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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
Oct 30, 2017 CP5 Centrifugal Pump, made up of the drive unit, the emergency system and the... Possibility that the automatic line closure by the Electronic Remote-Controlled (ERC) clamp after... Class II Sorin Group Deutschland GmbH
Dec 4, 2013 CP5 centrifugal pump system Product Usage: The Stockert S5/ Sorin C5 Syst... Sorin is initiating a field correction on S5/C5 Heart-lung machine and CP5 centrifugal pump syste... Class II Sorin Group Deutschland GmbH
Dec 4, 2013 S5/C5 Heart-lung machine Product Usage: The StOckert S5/ Sorin C5 System ... Sorin is initiating a field correction on S5/C5 Heart-lung machine and CP5 centrifugal pump syste... Class II Sorin Group Deutschland GmbH
Sep 24, 2013 S5 Heart-lung machine, Stockert S5 System. Catalogue No: 48-30/40/50-00. ... Sorin Group is recalling certain models of S5 Perfusion Systems due to malfunction of cardioplegi... Class II Sorin Group Deutschland GmbH

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.