard. Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product …
Hazard. Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Medline convenience kits: BIB AV FISTULA PACK DYNJ58304B CARDIAC MINOR SURGICOUNT PACK…
Medline Industries, LP
Updated Apr 2749,654 kits total units
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product …
Hazard. Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Medline convenience kits: ADD-A-CATH ARTERIAL INSERTION ARTNC185 PED SCHOOL AGE PICC DRSG…
Medline Industries, LP
Updated Apr 2749,654 kits total units
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product …
Hazard. Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Medline CCI Nerve Block Tray DYNJRA2742 Medline CPNB DYNJRA2716
Medline Industries, LP
Updated Apr 2749,654 kits total units
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product …
Hazard. Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product …
Hazard. Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product …
Hazard. Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product …
Hazard. Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product …
Hazard. Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL…
Becton Dickinson &
Updated Apr 2713,320 units units
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The…
Hazard. This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.
Intraosseous nerve ablation system instruments may have sterile barrier breach of the outer tray seal, which may introduce a risk of steril…
Hazard. Intraosseous nerve ablation system instruments may have sterile barrier breach of the outer tray seal, which may introduce a risk of sterility breach, and if breached could lead to severe infection.
Description/REF: PI AGBA PICC KIT: 3L 6 FR X 40 CM W/VPS/ASK-44063-NS AGBA PICC/DELTA: 2L…
ARROW INTERNATIONAL
Updated Apr 2137,738 units
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was foun…
Hazard. Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was foun…
Hazard. Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Description/REF: CVC KIT: 16 GA X 8IN/AK-04210, CVC KIT: 1-L 16 GA X 8IN (20…
ARROW INTERNATIONAL
Updated Apr 2135,540 units
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was foun…
Hazard. Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Description/REF: PSI KIT: 7 FR X 4 IN/ASK-09701-UP; PSI KIT: 8.5 FR X 4 1/8 IN (10…
ARROW INTERNATIONAL
Updated Apr 2172,354 units
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was foun…
Hazard. Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Description/REF: BIOPSY SYSTEM COMPREHENSIVE KIT/ASK-09458-AH, ASK-09458-COC…
ARROW INTERNATIONAL
Updated Apr 2114,840 units
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was foun…
Hazard. Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was foun…
Hazard. Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose val…
Hazard. A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend arrows. When the app is running in the background, EGV notifications may queue up and then "replay" sequentially when the user brings the app to the foreground, causing the Glucose Compass to flicker through previous EGVs. In more severe i…
A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose val…
Hazard. A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend arrows. When the app is running in the background, EGV notifications may queue up and then "replay" sequentially when the user brings the app to the foreground, causing the Glucose Compass to flicker through previous EGVs. In more severe i…
A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose val…
Hazard. A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend arrows. When the app is running in the background, EGV notifications may queue up and then "replay" sequentially when the user brings the app to the foreground, causing the Glucose Compass to flicker through previous EGVs. In more severe i…
Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to…
Hazard. Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints.
Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to…
Hazard. Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints.
Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to…
Hazard. Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints.
Cannon II Plus Hemodialysis Catheter, REF: CS-15242-VSP, CS-15282-VSP, CS-15322-VSP…
ARROW INTERNATIONAL
Updated Apr 1034,568 units
16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath i…
Hazard. 16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, tissue injury, vessel wall injury.
16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath i…
Hazard. 16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, tissue injury, vessel wall injury.
16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath i…
Hazard. 16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, tissue injury, vessel wall injury.
Software issue: When programming the SynchroMed Pump with the A810 CP App in Flex Infusion Mode, the infusion steps should automatically be…
Hazard. Software issue: When programming the SynchroMed Pump with the A810 CP App in Flex Infusion Mode, the infusion steps should automatically be arranged in consecutive order, from earliest to latest. However, in rare cases, the steps may be displayed out of order. If this occurs, the programmed Flex Infusion schedule will not be delivered at the intended time, if at all.
BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic use
Becton Dickinson &
Updated Apr 725,760 units units
BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems, where gas generating…
Hazard. BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems, where gas generating sachets may produce carbon dioxide levels below specification.
Embolization coil detachment system devices may experience premature battery drain causing devices to: 1) Not power on; 2) Power on with fa…
Hazard. Embolization coil detachment system devices may experience premature battery drain causing devices to: 1) Not power on; 2) Power on with faint audible and visual indicators; 3) Be unable to detach a coil as intended, which may necessitate medical intervention if the procedure must be completed with an alternative technique.
Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, …
Hazard. Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may cause life-threatening harm or death.
Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list …
Hazard. Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26) cartridge lots in the U.S. marketplace may report higher than expected PCO2 and lower than expected pH results due to a manufacturing issue. A falsely high pCO2 together with a falsely low pH makes the blood gas appear as if the patient is in …
ERBEFLO CleverCap: Hybrid Tubing/Cap Set for Olympus Scopes, 20325-201; ERBEFLO CleverCap…
Erbe Medical
Updated Mar 3123,359 units
Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may b…
Hazard. Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may be more susceptible to unintended water flow from distal tip under unsupported third-party connector use conditions, which may lead to water aspiration, which may progress to aspiration pneumonia, acute respiratory distress syndrome, or respiratory failure.
Brand Name: Disposable Mixing Bowls with Spatula Product Name: Mixing Bowl and Spatula…
Zimmer
Updated Mar 3066960 units
Ten complaints have been received identifying issues at the time of use related to the package seal, including incomplete seals, wrinkles i…
Hazard. Ten complaints have been received identifying issues at the time of use related to the package seal, including incomplete seals, wrinkles in the seals or peeling seals. Compromised sterile barrier may lead to clinically insignificant extension of surgery or infection leading to surgical intervention.
Ophthalmic Tissue Forceps (DEX") are sterile, hand-held ophthalmic surgical instruments designed for grasping, manipulating, compressing, p…
Hazard. Ophthalmic Tissue Forceps (DEX") are sterile, hand-held ophthalmic surgical instruments designed for grasping, manipulating, compressing, pulling, or joining eye and/or surrounding tissues during surgical procedures. These devices fall under the GMDN code 62478 entitled Ophthalmic soft-tissue surgical forceps, probe-like, single use . Double pouched in tyvek pouches, sold in boxes of 5 with an in…
Based on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing rod may, in rare cases, c…
Hazard. Based on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing rod may, in rare cases, come loose from its lock during the mixing process. Notification is to reduce the shelf life from 3 years to 1.5 years (17 months).
Oncology sets/closed system transfer devices with extension sets may leak resulting in therapy delayed if noticed and corrected during setu…
Hazard. Oncology sets/closed system transfer devices with extension sets may leak resulting in therapy delayed if noticed and corrected during setup, but if the leak occurs during therapy this may result in therapy interruption with the potential for the patient to receive less infusion solution than intended. Exposure of hazardous substances to the patient, caregiver, or pharmacy technician is possible.
Brand Name: HiResolution" Bionic Ear System Product Name: M Zn-Air Battery Pak…
Advanced Bionics
Updated Mar 2345173 units
The non-tamperproof battery door supplied with the sound processor fails to conform to IEC 60601-1-11:2015 by not requiring the use of a to…
Hazard. The non-tamperproof battery door supplied with the sound processor fails to conform to IEC 60601-1-11:2015 by not requiring the use of a tool to replace the button/coin cell battery.
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…
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.
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.
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.
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.
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.
Giraffe OmniBed Field Replaceable Unit (FRU), Model Numbers 6600-1056-400 and…
GE Medical Systems
Updated May 1265 units units
GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device. Under certain …
Hazard. GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device. Under certain conditions, for example, impact during transport, one or more of the fasteners that secure the soffit can disengage. If this occurs, a fastener could fall into the patient compartment. In rare circumstances, if multiple fasteners disengage, the canopy soffit c…
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.
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.
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.
Olympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex Bulb. Model…
Olympus of the Americas
Updated May 53,241 units units
Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer…
Hazard. Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.
Olympus Toomey Evacuator 50cc with Adaptor. Model Number: 188A.
Olympus of the Americas
Updated May 51,156 units units
Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer…
Hazard. Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.
Olympus Glass Body for 194 Ellik Evacuator. Model Number: 190A.
Olympus of the Americas
Updated May 53,663 units units
Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer…
Hazard. Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues …
Hazard. During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues …
Hazard. During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues …
Hazard. During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle…
AVID Medical
Updated Apr 305168 kits units
Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of part…
Hazard. Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid path of the Manifolds. Particulate within the fluid path has the potential to be introduced into blood circulation and become lodged within blood vessels.
Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle…
AVID Medical
Updated Apr 305168 kits units
Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of part…
Hazard. Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid path of the Manifolds. Particulate within the fluid path has the potential to be introduced into blood circulation and become lodged within blood vessels.
Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle…
AVID Medical
Updated Apr 305168 kits units
Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of part…
Hazard. Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid path of the Manifolds. Particulate within the fluid path has the potential to be introduced into blood circulation and become lodged within blood vessels.
Philips Azurion systems not configured with an optional auxiliary pan handle. Includes…
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Updated Apr 285,537 units units
Potential safety issue with Philips Azurion systems, where longitudinal and transverse table movements may be impacted due to mechanical we…
Hazard. Potential safety issue with Philips Azurion systems, where longitudinal and transverse table movements may be impacted due to mechanical wear of the Float Tabletop control on the control module.
The recall is being conducted due to corrosion of the internal metallic spring within the sprayer component. This condition is caused by ma…
Hazard. The recall is being conducted due to corrosion of the internal metallic spring within the sprayer component. This condition is caused by material incompatibility between the product solution and the stainless steel spring and may result in visible discoloration and the presence of trace levels of metallic elements (including iron, chromium, and nickel) in the solution during use.
BD¿Spinal Tray with BD¿Quincke Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL…
Becton Dickinson &
Updated Apr 273,130 units units
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The…
Hazard. This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.
BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL…
Becton Dickinson &
Updated Apr 275,940 units units
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The…
Hazard. This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.
BD¿Spinal Tray with BD¿Whitacre Needle 24 G x 3.5 in.; lidocaine HCL (1%), 5 mL…
Becton Dickinson &
Updated Apr 273,550 units units
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The…
Hazard. This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.
Due to unintentionally activated near infrared handheld camera when attempting to turn off illumination during normal clinical workflow tra…
Hazard. Due to unintentionally activated near infrared handheld camera when attempting to turn off illumination during normal clinical workflow transitions, particularly when switching from the handheld camera to the robotic endoscope.
GE HealthCare CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603, Product…
GE Medical Systems Information Technologies
Updated Apr 241249 units units
GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemet…
Hazard. GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).
GE HealthCare ApexPro v6.0 eDelivery Software, REF #5700026, Product Code SUV; used in…
GE Medical Systems Information Technologies
Updated Apr 242187 units units
GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemet…
Hazard. GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).
GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF…
GE Medical Systems Information Technologies
Updated Apr 242366 units units
GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemet…
Hazard. GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).
CASE v7.0 Cardiac Testing System Model no. 3031234-001 Product Code SU3
GE Medical Systems Information Technologies
Updated Apr 241835 units
Electrical sparking may occur at the printer head. If the Electrostatic Discharge (ESD) printer brush becomes dislodged, electrical sparkin…
Hazard. Electrical sparking may occur at the printer head. If the Electrostatic Discharge (ESD) printer brush becomes dislodged, electrical sparking at the printer head can result in charring or discoloration of thermal printer paper. Ignition of the paper could potentially result in serious thermal injury.
OneLIF Interbody Cage (REF/Description): 010-107-1007/Small 7 Degree 10mm X 7mm…
Novapproach Spine
Updated Apr 231259 units
Intervertebral body fusion system straight inserter failed to properly attach to affected cages, which may result in an inability to secure…
Hazard. Intervertebral body fusion system straight inserter failed to properly attach to affected cages, which may result in an inability to securely engage the implant with the inserter, which could lead to procedural delay and/or the need to select an alternative implant.
Description/REF: PI JACC KIT: 2L 5.5 FR X 15 CM CG+/ASK-41552-LTAC; PI JACC KIT: 3L 6 FR…
ARROW INTERNATIONAL
Updated Apr 211,516 units
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was foun…
Hazard. Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was foun…
Hazard. Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Description/REF: HEMODIALYSIS KIT: 2-LUMEN 12 FR X 16 CM/AK-12122-F
ARROW INTERNATIONAL
Updated Apr 211,945 units
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was foun…
Hazard. Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Description/REF: HEMODIALYSIS KIT: 2L 14 FR X 20 CM AGB CDC-25142-X1A
ARROW INTERNATIONAL
Updated Apr 211180 units
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was foun…
Hazard. Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Description/REF: AHDC KIT: 3-L 12 FR X 16 CM/AK-12123-PCDC; AHDC KIT: 3-L 12 FR X 20…
ARROW INTERNATIONAL
Updated Apr 214,270 units
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was foun…
Hazard. Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was foun…
Hazard. Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Digital Angiography System Trinias:UD150G-40 / D150GC-40; Digital Angiography System…
Shimadzu Medical Systems
Updated Apr 203487 units units
Electromagnetic contactors within high voltage generator may weld together, resulting in current being supplied to power supply even if pow…
Hazard. Electromagnetic contactors within high voltage generator may weld together, resulting in current being supplied to power supply even if power is off.
Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071;
Covidien, LP
Updated Apr 152448 units units
The presence of holes in the pouch may compromise the package s ability to maintain the sterile barrier and protect the product from enviro…
Hazard. The presence of holes in the pouch may compromise the package s ability to maintain the sterile barrier and protect the product from environmental exposure.
Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to…
Hazard. Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints.
Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to…
Hazard. Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints.
BD GasPak EZ Campy Pouch System. Catalog Number: 260685. for microbiologic use
Becton Dickinson &
Updated Apr 72,200 units units
BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems, where gas generating…
Hazard. BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems, where gas generating sachets may produce carbon dioxide levels below specification.
Potential for the bolts and plastic parts of the Cable Hose Carriers that hold the cable hose to the monitor ceiling suspension may loosen …
Hazard. Potential for the bolts and plastic parts of the Cable Hose Carriers that hold the cable hose to the monitor ceiling suspension may loosen and/or break over time due to the forces applied when the monitor is moved or rotated.
Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may b…
Hazard. Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may be more susceptible to unintended water flow from distal tip under unsupported third-party connector use conditions, which may lead to water aspiration, which may progress to aspiration pneumonia, acute respiratory distress syndrome, or respiratory failure.
Based on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing rod may, in rare cases, c…
Hazard. Based on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing rod may, in rare cases, come loose from its lock during the mixing process. Notification is to reduce the shelf life from 3 years to 1.5 years (17 months).
Products may report incorrect AST results during quality control. Health consequences may include delayed response or the need to change to…
Hazard. Products may report incorrect AST results during quality control. Health consequences may include delayed response or the need to change to another antifungal agent if laboratory ignores Quality Control test result.
Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco…
Hologic
Updated Mar 231200 units units
It was identified that certain devices were being operated outside the validated and FDA-cleared display configuration due to user modifica…
Hazard. It was identified that certain devices were being operated outside the validated and FDA-cleared display configuration due to user modification of the manufacturer-installed settings. Modifications included disabling Barco Application Appearance Manager (AAM), altering calibration and compliance parameters, and adjusting additional display-related settings. This field correction is being conducte…
Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating…
American Contract Systems
Updated Mar 197,311 kits units
Impacted kits contain syringes recalled by Medline Industries. Syringe rotating adaptor may unwind during use, which may result in a loose …
Hazard. Impacted kits contain syringes recalled by Medline Industries. Syringe rotating adaptor may unwind during use, which may result in a loose connection or full disconnection between the syringe and manifold. Potential risk for biohazard exposure, blood loss, infection, or air embolism.
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1…
Medline Industries, LP
Updated Mar 193290 kits units
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indic…
Hazard. During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1…
Medline Industries, LP
Updated Mar 197004 kits units
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indic…
Hazard. During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
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.
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 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.
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.
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.
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.
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.
Medline Convenience Kits: 1) DYNJ905503F, Model Number: CV ANESTHESIA - ROOM SET UP; 2)…
Medline Industries, LP
Updated May 6227 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.
Neptune Smart Docking Station (120V), Catalog Number 0770-100-000, part of the Neptune…
Stryker
Updated May 61 unit units
It has been identified that the impacted docking station (SN 2521008873) was not product released from manufacturing and may not have compl…
Hazard. It has been identified that the impacted docking station (SN 2521008873) was not product released from manufacturing and may not have completed required testing prior to being shipped to your facility. There is a potential risk of electrical shock due to the device s safety testing being unverifiable.
LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.
Fresenius Kabi USA
Updated May 632 systems units
Potential software anomaly that can cause the pump to report a false battery-health value (typically 69%) and trigger a battery-depletion a…
Hazard. Potential software anomaly that can cause the pump to report a false battery-health value (typically 69%) and trigger a battery-depletion alarm that will shut down the pump unless it is reconnected to AC mains power.
Olympus Toomey Evacuator 30cc with Adaptor. Model Number: 188.
Olympus of the Americas
Updated May 5190 units units
Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer…
Hazard. Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues …
Hazard. During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
MEDLINE Medical Procedure Kits labeled as: PELVIC LAP PACK, Medline Kit Number/ SKU…
Medline Industries, LP
Updated May 420 units units
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues …
Hazard. During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
MEDLINE Medical Procedure Kits labeled as: LAPAROSCOPY COMBINED - NO NDL, Medline Kit…
Medline Industries, LP
Updated May 472 units units
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues …
Hazard. During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues …
Hazard. During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
MEDLINE Medical Procedure Kits labeled as: 1) D AND C PACK, Medline Kit Number/SKU…
Medline Industries, LP
Updated May 4168 units units
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues …
Hazard. During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues …
Hazard. During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues …
Hazard. During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues …
Hazard. During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
MEDLINE Medical Procedure Kits labeled as: ORAL RESTORATION, Medline Kit…
Medline Industries, LP
Updated May 40 units units
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues …
Hazard. During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
Pediatric care bed; Product Designation: KayserBett IDA;
KAYSERBETTEN & KG
Updated May 4372 units units
If the adjustment functions of the hand control, as instructed in the Manual, are not locked with the provided key when the patient (child)…
Hazard. If the adjustment functions of the hand control, as instructed in the Manual, are not locked with the provided key when the patient (child) is unattended, there is an increased risk that the patient (child) or third parties (children) will operate the hand control and trap themselves or others under the bed frame or between the bed frame and the floor. This can lead to serious injuries or even de…
Natus has become aware of two complaints related to the SD LTM 64 PLUS where the EEG traces acquired from two or four different amplifiers …
Hazard. Natus has become aware of two complaints related to the SD LTM 64 PLUS where the EEG traces acquired from two or four different amplifiers used in a multiple amplifier configuration (128 or 256 channels) running firmware version 2022.02 were displayed with a shift of 1 second between the 64channels blocks. In rare circumstances, a fixed 1-second temporal delay may appear between two 64-channel mo…
DigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035.
Philips North America
Updated May 11 unit units
System was delivered without the required Seismic kit for Wall Stand VS2, which is designed to prevent damage and ensure stability of the W…
Hazard. System was delivered without the required Seismic kit for Wall Stand VS2, which is designed to prevent damage and ensure stability of the Wall Stand VS2 during seismic events.
Short Monobloc Stem Broaches, Size/REF: 7/04.01.10.0970, 8/04.01.10.0971…
Medacta Usa
Updated Apr 3050 units
Surgical instruments used during shoulder arthroplasty procedures does not progressively translate to replicate implant geometry, so the re…
Hazard. Surgical instruments used during shoulder arthroplasty procedures does not progressively translate to replicate implant geometry, so the reaming guide and the stem reamer are positioned approximately 0.2 mm per size more laterally than intended, which may increase the risk of fracture in the medial region of the proximal humerus.
Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722003, 722010…
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Updated Apr 30
It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in performance as they age, particularly beyo…
Hazard. It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in performance as they age, particularly beyond six years of service. Issues with an HDD may, depending on the specific system PC in which the affected HDD is installed, result in loss of imaging functionality. Additionally, in Allura systems, this may lead to loss of motorized movement, or loss of data.…
REMISOL Advance with Software Version 2.5 UDI-DI code: 15099590802073 The Normand Info…
Beckman Coulter Biomedical
Updated Apr 2920 systems units
Due to software issues where does not handle combo assay results. The software may replace the final combo test result with one of the sub-…
Hazard. Due to software issues where does not handle combo assay results. The software may replace the final combo test result with one of the sub-results resulting in incorrect reporting of test outcomes.
BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in., BD¿Quincke Needle 22 G x 3.5 in…
Becton Dickinson &
Updated Apr 27290 units units
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The…
Hazard. This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.
BD¿Spinal Tray with BD¿Quincke Needle 26 G x 3.5 in.; lidocaine HCL (1%), 5 mL…
Becton Dickinson &
Updated Apr 27890 units units
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The…
Hazard. This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.
BD¿Spinal Tray with BD¿Whitacre Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL…
Becton Dickinson &
Updated Apr 27330 units units
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The…
Hazard. This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.
BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL…
Becton Dickinson &
Updated Apr 270 units units
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The…
Hazard. This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.
BD¿Spinal Tray with BD¿Quincke Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL…
Becton Dickinson &
Updated Apr 27990 units units
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The…
Hazard. This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.
BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 2 mL…
Becton Dickinson &
Updated Apr 27150 units units
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The…
Hazard. This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.
GE HealthCare CARESCAPE TELEMETRY SERVER V5 ATO MODEL, REF #2063702-101, Product Code…
GE Medical Systems Information Technologies
Updated Apr 24476 units units
GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemet…
Hazard. GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).
GE HealthCare APEXPRO v5.0 - ARK2250 - Software Disaster Recovery USB Kit - Orderable by…
GE Medical Systems Information Technologies
Updated Apr 2414 units units
GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemet…
Hazard. GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).
GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemet…
Hazard. GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).
Operative components of surgical systems potentially distributed with E-brake retainer pin, so in event of a structural column failure, the…
Hazard. Operative components of surgical systems potentially distributed with E-brake retainer pin, so in event of a structural column failure, the E-brake pin would prevent E-brake engagement and may result in uncontrolled motion. In addition, if it moves/backs out it may cause restricted column range of motion and/or uncontrolled motion, which may cause patient tissue injury/crushing injury/bleeding.
RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers: 28-N4-32-104-32U…
Bolton Medical
Updated Apr 22
Labeling update concerning proximal clasp disconnection from the outer control tube which may prevent stent graft from being released from …
Hazard. Labeling update concerning proximal clasp disconnection from the outer control tube which may prevent stent graft from being released from the delivery system.
Adapter for Head Positioning, Model/Catalog Number: 1739994, when used in conjunction…
Baxter Healthcare
Updated Apr 2113 units units
The Adapter for Head Positioning accessory may become loose during patient positioning and unintentionally move when used in conjunction wi…
Hazard. The Adapter for Head Positioning accessory may become loose during patient positioning and unintentionally move when used in conjunction with the side rails of the Upper Back Section H V U component on Baxter operating tables.
Description/REF: PI MIDLINE 2L: 5FR X 20CM/CDC-32052-MPKC
ARROW INTERNATIONAL
Updated Apr 2190 units
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was foun…
Hazard. Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was foun…
Hazard. Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Multi-Snare Set: 5 mm x 125 cm, REF: 147305; 10 mm x 125 cm, REF: 147310
PFM MEDICAL
Updated Apr 2132 units
A snare catheter including luer lock, indicated for removal or manipulation of a foreign body in the vascular system, failed to meet the bi…
Hazard. A snare catheter including luer lock, indicated for removal or manipulation of a foreign body in the vascular system, failed to meet the biocompatibility requirements for in-vitro-cytotoxicity, which if in contact with a patient's vasculature could result in localized inflammation and tissue irritation.
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was foun…
Hazard. Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Description/REF: SAC KIT: 18 GA X 12CM W BIO/SAC-01218-B; SAC KIT: 18 GA X 12CM W…
ARROW INTERNATIONAL
Updated Apr 21
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was foun…
Hazard. Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was foun…
Hazard. Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis System…
GE Medical Systems China
Updated Apr 2116 units
Software in development inadvertently made available for customer use. Use of this software version can result in clinical information bein…
Hazard. Software in development inadvertently made available for customer use. Use of this software version can result in clinical information being associated with the incorrect patient. This could impact clinical decision-making.
Due to a software coding issues for calculating the implant orientation diagram printout for the implantation for toric implantable collame…
Hazard. Due to a software coding issues for calculating the implant orientation diagram printout for the implantation for toric implantable collamer lenses.
GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. Thi…
Hazard. GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON.
GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. Thi…
Hazard. GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON.
GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. Thi…
Hazard. GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON.
GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. Thi…
Hazard. GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON.
GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. Thi…
Hazard. GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON.
A retrospective review identified that there are AIC units requiring specific hardware updates to address potential safety concerns. These …
Hazard. A retrospective review identified that there are AIC units requiring specific hardware updates to address potential safety concerns. These hardware updates have been implemented through Abiomed s servicing process; therefore, AICs that have not received service are pending these updates. Issue 1: The proximity of the internal Video Graphics Array cable to the Digital Signal Processor chipset on t…
It was reported that plates 2 and 3 were marked as passed , although it appeared that QC had not been performed on these plates, despite sa…
Hazard. It was reported that plates 2 and 3 were marked as passed , although it appeared that QC had not been performed on these plates, despite samples being measured. The potential clinical hazards include false or missed detection of M-protein (false positive); and falsely elevated or decreased M-protein concentration.
Fresh Roast Systems ColorTrack. Model Name: ColorTrack. Model Number: BENCH R-100
Fresh Roast Systems
Updated Apr 1538 units
A defect has been identified in the manufacture of the Fresh Roast Systems ColorTrack instrument model number BENCH R-100 which could under…
Hazard. A defect has been identified in the manufacture of the Fresh Roast Systems ColorTrack instrument model number BENCH R-100 which could under very rare specific misuse circumstances potentially allow human access to infrared laser light levels in excess of the safety Classification of the product.
Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (REF)…
Philips North America
Updated Apr 141 unit units
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's …
Hazard. The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Philips SmartPath to dStream for 1.5T with MR Elastography (MRE). 1. Model Number (REF)…
Philips North America
Updated Apr 146 units units
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's …
Hazard. The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Philips SmartPath to dStream for XR and 3.0T with MR Elastography (MRE). 1. Model Number…
Philips North America
Updated Apr 1414 units units
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's …
Hazard. The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Philips Ingenia Ambition X with MR Elastography (MRE). 1. Model Number (REF): 781356. 2…
Philips North America
Updated Apr 1486 units units
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's …
Hazard. The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Philips Upgrade to MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782130.
Philips North America
Updated Apr 1415 units units
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's …
Hazard. The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Philips Ingenia Elition S with MR Elastography (MRE). 1. Model Number (REF): 781357. 2…
Philips North America
Updated Apr 146 units units
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's …
Hazard. The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Philips Evolution Upgrade 1.5T with MR Elastography (MRE). 1. Model Number (REF): 782116…
Philips North America
Updated Apr 148 units units
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's …
Hazard. The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Philips Achieva 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781278.
Philips North America
Updated Apr 141 unit units
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's …
Hazard. The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Philips MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782120. 2. Model…
Philips North America
Updated Apr 1425 untis units
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's …
Hazard. The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model…
Philips North America
Updated Apr 1454 units units
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's …
Hazard. The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Philips Achieva 1.5T Initial system with MR Elastography (MRE). 1. Model Number (REF)…
Philips North America
Updated Apr 141 unit units
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's …
Hazard. The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2…
Philips North America
Updated Apr 1422 units units
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's …
Hazard. The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2…
Philips North America
Updated Apr 14103 units units
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's …
Hazard. The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Philips Ingenia 1.5T CX with MR Elastography (MRE). 1. Model Number (REF): 781262.
Philips North America
Updated Apr 141 unit units
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's …
Hazard. The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Philips Achieva 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781196. 2. Model…
Philips North America
Updated Apr 143 units units
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's …
Hazard. The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Philips Ingenia Ambition S with MR Elastography (MRE). 1. Model Number (REF): 781359. 2…
Philips North America
Updated Apr 147 units units
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's …
Hazard. The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Philips Evolution upgrade 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782143…
Philips North America
Updated Apr 143 units units
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's …
Hazard. The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model…
Philips North America
Updated Apr 1464 units units
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's …
Hazard. The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Philips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF)…
Philips North America
Updated Apr 143 units units
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's …
Hazard. The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
LUCAS 2 Model Number: 99576 Catalog Numbers: 99576-000024 and 99576-000011 UDI-DI code…
Jolife AB
Updated Apr 13153 systems units
Due to a subset of chest compression systems/devices where the service performed on the systems were not appropriately documented (The docu…
Hazard. Due to a subset of chest compression systems/devices where the service performed on the systems were not appropriately documented (The documents for the service performed to justify the passing results were not include in the service records).
Some defibrillators serviced between July 2023 through November 2025 were serviced without objective evidence that a Performance Inspection…
Hazard. Some defibrillators serviced between July 2023 through November 2025 were serviced without objective evidence that a Performance Inspection Procedure (PIP) was conducted, and the inability to perform the device's intended use may result in potential harms such as delays or inability to provide therapy.
Medline medical convenience kit labeled as EYE TRAY-LF, Medline Kit SKU DYNJ21627P
Medline Industries, LP
Updated Apr 108 kits units
Specific Medline Kits contain Cardinal Health Monoject 1mL Luer Lock Syringes, Tuberculin Print, Sterile. Cardinal Health has recalled thes…
Hazard. Specific Medline Kits contain Cardinal Health Monoject 1mL Luer Lock Syringes, Tuberculin Print, Sterile. Cardinal Health has recalled these syringes because the outer carton and blister pack are labeled as a 1 mL Luer Lock Tuberculin Syringe (Product Code 1180100777), but the syringes inside are U-100 insulin syringes.
Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to…
Hazard. Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints.
16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath i…
Hazard. 16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, tissue injury, vessel wall injury.
Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead…
Hazard. Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.
Swan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755P
Becton, Dickinson and
Updated Apr 8183 units
Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead…
Hazard. Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.
The intended use is to be paired with a weapon for aiming purposes.
Wilcox Industries
Updated Apr 6N/A units
Wilcox is notifying all customers who have purchased a product from the BOSS Xe family that a software enhancement to increase safety has b…
Hazard. Wilcox is notifying all customers who have purchased a product from the BOSS Xe family that a software enhancement to increase safety has been released and all units should be returned to implement this change.
LVIS Intraluminal Support Device, REF/Outside Diameter(OD)xTotal Length(TL)xWorking…
MICROVENTION
Updated Apr 638 units
Stent-assisted coiling device may due to commingling during manufacturing have dimensional nonconformance and/or incorrect device configura…
Hazard. Stent-assisted coiling device may due to commingling during manufacturing have dimensional nonconformance and/or incorrect device configuration. If device is oversized may lead to increased vessel wall stress, neointimal hyperplasia, vessel injury/rupture; if undersized may lead to incomplete expansion/malposition, acute stent thrombosis, distal embolization, ischemic neurological events
Custom Convenience Kit containing recalled Medline Namic Angiographic Control Syringes…
Windstone Medical Packaging
Updated Apr 2150 kits (US only) units
Affected kits contain Medline Namic RA Syringes, which are recalled by their manufacturer due to risk of syringe rotating adapter unwinding…
Hazard. Affected kits contain Medline Namic RA Syringes, which are recalled by their manufacturer due to risk of syringe rotating adapter unwinding during use, which may result in a loose connection or full disconnection between syringe and manifold. If unwinding occurs, there is a potential for biohazard exposure, blood loss, infection. or air embolism.
ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A
Aniara Diagnostica
Updated Apr 1359 units units
Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorre…
Hazard. Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.
LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATITUDE DRAGON…
Boston Scientific
Updated Mar 30148 units units
For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (bot…
Hazard. For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or monitoring for Bradyarrhythmia and Pause (M312 only). In addition, for these devices that are not being monitored, the LATITUDE Clarity programming screens have discrepant information, indicating that the monitoring is enabled for these feature…
LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US…
Boston Scientific
Updated Mar 302 units units
For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (bot…
Hazard. For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or monitoring for Bradyarrhythmia and Pause (M312 only). In addition, for these devices that are not being monitored, the LATITUDE Clarity programming screens have discrepant information, indicating that the monitoring is enabled for these feature…
AIDBAGs are first aid kits of convenience composed of individually labeled devices…
North American Rescue
Updated Mar 2721 units
Kits contain the McKesson TRUE Metrix PRO Professional Monitoring Blood Glucose System that has been recalled for an issue with the softwar…
Hazard. Kits contain the McKesson TRUE Metrix PRO Professional Monitoring Blood Glucose System that has been recalled for an issue with the software design of the E-5 Error Code where the meter displays an E-5 error code for a very high blood glucose event (> 600 mg/dL) or when there is a test strip error, which can lead to operator confusion when evaluating patients and a delay in appropriate treatment.…
Revolution Apex Plus, X-ray Computed Tomography, Model Number 5590000-25
GE Medical Systems
Updated Mar 2611 units units
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Sma…
Hazard. GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.
Revolution Apex, X-ray Computed Tomography, Model Number 5590000-20
GE Medical Systems
Updated Mar 2624 units units
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Sma…
Hazard. GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.
Revolution Apex Elite, X-ray Computed Tomography, Model Number 5590000-23
GE Medical Systems
Updated Mar 2633 units units
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Sma…
Hazard. GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.
Revolution Apex Select, X-ray Computed Tomography, Model Number 5590000-27
GE Medical Systems
Updated Mar 265 units units
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Sma…
Hazard. GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.
Revolution Ascend, computed tomography, Model Numbers 6969000-100 and 6969000-300
GE Medical Systems
Updated Mar 2625 units units
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Sma…
Hazard. GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.
Revolution CT ES, X-ray Computed Tomography, Model Number 5590000-15
GE Medical Systems
Updated Mar 2610 units units
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Sma…
Hazard. GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.
Revolution CT, x-ray computed tomography, Model Numbers 5590000 and 5590000-6
GE Medical Systems
Updated Mar 2638 units units
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Sma…
Hazard. GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.
VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000
Ventec Life Systems
Updated Mar 2542 units
Respiratory system intended to provide continuous/intermittent ventilator support, may not have been evaluated under all intended high-pres…
Hazard. Respiratory system intended to provide continuous/intermittent ventilator support, may not have been evaluated under all intended high-pressure conditions during production testing, so an oxygen leak condition could occur that may lead to reduced below intended levels of fraction of inspired oxygen delivery prior to and during ventilation and this oxygen-enriched environment may increase fire risk
Hintermann Series Talar Implant, Left, Size 2 REF 302112
DT MedTech
Updated Mar 2467 units units
Through customer complaints, the ankle replacement system was found to contain incorrect devices: Left implant packaging and labeling bears…
Hazard. Through customer complaints, the ankle replacement system was found to contain incorrect devices: Left implant packaging and labeling bears a right implant device.
Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within…
Foundation Medicine
Updated Mar 2410 units units
Potential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys protocols after deployment of the PCT soft…
Hazard. Potential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys protocols after deployment of the PCT software for AutoLys Hamilton STAR.
Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement.
Centinel Spine
Updated Mar 2030 units units
Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and prodisc C SK U.S. Implant Extra Lar…
Hazard. Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and prodisc C SK U.S. Implant Extra Large 5mm product was labeled as a 6mm.
Prodisc C SK U.S. IMPLANT EXTRA LARGE 6MM. Model Number: PDSXL6. Total cervical disc…
Centinel Spine
Updated Mar 2030 units units
Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and prodisc C SK U.S. Implant Extra Lar…
Hazard. Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and prodisc C SK U.S. Implant Extra Large 5mm product was labeled as a 6mm.