Browse Device Recalls

952 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 952 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 952 FDA device recalls in MI.

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DateProductReasonClassFirm
Aug 12, 2009 Safety monitor included with System 8000 Base The Sarns" Modular Perfusion... Terumo Cardiovascular Systems (Terumo CVS) received complaints from our Affiliate, Terumo Dubai ... Class II Terumo Cardiovascular Systems Corporation
Jul 21, 2009 Pointe Scientific CRP(HS) Wide Range Control Set and Pointe Scientific CRP(H... Individual vials of calibrator and standard were mislabeled; specifically the units on the vial l... Class III Medtest Holdings, 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.