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Browse Device Recalls

10 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 10 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 10 FDA device recalls.

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DateProductReasonClassFirm
Dec 3, 2021 Stryker CLAW II ORTHOLOC 3DSi Plate, Hole Qty: 4, 30mm, REF 40240430. The incorrect product is contained in the packaging. Class II Wright Medical Technology Inc
Dec 3, 2021 Wright Medical Technology Inc. CHARLOTTE MTP Hex Screw, Model #41122718, 2.7m... Incorrect product is contained in the packaging. Class II Wright Medical Technology, Inc.
Dec 3, 2021 Stryker DARCO Screw, Locking, Ti6A14V, REF DC2825016, 2.7mm x 16mm. The incorrect product is contained in the packaging. Class II Wright Medical Technology Inc
Nov 4, 2021 INBONE Total Ankle System, INBONE POLY INSERT SZ 2 10mm SULCUS The package contents and package labeling do not match. Class II Wright Medical Technology Inc
Nov 4, 2021 INBONE Total Ankle System, INBONE POLY INSERT SZ 2+ 14mm SULCUS The package contents and package labeling do not match. Class II Wright Medical Technology Inc
Aug 26, 2020 EVOLVE STEM 8.5MM Model # 496S085 Lack of sterility assurance Class II Wright Medical Technology Inc
Apr 9, 2020 WRIGHT INBONE Tibial Tray, Size: 2, Plasma Spray, Left, REF 2000252902 - Prod... One lot of INBONE Tibial Trays is missing the plasma coating. Class II Wright Medical Technology Inc
Sep 5, 2012 Hip Components: INSERT MOBILE "COLLEGIA" TAILLE 58*28, OT22C58, Lot Numbers... There may be inaccuracies on the labeled shelf life on all products packaged at the Toulon, Franc... Class II Wright Medical Technology Inc
Sep 5, 2012 Extremity Components: PROTHESE A EXPANSION COMPLETE D=6 LG 12 MM, Part Numbe... There may be inaccuracies on the labeled shelf life on all products packaged at the Toulon, Franc... Class II Wright Medical Technology Inc
Sep 5, 2012 Knee Components: ROTULE "913" D=32 , Part Number PGA00030, Lot Number X02383... There may be inaccuracies on the labeled shelf life on all products packaged at the Toulon, Franc... Class II Wright Medical Technology 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.