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.
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.
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…
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.
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.
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.
Medline medical procedure kits, containing Medline Neuro Sponges (961 in total), NEURO,
Medline Industries, LP
Updated Mar 19538201 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 (4077 in total)…
Medline Industries, LP
Updated Mar 191552486 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 (1050 in total)…
Medline Industries, LP
Updated Mar 19263739 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.
Boston Scientific Pacemaker, Implantable Pulse Generator, Pacemaker (non- Cardiac…
Boston Scientific
Updated Mar 19718,456 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…
B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG. Model Number…
B Braun Medical
Updated Mar 192,653,711 units units
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative press…
Hazard. Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
B. Braun Hemodialysis Bloodlines, STREAMLINE FRESENIUS FOR DAVITA. Model Number…
B Braun Medical
Updated Mar 191,174,271 units units
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative press…
Hazard. Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG DR. Model Number…
B Braun Medical
Updated Mar 193,158,104 units units
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative press…
Hazard. Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
B. Barun Hemodialysis Bloodlines, StreamLine Bloodline Long Version, FMC. Model Number…
B Braun Medical
Updated Mar 19328,640 units units
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative press…
Hazard. Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
Beckman Coulter has identified that Access Total T4 Calibrator lots (PN 33805) exhibit a negative bias on DxI 600/800 instruments, with slo…
Hazard. Beckman Coulter has identified that Access Total T4 Calibrator lots (PN 33805) exhibit a negative bias on DxI 600/800 instruments, with slopes outside product specifications. A false low patient result could cause a patient to undergo unnecessary additional diagnostic testing. A patient may be treated for a disorder not present or receive delayed treatment for hyperthyroidism. For a pregnant pati…
(1)(2) LeadCare¿ II Blood Lead Test Kit, (3)LeadCare¿ II 5X Blood Lead Test Kit…
Magellan Diagnostics
Updated Mar 13197893 units
Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary sam…
Hazard. Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test Systems. False positive lead results may cause delayed results and additional unnecessary testing.
Due to a manufacturing defect, certain Omnipod 5 Pods from 49 lots have an internal soft cannula tear that results in insulin leaking into …
Hazard. Due to a manufacturing defect, certain Omnipod 5 Pods from 49 lots have an internal soft cannula tear that results in insulin leaking into the Pod instead of being delivered to the user regardless of basal or bolus delivery. This defect results from damage to the unexposed portion of the soft cannula during manufacturing, which would result in a compromised fluid path. The primary failure mode is…
ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600…
Siemens Medical Solutions USA
Updated Mar 10U.S. 758, OUS 2077 units
During patient examinations, the system may sporadically display a major increase of the x-ray dose applied to the patient. Despite the rep…
Hazard. During patient examinations, the system may sporadically display a major increase of the x-ray dose applied to the patient. Despite the reported dose showing significantly higher, the actual applied x-ray dose levels are in accordance with the system settings and imaging conditions, as well as the applicable regulatory requirements.
The product is a handheld ultraviolet-C germicidal wand and contains two low-pressure…
Uvlizer c/o RAIS INTERNATIONAL
Updated Mar 6480,000 units
In some foreseeable use conditions, the Products can expose nearby persons to UVC radiation at levels significantly above limits recommende…
Hazard. In some foreseeable use conditions, the Products can expose nearby persons to UVC radiation at levels significantly above limits recommended by international safety guidelines for skin and eye exposure.
Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 65CM 038 NB 0SH…
Angiodynamics
Updated Mar 34925 units (985 boxes) units
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diam…
Hazard. The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 21 R/O Markers; ACCU-VU OF 4F…
Angiodynamics
Updated Mar 3500 units (100 boxes) units
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diam…
Hazard. The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided; SOFT-VU OF 4F X 65CM 035 NB 6SH…
Angiodynamics
Updated Mar 34840 units (484 boxes) units
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diam…
Hazard. The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 65CM 038 NB 0SH…
Angiodynamics
Updated Mar 31520 units (304 boxes) units
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diam…
Hazard. The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided; SOFT-VU OF 4F X 65CM 038 NB 6SH…
Angiodynamics
Updated Mar 31550 units (155 boxes) units
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diam…
Hazard. The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 035 NB 0SH…
Angiodynamics
Updated Mar 35155 units (1031 boxes) units
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diam…
Hazard. The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 2 R/O Markers; ACCU-VU OF 4F…
Angiodynamics
Updated Mar 3515 units (103 boxes) units
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diam…
Hazard. The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 100CM 038 NB 0SH…
Angiodynamics
Updated Mar 3615 units (123 boxes) units
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diam…
Hazard. The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 100CM 038 NB…
Angiodynamics
Updated Mar 31030 units (206 boxes) units
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diam…
Hazard. The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES …
Hazard. Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES …
Hazard. Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES …
Hazard. Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes…
Medline Industries, LP
Updated Feb 27113,843 kits units
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES …
Hazard. Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES …
Hazard. Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. DR G'S…
Medline Industries, LP
Updated Feb 27113,843 kits units
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES …
Hazard. Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES …
Hazard. Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES …
Hazard. Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES …
Hazard. Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES …
Hazard. Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES …
Hazard. Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES …
Hazard. Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES …
Hazard. Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes…
Medline Industries, LP
Updated Feb 27113,843 kits units
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES …
Hazard. Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES …
Hazard. Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES …
Hazard. Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline…
Medline Industries, LP
Updated Feb 27149439 kits units
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during us…
Hazard. Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline…
Medline Industries, LP
Updated Feb 271752096 kits units
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during us…
Hazard. Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline…
Medline Industries, LP
Updated Feb 272630369 units units
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during us…
Hazard. Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
NAMIC Angiographic Control Syringe, labeled as follows: 1. SYRINGE,7ML,TR/FR,RA,W/RES,-,P/…
Medline Industries, LP
Updated Feb 27192690 units units
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during us…
Hazard. Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
See RES for complete list. Medline Convenience Kits: 1) MAJOR LAPAROTOMY CDS, Model…
Medline Industries, LP
Updated Jan 7114778 units units
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed …
Hazard. Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
See RES for complete list. Medline Convenience Kits: 1) SPINAL CDS, Model Number…
Medline Industries, LP
Updated Jan 7160980 units units
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed …
Hazard. Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
See complete list in RES, exceeds character limit. Medline Surgical Gowns
Medline Industries, LP
Updated Jan 770376042 units units
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed …
Hazard. Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline Surgical Packs: 1) PACK,UNIVERSAL,ULTRAGARD,5/CS, Model Number: DYNJP1050UG; 2)…
Medline Industries, LP
Updated Jan 7193157 units units
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed …
Hazard. Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
See RES for complete list. Medline Convenience Kits: 1) DRAWER 6-IV FLUIDS GLOVES, Model…
Medline Industries, LP
Updated Jan 7207196 units units
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed …
Hazard. Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline Surgical Drapes: 1) SHEET,DRAPE,40X58,STERILE, Model Number: DYNJP2410; 2)…
Medline Industries, LP
Updated Jan 714927765 units units
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed …
Hazard. Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
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.
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.
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.
Medline medical procedure kits, containing Medline Neuro Sponges (102 in total)
Medline Industries, LP
Updated Mar 1922116 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…
Medline Industries, LP
Updated Mar 1910400 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 1921288 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.
Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.
Siemens Healthcare Diagnostics
Updated Mar 1818,080 units units
Siemens Healthcare Diagnostics is recalling certain lots of Dimension Creatinine Flex reagent cartridge (Dimension CRE2) because a potentia…
Hazard. Siemens Healthcare Diagnostics is recalling certain lots of Dimension Creatinine Flex reagent cartridge (Dimension CRE2) because a potential imprecision in the Dimension CRE2 quality control (QC) and patient sample results using lot numbers GA6307 and BA7005 on the Dimension System. This imprecision may lead to erroneously decreased or increased creatinine patient results
Medline or Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads…
Medline Industries, LP
Updated Mar 1628550 kits units
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol …
Hazard. Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Webcol Large Alcohol Prep Pads to be non-sterile following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
Medline and Centurion medical convenience kits, containing Webcol Large Alcohol Prep…
Medline Industries, LP
Updated Mar 1640845 kits units
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol …
Hazard. Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Webcol Large Alcohol Prep Pads to be non-sterile following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
Medline and Centurion medical convenience kits, containing Webcol Large Alcohol Prep…
Medline Industries, LP
Updated Mar 1617550 kits units
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol …
Hazard. Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Webcol Large Alcohol Prep Pads to be non-sterile following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
Stryker Sustainability Solution Color Cuff 24" (Yellow) Quick Connect Dual Port Single…
Stryker Sustainability Solutions
Updated Mar 1256,740 cuffs units
Due to potential for tourniquet cuffs to detach from the bladder at the welding connection and result in the cuff not being able to maintai…
Hazard. Due to potential for tourniquet cuffs to detach from the bladder at the welding connection and result in the cuff not being able to maintain pressure.
Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac…
Medtronic
Updated Mar 1177510 units units
ventricular fibrillation (VF) during radiofrequency (RF) therapy with the Medtronic Sphere-9 catheter in patients who have a Biotronik Impl…
Hazard. ventricular fibrillation (VF) during radiofrequency (RF) therapy with the Medtronic Sphere-9 catheter in patients who have a Biotronik Implantable Cardioverter Defibrillator (ICD) or Biotronik Cardiac Resynchronization Therapy-Defibrillator (CRT-D) implanted. The observation is caused by an interaction between the Sphere-9 catheter current flow and a safety feature built into Biotronik ICDs and C…
Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 100CM 038 NB 0SH…
Angiodynamics
Updated Mar 3210 units (42 boxes) units
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diam…
Hazard. The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Soft-Vu Angiographic Catheter, Sos Omni Selective (1), Non-Braided; SOFT-VU SO1 4F X 80CM…
Angiodynamics
Updated Mar 3320 units (64 boxes) units
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diam…
Hazard. The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Soft-Vu Angiographic Catheter, Straight Art, Non-Braided; SOFT-VU STR ART 4F X 65CM 035…
Angiodynamics
Updated Mar 3220 units (44 boxes) units
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diam…
Hazard. The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 100CM 035 NB 10SH…
Angiodynamics
Updated Mar 3450 units (45 boxes) units
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diam…
Hazard. The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diam…
Hazard. The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 65CM 038 NB 10SH…
Angiodynamics
Updated Mar 3950 units (95 boxes) units
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diam…
Hazard. The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Oxoid Ltd., part of Thermo Fisher Scientific, confirmed that Microbact 12L Kit 20 Tests MB1128A lot 4494873 may identify incorrect organism…
Hazard. Oxoid Ltd., part of Thermo Fisher Scientific, confirmed that Microbact 12L Kit 20 Tests MB1128A lot 4494873 may identify incorrect organism due to inconclusive result from ambiguous color reactions in wells.
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA)…
Medline Industries, LP
Updated Feb 2779843 units units
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during us…
Hazard. Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA)…
Medline Industries, LP
Updated Feb 2717902 kits units
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during us…
Hazard. Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
See Luer Cap Set, MPC-130, set, administration, intravascular
Molded Products
Updated Feb 1726900 units units
Molded Products, Inc. is voluntarily conducting a medical device recall of the MPC-130 See Luer Cap Set based on a confirmed complaint of t…
Hazard. Molded Products, Inc. is voluntarily conducting a medical device recall of the MPC-130 See Luer Cap Set based on a confirmed complaint of the threaded sleeve not being engaged and becoming un-attached.
Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment …
Hazard. Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential consequences associated with detachment of fragments from valve include foreign body in patient's tracheobronchial tree, which may require intervention for removal. Other potential consequences include inflamm…
Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment …
Hazard. Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential consequences associated with detachment of fragments from valve include foreign body in patient's tracheobronchial tree, which may require intervention for removal. Other potential consequences include inflamm…
All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and un…
Hazard. All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevat…
All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and un…
Hazard. All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevat…
All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and un…
Hazard. All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevat…
All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and un…
Hazard. All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevat…
In certain situations, following a system reboot, one or more modules may have become unreachable via the remote connectivity interface. Wh…
Hazard. In certain situations, following a system reboot, one or more modules may have become unreachable via the remote connectivity interface. When this occurred, there was potential for delays in plate retrieval from the incubator while connectivity was restored. This issue was intermittent and did not affect test results, performance of the assay, or sample integrity.
See RES for complete list. Medline Convenience Kits: 1) OPEN HEART CDS, Model…
Medline Industries, LP
Updated Jan 751061 units units
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed …
Hazard. Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline Convenience Kits: 1) PPE KIT, Model Number: DYK1011945P
Medline Industries, LP
Updated Jan 713025 units units
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed …
Hazard. Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline Convenience Kits: 1) BAPTIST FLOYD ENDO GI KIT, Model Number: DYKE1455B; 2) GI…
Medline Industries, LP
Updated Jan 723238 units units
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed …
Hazard. Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
See full list in RES, exceeds character limit 1) GYN LAPAROSCOPY CDS, Model Number…
Medline Industries, LP
Updated Jan 715806 units units
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed …
Hazard. Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed …
Hazard. Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
See RES for full list. Medline Convenience Kits: 1) CHP COCHLEAR SUPPLEMENT CDS, Model…
Medline Industries, LP
Updated Jan 711575 units units
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed …
Hazard. Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline Convenience Kits: 1) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407N; 2)…
Medline Industries, LP
Updated Jan 713376 units units
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed …
Hazard. Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline Convenience Kits: 1) OB KIT, Model Number: DYKM2326; 2) KIT LABOR DELIVERY TUBAL…
Medline Industries, LP
Updated Jan 729192 units
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed …
Hazard. Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed …
Hazard. Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed …
Hazard. Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
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…
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.
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.
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 has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed …
Hazard. Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
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.
Centurion medical procedure kits, containing Medline Neuro Sponges, labeled as follows…
Medline Industries, LP
Updated Mar 193000 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 192228 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 193170 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 192153 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 193588 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 191294 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 199805 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 194016 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 194324 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 191824 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.
B. Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 2.6MM PUMP SEGMENT. Model Number…
B Braun Medical
Updated Mar 194,848 units units
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative press…
Hazard. Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
B Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 4.8MM PUMP SEGMENT. Model Number…
B Braun Medical
Updated Mar 194,884 units units
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative press…
Hazard. Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device…
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Updated Mar 191,033 units units
Potential safety issue involving the Mean Aneurysm Flow Amplitude (MAFA) ratio of AneurysmFlow (Interventional Tool). Philips has determine…
Hazard. Potential safety issue involving the Mean Aneurysm Flow Amplitude (MAFA) ratio of AneurysmFlow (Interventional Tool). Philips has determined that the MAFA ratio does not provide reliable prognostic information regarding aneurysm occlusion following Flow Diverter Stent treatment, however despite being stated in the IUF, it is being relied on for making clinical decisions.
The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation …
Hazard. The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.
Medical Action Industries Inc. Pack Cath BHH, REF: BHCA49K, Sterile EO, Rx Only, QTY…
Medical Action Industries 306
Updated Mar 172030 kits units
Convenience kit contains a syringe in which the rotating adapter may unwind during use, resulting in a loose connection and/or full disconn…
Hazard. Convenience kit contains a syringe in which the rotating adapter may unwind during use, resulting in a loose connection and/or full disconnection between the syringe and manifold"
Medline medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as…
Medline Industries, LP
Updated Mar 164050 kits units
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol …
Hazard. Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Webcol Large Alcohol Prep Pads to be non-sterile following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled…
Medline Industries, LP
Updated Mar 161590 kits units
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol …
Hazard. Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Webcol Large Alcohol Prep Pads to be non-sterile following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection …
Hazard. Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Halyard PERC TRAY kit. Model Numbers: SLPC34-01, SLPC34-02.
AVID Medical
Updated Mar 136,052 kits units
Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection …
Hazard. Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Halyard SAMMC ANGIOGRAPHY kit. Model Numbers: SAMM066-15.
AVID Medical
Updated Mar 132,392 kits units
Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection …
Hazard. Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Halyard HEART CATH, SELF REGIONAL kit. Model Number: SELF131-05.
AVID Medical
Updated Mar 132,932 kits units
Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection …
Hazard. Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
insulin pump software versions 1.4.2, and 1.4.3 issue with Dexcom Continuous Glucose Monitoring (CGM) G7 sensor may result in delayed CGM r…
Hazard. insulin pump software versions 1.4.2, and 1.4.3 issue with Dexcom Continuous Glucose Monitoring (CGM) G7 sensor may result in delayed CGM reading then switch to non-CGM dosing, leading to only basal/requested meal doses provided, no correction doses/insulin reductions/suspensions for high/low glucose unless blood glucose entered for sensor life or replacement. Potential health risks to users incl…
B.R.A.H.M.S PlGF Plus KRYPTOR, Catalog Number: 859075N. in vitro diagnostic test for…
Brahms
Updated Mar 125,254 units
Customers have observed quality control values out of range at the lowest quality control level (QC Level 1) for the PIGF assay which requi…
Hazard. Customers have observed quality control values out of range at the lowest quality control level (QC Level 1) for the PIGF assay which require troubleshooting steps to resolve. If Quality Controls are not performed according to the Instructions for Use, the underestimation of QC1 may go undetected and could contribute to falsely elevated sFlt-1/PlGF ratio results. A falsely elevated sFlt-1/PlGF ra…
Soft-Vu Angiographic Catheter, Cobra (1), Non-Braided; SOFT-VU CB1 4F X 100CM 038 NB 0SH…
Angiodynamics
Updated Mar 380 units (16 boxes) units
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diam…
Hazard. The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diam…
Hazard. The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor
Spacelabs Healthcare
Updated Feb 271790 units
Multi-parameter command module has a circuit board issue and when in Auto mode, Cardiac Output (CO) measurement may activate early, resulti…
Hazard. Multi-parameter command module has a circuit board issue and when in Auto mode, Cardiac Output (CO) measurement may activate early, resulting in Bad Curve error with no CO measurement or Irregular Curve error with CO measurement not automatically excluded, which may result in inaccurate readings, or the need of additional readings, which may lead to delayed care and/or fluid overload.
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA)…
Medline Industries, LP
Updated Feb 272154 units units
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during us…
Hazard. Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA)…
Medline Industries, LP
Updated Feb 271698 kits units
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during us…
Hazard. Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA)…
Medline Industries, LP
Updated Feb 273120 kits units
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during us…
Hazard. Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA)…
Medline Industries, LP
Updated Feb 272980 kits units
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during us…
Hazard. Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Brand Name: B. BRAUN MEDICAL INC. Product Name: NES1725KFXL SPINAL EPID CLOSED TIP CATH…
B Braun Medical
Updated Jan 291730 units
B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL¿ Liquid Adhesive, that they have issued a …
Hazard. B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL¿ Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable.
See RES for complete list. Medline Convenience Kits: 1) PLASTIC BIN W/MISC KITS, Model…
Medline Industries, LP
Updated Jan 75497 units units
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed …
Hazard. Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline Convenience Kits: 1) PICC LINE TRAY, Model Number:00-401993O; 2) CODE CART ADULT…
Medline Industries, LP
Updated Jan 75562 units units
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed …
Hazard. Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed …
Hazard. Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed …
Hazard. Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed …
Hazard. Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed …
Hazard. Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed …
Hazard. Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline Convenience Kits: 1) CVC PACK, Model Number: CVI4500A; 2) TOTE KAMAL OSC HAND…
Medline Industries, LP
Updated Jan 71516 units units
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed …
Hazard. Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline Convenience Kits: 1) CENTRAL LINE UNIVERSAL INSERTI, Model Number: CVI3780; 2)…
Medline Industries, LP
Updated Jan 71056 units units
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed …
Hazard. Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline Convenience Kits: 1) ADMIT KIT, Model Number: DYKA1343A
Medline Industries, LP
Updated Jan 71090 units units
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed …
Hazard. Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed …
Hazard. Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed …
Hazard. Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Brand Name: Cellex Photopheresis System Product Name: CELLEX Photopheresis Kit…
THERAKOS DEVELOPMENT
Updated May 165826 units
Increased difficulty in installing the centrifuge bowl onto the centrifuge bowl holder. Improper installation may cause the centrifuge bowl…
Hazard. Increased difficulty in installing the centrifuge bowl onto the centrifuge bowl holder. Improper installation may cause the centrifuge bowl to dislodge, resulting in a broken bowl during the prime cycle or treatment phase, leading to a delay in patient treatment and blood loss.
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.
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, 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.
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.
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.
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.
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.
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 …
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.
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.
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.
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.…
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.
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.
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.
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: EH…
Medline Industries, LP
Updated Mar 19152 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…
Medline Industries, LP
Updated Mar 19380 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 19208 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 19413 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…
Medline Industries, LP
Updated Mar 19306 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…
Medline Industries, LP
Updated Mar 19340 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…
Medline Industries, LP
Updated Mar 19120 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 19632 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 19924 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…
Medline Industries, LP
Updated Mar 19160 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…
Medline Industries, LP
Updated Mar 19104 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.
The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation …
Hazard. The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.
The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation …
Hazard. The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.
Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled…
Medline Industries, LP
Updated Mar 16432 kits units
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol …
Hazard. Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Webcol Large Alcohol Prep Pads to be non-sterile following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled…
Medline Industries, LP
Updated Mar 16120 kits units
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol …
Hazard. Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Webcol Large Alcohol Prep Pads to be non-sterile following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
Halyard CARDIAC CATH PACK SAN23CARDQ kit. Model Number: DRCC36.
AVID Medical
Updated Mar 13180 kits units
Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection …
Hazard. Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Halyard NEURO IR PERIPHERAL (PS 64405) kit. Model Number: UINR44-01.
AVID Medical
Updated Mar 13204 kits units
Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection …
Hazard. Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection …
Hazard. Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Halyard CARDIAC CATH PACK kit. Model Number: EAMC1000-05, WAFB208-02.
AVID Medical
Updated Mar 13222 kits units
Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection …
Hazard. Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection …
Hazard. Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Halyard VA DETROIT CATH LAB PACK kit. Model Numbers: VMCD029.
AVID Medical
Updated Mar 1375 kits units
Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection …
Hazard. Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
LeadCare Ultra Blood Lead Test Kit; Catalog Number: 70-8098; The LeadCare Ultra kit is…
Magellan Diagnostics
Updated Mar 13284 units
Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary sam…
Hazard. Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test Systems. False positive lead results may cause delayed results and additional unnecessary testing.
LeadCare¿ Plus Blood Lead Test Kit; Catalog Number: 82-0004; The LeadCare¿ Plus kit is…
Magellan Diagnostics
Updated Mar 13136 units
Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary sam…
Hazard. Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test Systems. False positive lead results may cause delayed results and additional unnecessary testing.
During 3D acquisitions, lighter and darker patient images may be captured, which may result in less accurate 3D reconstruction. The variati…
Hazard. During 3D acquisitions, lighter and darker patient images may be captured, which may result in less accurate 3D reconstruction. The variation of brightness is a result of a constant unregulated medium dose and the angular change of patient diameter caused by rotational acquisition. This may result in unintentional low-dose radiation exposure to a patient.
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14433
Windstone Medical Packaging
Updated Mar 11475 units units
The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration …
Hazard. The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets utilized with BBMI s Infusomat Space Large Volume Pump, Outlook Pump and Vista Basic Pump due to potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers or other connecti…
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A
Windstone Medical Packaging
Updated Mar 11520 units units
The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration …
Hazard. The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets utilized with BBMI s Infusomat Space Large Volume Pump, Outlook Pump and Vista Basic Pump due to potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers or other connecti…
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994
Windstone Medical Packaging
Updated Mar 11380 units units
The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration …
Hazard. The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets utilized with BBMI s Infusomat Space Large Volume Pump, Outlook Pump and Vista Basic Pump due to potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers or other connecti…
Arjo Tenor mobile passive patient lift, Model Numbers KHA1000 US and KHA1010 US
ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Updated Mar 10119 units units
An internal component of the actuators in a certain production batch may not meet the required mechanical strength. This could result, in t…
Hazard. An internal component of the actuators in a certain production batch may not meet the required mechanical strength. This could result, in the worst case scenario, in a sudden loss of the actuator's ability to hold the load, leading to rapid and uncontrolled downward movement of the lifting arm.
ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ARTIS icono…
Siemens Medical Solutions USA
Updated Mar 9
During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been ob…
Hazard. During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing 0, an actual x-ray dose is applied to the patient.
ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system
Siemens Medical Solutions USA
Updated Mar 9
During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been ob…
Hazard. During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing 0, an actual x-ray dose is applied to the patient.
Philips Spectral CT on Rails. Model Number: 728334.
PHILIPS MEDICAL SYSTEMS
Updated Mar 73 systems units
Philips has identified three software issues: 1. During a continuous CT (CCT) scan, there is the potential that the Gantry could remain at …
Hazard. Philips has identified three software issues: 1. During a continuous CT (CCT) scan, there is the potential that the Gantry could remain at the current scan position after pressing Go. 2. Potential where the message of Previous Surview Exists Select Previous Surview? or should display but does not appear. 3. After performing Surview and planning the Brain Helical acquisition by setting Brain Area …
The product is a handheld ultraviolet-C germicidal wand and contains a combination of…
Uvlizer c/o RAIS INTERNATIONAL
Updated Mar 6334 units
In some foreseeable use conditions, the products can expose nearby persons to UVC radiation at levels significantly above limits recommende…
Hazard. In some foreseeable use conditions, the products can expose nearby persons to UVC radiation at levels significantly above limits recommended by international safety guidelines for skin and eye exposure.
Tornier HRS Max parts: 1. TORNIER HRS Max Tuberosity Body Lat Coat, Small, Cat. No…
Tornier
Updated Mar 5233 units
Affected products were incorrectly labeled as Tornier HRS Max products. These parts are compatible with the Tornier HRS system only, and ar…
Hazard. Affected products were incorrectly labeled as Tornier HRS Max products. These parts are compatible with the Tornier HRS system only, and are incompatible with the Tornier HRS Max system.
eTRAX Needle System Starter Kit 14G (for Aurora Trackers), Part Number 667-150
Civ Medical Instruments
Updated Mar 26 units units
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle t…
Hazard. There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
eTRAX Needle Sensor - 14G(for Aurora Trackers), Part Number 667-157
Civ Medical Instruments
Updated Mar 25 units units
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle t…
Hazard. There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
eTRAX Needle System Starter Kit 16G(for Aurora Trackers), Part Number 667-151
Civ Medical Instruments
Updated Mar 218 units units
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle t…
Hazard. There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
eTRAX Needle Sensor - 18G (for Aurora Trackers), Part Number 667-159
Civ Medical Instruments
Updated Mar 221 units units
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle t…
Hazard. There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
eTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-152
Civ Medical Instruments
Updated Mar 220 units units
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle t…
Hazard. There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
Whole-Body MR scanners used to produce images of the inside of the human body to aid diagnosis of disease may have been manufactured/servic…
Hazard. Whole-Body MR scanners used to produce images of the inside of the human body to aid diagnosis of disease may have been manufactured/serviced with ferrous (steel) fittings instead of non-ferrous (brass) fittings on the magnet rear and if system is accessed to perform service while the magnet is ramped, the magnetic field could attract the ferrous fittings potentially resulting in personnel injury.
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA)…
Medline Industries, LP
Updated Feb 27594 kits units
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during us…
Hazard. Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA)…
Medline Industries, LP
Updated Feb 2782 kits units
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during us…
Hazard. Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA)…
Medline Industries, LP
Updated Feb 27240 kits units
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during us…
Hazard. Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA)…
Medline Industries, LP
Updated Feb 27966 kits units
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during us…
Hazard. Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA)…
Medline Industries, LP
Updated Feb 27108 units units
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during us…
Hazard. Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA)…
Medline Industries, LP
Updated Feb 2720 kits units
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during us…
Hazard. Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA)…
Medline Industries, LP
Updated Feb 2760 kits units
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during us…
Hazard. Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA)…
Medline Industries, LP
Updated Feb 27439 kits units
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during us…
Hazard. Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA)…
Medline Industries, LP
Updated Feb 27762 units units
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during us…
Hazard. Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
2.4 VOLT TAP LOCKING SCREW TAP TO 90MM. Part Number: 03.424.124-US.
Synthes (USA) Products
Updated Feb 2577 units units
A full lot swap between VOLT Locking Screw Tap 03.424.124 lot 68900P9 and Cortical Screw Tap 03.424.126 lot 68982P8, resulting in the bones…
Hazard. A full lot swap between VOLT Locking Screw Tap 03.424.124 lot 68900P9 and Cortical Screw Tap 03.424.126 lot 68982P8, resulting in the bones taps having an incorrect thread.
All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and un…
Hazard. All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevat…
Custom temporomandibular joint implant may have contained incorrect patient-specific components that led to a poor fit of the implant, lead…
Hazard. Custom temporomandibular joint implant may have contained incorrect patient-specific components that led to a poor fit of the implant, leading to a right-sided open bite.
On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
On-X Life Technologies
Updated Feb 110 units
Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release s…
Hazard. Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications.
Brand Name: B. BRAUN MEDICAL INC. Product Name: BPSK, BLOCKJOCKS TRAY Model/Catalog…
B Braun Medical
Updated Jan 29210 units
B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL¿ Liquid Adhesive, that they have issued a …
Hazard. B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL¿ Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable.
Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK SHANDS JACKSONVILLE 20055717…
B Braun Medical
Updated Jan 29680 units
B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL¿ Liquid Adhesive, that they have issued a …
Hazard. B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL¿ Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable.
Brand Name: B. BRAUN MEDICAL INC Product Name: CESK NORTHSIDE ANESTHESIA TRAY…
B Braun Medical
Updated Jan 29280 units
B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL¿ Liquid Adhesive, that they have issued a …
Hazard. B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL¿ Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable.
Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK HARRIS METHODIST Model/Catalog…
B Braun Medical
Updated Jan 29690 units
B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL¿ Liquid Adhesive, that they have issued a …
Hazard. B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL¿ Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable.
Brand Name: B. BRAUN MEDICAL INC. Product Name: SESK UPMC DOUBLE CATHETER TRAY…
B Braun Medical
Updated Jan 29390 units
B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL¿ Liquid Adhesive, that they have issued a …
Hazard. B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL¿ Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable.
Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK RIVERSIDE HEALTH SYSTEM…
B Braun Medical
Updated Jan 29690 units
B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL¿ Liquid Adhesive, that they have issued a …
Hazard. B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL¿ Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable.
Brand Name: B. BRAUN MEDICAL INC. Product Name: LYNDON B JOHNSON HOSPITAL SPINAL EPID…
B Braun Medical
Updated Jan 29620 units
B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL¿ Liquid Adhesive, that they have issued a …
Hazard. B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL¿ Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable.
Software update is needed for laser systems, for topical infrared heating to provide temporary relief of minor muscle and joint pain, spasm…
Hazard. Software update is needed for laser systems, for topical infrared heating to provide temporary relief of minor muscle and joint pain, spasms, stiffness associated with minor arthritis, and to temporarily increase local blood circulation, operating at a maximum average power output of 70W, which is beyond the FDA cleared 60W.
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed …
Hazard. Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed …
Hazard. Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline Convenience Kits: 1) WMC I D PACK-LF, Model Number: DYNJ50806L
Medline Industries, LP
Updated Jan 732 units units
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed …
Hazard. Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed …
Hazard. Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed …
Hazard. Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed …
Hazard. Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Mint Lesion; Software Versions: 3.4.0 up to 3.9.5.;
Mint Medical
Updated Jan 7101 systems units
If the connection between a mint Lesion workstation and the mint Lesion server is interrupted while performing a read, in rare cases some i…
Hazard. If the connection between a mint Lesion workstation and the mint Lesion server is interrupted while performing a read, in rare cases some information may be lost or incorrectly linked to other patients.
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed …
Hazard. Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline Convenience Kits: 1) KIT GENERAL CLOSURE, Model Number: DYKMBNDL200A
Medline Industries, LP
Updated Jan 7108 units units
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed …
Hazard. Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline Convenience Kits: 1) DRAPE PACK-CHOICE, Model Number: DYNJ63118A
Medline Industries, LP
Updated Jan 772 units units
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed …
Hazard. Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed …
Hazard. Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline Convenience Kits: 1) ANCILLARY PACK-LF, Model Number:DYNJ0185290G; 2) OPEN HEART…
Medline Industries, LP
Updated Jan 7599 units units
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed …
Hazard. Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed …
Hazard. Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed …
Hazard. Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Yttrium-stabilized zirconium oxide discs for fixed all-ceramic dental restorations may have reduced or missing dentin layer and when used c…
Hazard. Yttrium-stabilized zirconium oxide discs for fixed all-ceramic dental restorations may have reduced or missing dentin layer and when used clinically in the patient's mouth there is an increased risk of fractures under functional stress.
it was found that in versions 1.3.7, 1.4.2, and 1.4.3, the Lock Screen and Limited Access Passcode Screen on the iLet graphical user interf…
Hazard. it was found that in versions 1.3.7, 1.4.2, and 1.4.3, the Lock Screen and Limited Access Passcode Screen on the iLet graphical user interface (GUI) include certain icons displayed in the status bar that are active, thereby allowing the user to bypass those screens when those icons on the status bar are pressed, allowing unauthorized access while the device is in Limited Access Mode. A Health Ris…
Philips Azurion 7M20, Model Numbers: 722079, 722224 with Software release R2.2.0, R2.2.1…
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Updated Dec 731 units units
During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after t…
Hazard. During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.
Philips Azurion 5M20, Model Numbers: 722228 with Software release R2.2.0, R2.2.1, R2.2.3…
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Updated Dec 751 units units
During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after t…
Hazard. During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.
Philips Azurion 7M12, Model Numbers: 722078, 722223 with Software release R2.2.0, R2.2.1…
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Updated Dec 7167 units units
During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after t…
Hazard. During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.
Philips Azurion 7B12/12, Model Numbers: 722067, 722225 with Software release R2.2.0…
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Updated Dec 751 units units
During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after t…
Hazard. During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.
Philips Azurion 3M12, Model Numbers: 722063, 722221 with Software release R2.2.0, R2.2.1…
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Updated Dec 716 units units
During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after t…
Hazard. During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.
Philips Azurion 3M15, Model Numbers: 722064, 722222 with Software release R2.2.0, R2.2.1…
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Updated Dec 727 units units
During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after t…
Hazard. During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.
Philips Azurion 5M12, Model Numbers: 722227 with Software release R2.2.0, R2.2.1, R2.2.3…
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Updated Dec 73 units units
During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after t…
Hazard. During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.
Philips Azurion 7B20/15, Model Numbers: 722068, 722226 with Software release R2.2.0…
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Updated Dec 7156 units units
During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after t…
Hazard. During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.
Automated Impella Controller (AIC) with the below product descriptions and corresponding…
Abiomed
Updated Jan 17625 units units
Retrospective submission for following issues identified: 1. Alarm failures, power-path faults, electrical-short risks, and inaccurate moto…
Hazard. Retrospective submission for following issues identified: 1. Alarm failures, power-path faults, electrical-short risks, and inaccurate motor-current sensing were identified in certain AIC consoles. 2. There is improper alignment between the purge cassette and the motor drive in the AIC. This can result in a piston block event and lead to the inability to complete priming of the purge system, requ…