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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
May 31, 2023 REF 218-1604-SP-10, Profile 0 4mm AutoDrive Screw Sterile Qty 10, Rx Only, St... Screws for osteotomies have contain an undersize screwhead which has the potential to pass throug... Class II Osteomed, LLC
May 31, 2023 REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, Sterile Screws for osteotomies have contain an undersize screwhead which has the potential to pass throug... Class II Osteomed, LLC
Oct 28, 2021 OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 RE... Due to consoles not in compliance with the latest electrical safety standards IEC 60601 and as a ... Class II Osteomed, LLC
Apr 2, 2020 OSTEOVATIONEX 3CC IMPACTFORMULA. REF/UDI: 390-0203/00813845020030 - Product U... Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characte... Class II Osteomed, LLC
Apr 2, 2020 OSTEOVATIONEX 5CC IMPACTFORMULA. REF/UDI: 390-0205/00813845020047 - Product U... Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characte... Class II Osteomed, LLC
Apr 2, 2020 OSTEOVATION 3CC IMPACTFORMULA. REF/UDI: 390-2103/00813845020078 - Product Usa... Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characte... Class II Osteomed, LLC
Apr 2, 2020 OSTEOVATIONEX 2CC INJECT FORMULA. REF/UDI: 390-0002/00813845020009 - Product ... Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characte... Class II Osteomed, LLC
Apr 2, 2020 OSTEOVATION RMX 10 CC Injectable. REF/UDI: 390-6002/ /00813845021099 - Produc... Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characte... Class II Osteomed, LLC
Apr 2, 2020 OSTEOVATION 10 CC IMPACT FORMULA. REF/UDI: 390-2110/ /00813845021092 - Produc... Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characte... Class II Osteomed, LLC
Apr 2, 2020 OSTEOVATION 5CC INJECT FORMULA. REF/UDI: 390-2005/00813845020054 - Product Us... Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characte... Class II Osteomed, LLC
Apr 2, 2020 OSTEOVATION 10CC INJECT FORMULA. REF/UDI: 390-2010/00813845020061 - Product U... Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characte... Class II Osteomed, LLC
Apr 2, 2020 OSTEOVATIONEX 5CC INJECT FORMULA. REF/UDI: 390-0005/00813845020023 - Product ... Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characte... Class II Osteomed, LLC
Apr 2, 2020 OSTEOVATION RMX Injectable BVF 5CC . REF/UDI: 390-6001/ /00813845021082 - Pro... Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characte... Class II Osteomed, LLC
Apr 2, 2020 OSTEOVATION 5CC IMPACTFORMULA. REF/UDI: 390-2105/00813845020085 - Product Usa... Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characte... Class II Osteomed, LLC
Apr 2, 2020 OSTEOVATIONEX 3CC INJECT FORMULA. REF/UDI: 390-0003/00813845020016 - Product ... Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characte... Class II Osteomed, LLC

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.