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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
Jul 12, 2021 Gore Molding & Occlusion Balloon Catheter, REF Catalogue Number MOB37, SN XXX... Complaints received concerning Balloon Catheter leakage from the guidewire lumen and the y-hub du... Class II W. L. Gore & Associates Inc.
Jan 6, 2020 GORE¿ EXCLUDER¿ Iliac Branch Endoprosthesis (IBE) Firm has received reports of leading end catheter component separations. Class II W. L. Gore & Associates Inc.
Jan 6, 2020 GORE¿ EXCLUDER¿ AAA Endoprosthesis Firm has received reports of leading end catheter component separations. Class II W. L. Gore & Associates Inc.
Nov 18, 2019 Gore DrySeal Flex Introducer Sheath, Catalog #DSF1433, 33cm 14FR, Sterile. T... The devices were mislabeled with the incorrect product size resulting in 16Fr devices being label... 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.