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Browse Device Recalls

4 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 4 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 4 FDA device recalls.

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DateProductReasonClassFirm
Dec 13, 2021 RESODURA matrix onlay 10.0 cm x 12.5 cm - indicated as dural substitutes for ... Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk o... Class II Collagen Matrix, Inc.
Dec 13, 2021 DuraMatrix-Onlay Collagen Dura Substitute Membrane 4 inches x 5 inches (10.0... Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk o... Class II Collagen Matrix, Inc.
Mar 19, 2019 Neomem Resorbable Collagen Membrane, 15 mm x 20 mm Reference Number (model):... Product was packaged in the wrong box; may have been placed inside a Neomem FLEXPLUS box instead ... Class II Collagen Matrix, Inc.
Aug 16, 2018 BioMend Extend, REF# 0142Z, Synthetic bone grafting material. There is a possibility that the product was packaged in the wrong box. Specifically, the product... Class III Collagen Matrix, 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.