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Browse Device Recalls

7 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 7 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 7 FDA device recalls.

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DateProductReasonClassFirm
May 4, 2023 BETTA LINK SR REUSABLE FISHMOUTH GUIDE-Intended for use in soft tissue to bon... Drill guides might bend when axial forces are applied by surgeon during procedure and result in p... Class II T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.
May 4, 2023 BETTA LINK SR KNOTLESS IMPLANT KIT-Intended for use in soft tissue to bone fi... Drill guides might bend when axial forces are applied by surgeon during procedure and result in p... Class II T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.
May 4, 2023 Betta Link LG Reusable ProngED Guide - Intended for use in soft tissue to bon... Drill guides might bend when axial forces are applied by surgeon during procedure and result in p... Class II T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.
May 4, 2023 BETTA LINK LG KNOTLESS IMPLANT KIT-Intended for use in soft tissue to bone fi... Drill guides might bend when axial forces are applied by surgeon during procedure and result in p... Class II T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.
May 4, 2023 BETTA LINK SR REUSABLE PRONGED GUIDE- Intended for use in soft tissue to bone... Drill guides might bend when axial forces are applied by surgeon during procedure and result in p... Class II T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.
May 4, 2023 Betta Link LG Reusable Fishmouth Guide-Intended for use in soft tissue to bon... Drill guides might bend when axial forces are applied by surgeon during procedure and result in p... Class II T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.
Jan 20, 2020 FlipCutter III Drill There is potential for the blister tray to be cracked causing the sterile barrier to be compromis... Class II T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.

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.