Browse Device Recalls

103 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 103 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 103 FDA device recalls.

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DateProductReasonClassFirm
Jul 3, 2013 Medtronic MiniMed Paradigm Reservoirs, Model No: MMT-326A (1.8mL) and MMT-332... Medtronic is recalling certain lots of Medtronic MiniMed Paradigm Reservoirs MMT-326A (1.8mL) and... Class II Medtronic MiniMed
Jun 7, 2013 Medtronic MiniMed Paradigm Insulin Infusion Sets The Paradigm infusion set... Medtronic is recalling the Medtronic MiniMed Paradigm Medtronic is recalling the Medtronic MiniMe... Class I Medtronic MiniMed
Mar 22, 2013 Medtronic MiniMed Paradigm Insulin Infusion Pumps Model Numbers: MMT-511, ... Medtronic is recalling the Medtronic Paradigm Insulin Pump because the pump's drive support cap m... Class II Medtronic MiniMed

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.