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Browse Device Recalls

3 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3 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 3 FDA device recalls.

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DateProductReasonClassFirm
Jul 3, 2024 GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circula... Devices were labeled with an expiration date of four years and ten days rather than the validated... Class II W.L. Gore & Associates, Inc.
Jan 19, 2024 GORE VIABIL Short Wire Biliary Endoprosthesis, Product labeled as (1) Catal... Devices without transmural drainage holes may be mislabeled as devices with transmural drainage h... Class II W.L. Gore & Associates, Inc.
Apr 5, 2021 GORE VIBIL Biliary Endoprosthesis: stents, drains and dilators for the biliar... The Gore post market surveillance team received a complaint that a GORE¿ VIABIL¿ Biliary Endopros... Class II W.L. Gore & Associates, 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.