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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
Jul 25, 2024 Vivo 45 LS, pressure and volume ventilator capable of delivering continuous o... There is a potential for short term (<7 days) elevated levels of formaldehyde emitted from the de... Class I Breas Medical, Inc.
Oct 13, 2023 with Notch 22M/15F sold as part of Breas Medical MPV circuit 2 pc Kits: 0060... Produced with unintended open slits on the side of the mouthpiece body, may result in insufficien... Class II Breas Medical, Inc.
Jun 2, 2022 Vivo 45LS Ventilator- intended to provide continuous or intermittent ventilat... A forced shutdown of one of the processors did not generate a watch dog alarm, would develop into... Class II Breas Medical, Inc.
Mar 21, 2022 Breas Ventilator Trolley with the Vivo 50/60/65 and Vivo 45LS ventilator mode... Ventilator mounting brackets for the Vivo 50/60/65 and Vivo 45LS ventilator models can become det... Class II Breas Medical, Inc.
Jan 28, 2020 Protective Cover Vivo 55/65 (Used for Vivo 50/65), Part No. 006344. It is an ... The outlet hole of the exhalation valve control pressure tube on the ventilator may become obstru... Class II Breas Medical, 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.