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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
Oct 21, 2016 5000 Series Freedom Drivers. Freedom Driver System for Temporary Total Artif... The Main Printed Circuit Board Assembly (PCBA) of the affected Freedom Drivers may fail and cause... Class I SynCardia Systems Inc.
Aug 6, 2015 Temporary Total Artificial Heart (TAH-t) with Freedom Driver System REF 5950... SynCardia Systems, Inc. is recalling Freedom Drivers due to a specific component of the drive mec... Class I SynCardia Systems Inc.
Dec 5, 2012 Companion External Battery, Part Number: 293001-001 The Companion External... Syncardia Systems is recalling the Companion External Batteries used with the Companion 2 Driver ... Class II SynCardia Systems 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.