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Browse Device Recalls

53 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 53 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 53 FDA device recalls.

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DateProductReasonClassFirm
Sep 14, 2012 Gish 3/8 x 3/8" Straight Connector with Luer fitting, Item Numbers: EC2160B, ... Due to a molding irregularity, certain lots of connectors have the potential to leak fluid or ent... Class II Sorin Group USA, Inc.
Sep 14, 2012 Gish 3/8 x 1/2" Reducer Connector with Luer fitting, Item Numbers: EC2180S, L... Due to a molding irregularity, certain lots of connectors have the potential to leak fluid or ent... Class II Sorin Group USA, Inc.
Aug 15, 2012 Stockert Heater-Cooler 3T; Item Number 16-02-8, H3T/240V/60Hz ; 16-02-82, H3T... On August 15, 2012, Sorin informed consignees via letter of changes made to create Version 12 of ... Class II Sorin Group USA, 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.