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Browse Device Recalls

8 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 8 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 8 FDA device recalls.

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DateProductReasonClassFirm
Aug 13, 2014 Vapotherm Precision Flow,Disposable Patient Circuit PFH-DPC-High. For use wi... Disposable Patient Circuit that allows water to leak into the center gas lumen Class II Vapotherm, Inc.
Aug 13, 2014 Vapotherm Precision Flow,Disposable Patient Circuit PF-E-DPC-Low. PF-DPC-Lo... Disposable Patient Circuit that allows water to leak into the center gas lumen Class II Vapotherm, Inc.
Aug 13, 2014 Vapotherm Precision Flow,Disposable Patient Circuit PF-DPC-Low. For use wit... Disposable Patient Circuit that allows water to leak into the center gas lumen Class II Vapotherm, Inc.
Aug 13, 2014 Vapotherm Precision Flow,Disposable Patient Circuit PF-NODPC-Low. For use... Water may leak into the center gas lumen of the Patient Circuit Class II Vapotherm, Inc.
Aug 13, 2014 Vapotherm Precision Flow,Disposable Patient Circuit PFHDPC-Low. For use w... Disposable Patient Circuit that allows water to leak into the center gas lumen Class II Vapotherm, Inc.
Aug 13, 2014 Vapotherm Precision Flow, Disposable Patient Circuit PF-DPC-High. For use wi... Disposable Patient Circuit that allows water to leak into the center gas lumen Class II Vapotherm, Inc.
Aug 13, 2014 Vapotherm Precision Flow,Disposable Patient Circuit PF-E-DPC-High. For use w... Disposable Patient Circuit that allows water to leak into the center gas lumen Class II Vapotherm, Inc.
Aug 13, 2014 Vapotherm Precision Flow,Disposable Patient Circuit PFNODPC-High. For use w... Disposable Patient Circuit that allows water to leak into the center gas lumen Class II Vapotherm, 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.