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Browse Device Recalls

15 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 15 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 15 FDA device recalls.

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DateProductReasonClassFirm
Nov 22, 2024 Cook Medical Biodesign Dural Graft, REF C-DUR-7X10, REF G31091, Sterile Incorrect version of IFU was used rather than updated version; and incorrect expiration date was ... Class II Cook Biotech, Inc.
Nov 22, 2024 Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, RE... Incorrect version of IFU was used rather than updated version; and incorrect expiration date was ... Class II Cook Biotech, Inc.
Nov 22, 2024 Cook Medical Biodesign Hiatal Hernia Graft, REF C-PHR-7X10-U, REF G31455, Ste... Incorrect version of IFU was used rather than updated version; and incorrect expiration date was ... Class II Cook Biotech, Inc.
Aug 7, 2024 Biodesign Fistula Plug C-FPS-0.4 - For implantation to reinforce soft tissue ... Products expire prior to the expiration date printed on the product labeling Class II Cook Biotech, Inc.
Aug 7, 2024 Biodesign Fistula Plug C-FPS-0.7 - For implantation to reinforce soft tissue ... Products expire prior to the expiration date printed on the product labeling Class II Cook Biotech, Inc.
Aug 7, 2024 Biodesign Recto-Vaginal Fistula Plug RVP-0.4 - For implantation to reinforce ... Products expire prior to the expiration date printed on the product labeling Class II Cook Biotech, Inc.
Aug 7, 2024 Biodesign Fistula Plug C-FPS-0.2-2 - For implantation to reinforce soft tissu... Products expire prior to the expiration date printed on the product labeling Class II Cook Biotech, Inc.
Aug 7, 2024 Biodesign Fistula Plug C-FPB-0.4 - For implantation to reinforce soft tissue ... Products expire prior to the expiration date printed on the product labeling Class II Cook Biotech, Inc.
Aug 7, 2024 Biodesign Fistula Plug C-FPS-0.4-2 - For implantation to reinforce soft tissu... Products expire prior to the expiration date printed on the product labeling Class II Cook Biotech, Inc.
Aug 7, 2024 Biodesign Fistula Plug C-FPS-0.2 - For implantation to reinforce soft tissue ... Products expire prior to the expiration date printed on the product labeling Class II Cook Biotech, Inc.
Aug 7, 2024 Biodesign Recto-Vaginal Fistula Plug RVP-0.7 - For implantation to reinforce ... Products expire prior to the expiration date printed on the product labeling Class II Cook Biotech, Inc.
Aug 7, 2024 Biodesign Fistula Plug C-FPS-0.7-2 - For implantation to reinforce soft tissu... Products expire prior to the expiration date printed on the product labeling Class II Cook Biotech, Inc.
Aug 7, 2024 Biodesign Recto-Vaginal Fistula Plug RVP-0.2 - For implantation to reinforce ... Products expire prior to the expiration date printed on the product labeling Class II Cook Biotech, Inc.
Aug 7, 2024 Biodesign Fistula Plug C-FPB-0.7 - For implantation to reinforce soft tissue ... Products expire prior to the expiration date printed on the product labeling Class II Cook Biotech, Inc.
Aug 7, 2024 Biodesign Inguinal Hernia Graft C-IHM-10X15 - To reinforce soft tissues in th... Products expire prior to the expiration date printed on the product labeling Class II Cook Biotech, Inc.

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.