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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
Aug 19, 2024 Selenia Dimensions/ 3Dimensions-Digital breast tomosynthesis Software Versio... Identified an issue with Selenia Dimensions 1.12.0 and 3Dimensions 2.3.0 system software when use... Class II Hologic Inc
Jun 13, 2024 Horizon X-Ray Bone Densitometer (DXA) Models: Horizon-A, Horizon-W, Horizo... Non-conformance pertains to electromagnetic compatibility requirements according to the internati... Class II Hologic Inc
Jun 27, 2017 Tomcat Instrument, REF ASY-07379, Hologic Incorporated, automated laboratory ... A Tomcat Instrument software anomaly that causes the pipettor arm to make physical contact with t... Class II Hologic, 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.