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Browse Device Recalls

2 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2 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 2 FDA device recalls.

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DateProductReasonClassFirm
Sep 17, 2025 MOSAIQ Oncology Information System Software Builds 3.1.3, 3.2.1, 3.2.2 & 3.... When appending a care plan that contains one or more wave medication orders, the occurrence and ... Class II ELEKTA SOLUTIONS AB
Sep 28, 2021 Elekta Medical Linear Accelerator (EMLA): Elekta Harmony Pro, REF 1555143;... There is a risk that the Diode D1 in the Modulator can fail in a destructive manner when removed ... Class II ELEKTA SOLUTIONS AB

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.