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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
Feb 24, 2023 Iradimed Corporation MRidium MRI 1000 Series Infusion Sets, MRI Infusuui Set ... Certain Iradimed 1057 Syringe Adapter Sets, used with the MRidium MRI infusion pump, have a probl... Class II Iradimed Corporation
Jul 1, 2013 MRidium 1145 Dose Reduction System (DERS) drug library kit. (This is an opti... The Dose Error Reduction System (DERS) can indicate an incorrect recommended value for the rate v... Class I Iradimed Corporation
Aug 24, 2012 The brand name is MRidium Series 1000 MR Infusion Sets, Type 1058 MR IV Exten... Iradimed Corporation is recalling MRidium Series 1000 MR Infusion Sets, Type 1058 MR IV Extension... Class II Iradimed Corporation

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.