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Browse Device Recalls

5 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5 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 5 FDA device recalls.

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DateProductReasonClassFirm
Dec 3, 2014 Rotoprone Therapy System. The Rotoprone Therapy System is an advanced pati... The recalled devices labeling and instructions for use contain unapproved medical claims. Class II Arjo Hospital Equipment AB
Dec 3, 2014 RotoRest Delta Advanced Therapy System. The RotoRest Delta Advanced Kineti... The recalled devices labeling and instructions for use contain unapproved medical claims. Class II Arjo Hospital Equipment AB
Dec 3, 2014 TriaDyne Proventa Critical Care Therapy System. The TriaDyne Proventa Crit... The recalled devices labeling and instructions for use contain unapproved medical claims. Class II Arjo Hospital Equipment AB
Sep 1, 2014 Pressure IQ Evolve Mattress; Non-powered mattress replacement system. Inte... The firm received complaints regarding multiple mattresses were showing failures resulting in pre... Class II Arjo Hospital Equipment AB
Mar 17, 2014 ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients... There is a low but existing entrapment risk for a patient being treated on the Contoura 1000 and ... Class II Arjo Hospital Equipment 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.