Browse Device Recalls

960 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 960 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 960 FDA device recalls.

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DateProductReasonClassFirm
Jul 29, 2020 PROTEXIS Latex Micro Surgical Gloves Size 8.5 - Product Usage: This surgeon s... A degradation defect was found that could lead to holes and donning tears at the folding area aro... Class II Cardinal Health 200, LLC
Jul 29, 2020 PROTEXIS Latex Micro Surgical Gloves Size 6.0 - Product Usage: This surgeon s... A degradation defect was found that could lead to holes and donning tears at the folding area aro... Class II Cardinal Health 200, LLC
Jul 27, 2020 Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation 7Fr 34cc IAB Kit, P... Potential Endotoxin Contamination Class II Datascope Corporation
Jul 27, 2020 Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 40cc IAB Kit P/N... Potential Endotoxin Contamination Class II Datascope Corporation
Jul 27, 2020 Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation 7Fr 40cc IAB Kit P/N... Potential Endotoxin Contamination Class II Datascope Corporation
Jul 27, 2020 Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 40cc IAB ... Potential Endotoxin Contamination Class II Datascope Corporation
Jul 27, 2020 Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 7.5 Fr 40cc IAB... Potential Endotoxin Contamination Class II Datascope Corporation
Jul 27, 2020 Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 30cc IAB (... Potential Endotoxin Contamination Class II Datascope Corporation
Jul 27, 2020 Datascope Intra-Aortic Balloon Catheters (IABs)-MEGA 7.5Fr 40cc IAB Kit P/N: ... Potential Endotoxin Contamination Class II Datascope Corporation
Jul 27, 2020 Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 34cc IAB (Japan)... Potential Endotoxin Contamination Class II Datascope Corporation
Jul 27, 2020 Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 40cc IAB (... Potential Endotoxin Contamination Class II Datascope Corporation
Jul 27, 2020 Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 7.5Fr 30cc IAB, P/N: 0... Potential Endotoxin Contamination Class II Datascope Corporation
Jul 27, 2020 Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 35cc IAB (... Potential Endotoxin Contamination Class II Datascope Corporation
Jul 27, 2020 Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 25cc IAB Kit P/... Potential Endotoxin Contamination Class II Datascope Corporation
Jul 27, 2020 Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 8Fr 50cc IAB Ki... Potential Endotoxin Contamination Class II Datascope Corporation
Jul 27, 2020 Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 8Fr 50cc IAB Kit P/N: 068... Potential Endotoxin Contamination Class II Datascope Corporation
Jul 27, 2020 Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 35cc IAB ... Potential Endotoxin Contamination Class II Datascope Corporation
Jul 27, 2020 Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 40cc IAB (Japan)... Potential Endotoxin Contamination Class II Datascope Corporation
Jul 27, 2020 Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 34cc IAB Kit P/N:... Potential Endotoxin Contamination Class II Datascope Corporation
Jul 6, 2020 Gentueri Viral Transport Medium Kit with 8cm Breakpoint Swab Kits failed sterility testing and showed evidence of contamination. Class II Gentueri Inc
Jun 19, 2020 SafeStep Huber Needle Set; Catalog Numbers LH-0029 (UDI 00801741066160), LH-... Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. De... Class II Becton Dickinson & Company
Jun 19, 2020 PowerLoc MAX Power Injectable Infusion Set with GuardIVa Antimicrobial Hemost... Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. De... Class II Becton Dickinson & Company
Jun 19, 2020 SafeStep Huber Needle Set AllPoints Port Access System; Catalog Numbers AN152... Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. De... Class II Becton Dickinson & Company
Jun 19, 2020 SafeStep Huber Needle Set myPICK Port Access Kit; Catalog Numbers CPA00020A (... Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. De... Class II Becton Dickinson & Company
Jun 19, 2020 SafeStep Huber Needle Set with Y Injection Site and Medegen Needleless Inject... Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. De... Class II Becton Dickinson & Company
Jun 19, 2020 PowerLoc MAX Power Injectable Infusion Set AllPoints Port Access System; Cata... Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. De... Class II Becton Dickinson & Company
Jun 19, 2020 PowerLoc MAX Power-Injectable Infusion Set myPICK Port Access Kit; Catalog Nu... Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. De... Class II Becton Dickinson & Company
Jun 19, 2020 SafeStep Huber Needle Set Port Access Kit; Catalog Numbers PA-0029 (UDI 00801... Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. De... Class II Becton Dickinson & Company
Jun 19, 2020 SafeStep Huber Needle Set with GuardIVa Antimicrobial Hemostatic Dressing Por... Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. De... Class II Becton Dickinson & Company
Jun 19, 2020 PowerLoc MAX Power Injectable Infusion Set; Catalog Numbers 0131910 (UDI 0080... Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. De... Class II Becton Dickinson & Company
Jun 19, 2020 SafeStep Huber Needle Set with GuardIVa Antimicrobial Hemostatic Dressing; Ca... Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. De... Class II Becton Dickinson & Company
Jun 19, 2020 PowerLoc MAX Power Injectable Infusion Port Access Kit; Catalog Numbers 21319... Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. De... Class II Becton Dickinson & Company
Jun 3, 2020 MagNA Pure 96 Instrument, clinical sample concentrator, Material number 06541... When using Sample Transfer protocol version 3.0, the drop catcher is not activated on the MagNA P... Class II Roche Molecular Systems, Inc.
Apr 7, 2020 Abbott Accelerator a3600, ARCHITECT cSystem c8000/c16000 Interface Module, Pa... When analyzer sample carousel lid remains open or manual process is too long, Module timeout expi... Class II Inpeco S.A.
Apr 7, 2020 Inpeco FlexLab, ARCHITECT cSystem c8000/c16000 Interface Module, Part Numbers... When analyzer sample carousel lid remains open or manual process is too long, Module timeout expi... Class II Inpeco S.A.
Mar 4, 2020 STA - Deficient VIII, Product Code: 00725. STA - Deficient VIII is an immuno... A risk of sample-to-sample cross-contamination of Emicizumab for factor VIII assays on Stago inst... Class II Diagnostica Stago, Inc.
Feb 24, 2020 LivaNova Heater-Cooler System 3T - Product Usage: The Heater-Cooler 3T System... The firm is providing validated cleaning and disinfection instructions in their revised operating... Class II LivaNova USA Inc.
Feb 18, 2020 Custom procedure trays containing medical components needed to facilitate pat... The medical procedure trays contain one or more recalled surgical gowns. The gowns were manufact... Class II Avid Medical, Inc.
Feb 18, 2020 Custom procedure trays containing medical components needed to facilitate pat... The medical procedure trays contain one or more recalled surgical gowns. The gowns were manufact... Class II Avid Medical, Inc.
Feb 18, 2020 Custom procedure trays containing medical components needed to facilitate pat... The medical procedure trays contain one or more recalled surgical gowns. The gowns were manufact... Class II Avid Medical, Inc.
Feb 18, 2020 Custom procedure trays containing medical components needed to facilitate pat... The medical procedure trays contain one or more recalled surgical gowns. The gowns were manufact... Class II Avid Medical, Inc.
Feb 18, 2020 Custom procedure trays containing medical components needed to facilitate pat... The medical procedure trays contain one or more recalled surgical gowns. The gowns were manufact... Class II Avid Medical, Inc.
Feb 18, 2020 Custom procedure trays containing medical components needed to facilitate pat... The medical procedure trays contain one or more recalled surgical gowns. The gowns were manufact... Class II Avid Medical, Inc.
Feb 18, 2020 Custom procedure trays containing medical components needed to facilitate pat... The medical procedure trays contain one or more recalled surgical gowns. The gowns were manufact... Class II Avid Medical, Inc.
Feb 18, 2020 Custom procedure trays containing medical components needed to facilitate pat... The medical procedure trays contain one or more recalled surgical gowns. The gowns were manufact... Class II Avid Medical, Inc.
Feb 18, 2020 Custom procedure trays containing medical components needed to facilitate pat... The medical procedure trays contain one or more recalled surgical gowns. The gowns were manufact... Class II Avid Medical, Inc.
Feb 4, 2020 DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the fo... Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and u... Class II Deroyal Industries, Inc. Lafollette
Feb 4, 2020 DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the fo... Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and u... Class II Deroyal Industries, Inc. Lafollette
Feb 4, 2020 DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the fo... Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and u... Class II Deroyal Industries, Inc. Lafollette
Feb 4, 2020 DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the fo... Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and u... Class II Deroyal Industries, Inc. Lafollette

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.