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Browse Device Recalls

4 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 4 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 4 FDA device recalls.

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DateProductReasonClassFirm
May 8, 2025 GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S Erroneous calibration values, potentially resulting in: as the device ages, oxygen purity will g... Class II Ohio Medical Corporation
Nov 16, 2021 Instavac Portable Suction Pump, Constant mode (model #757000, Instavac C) and... Increase in premature device failures Class II Ohio Medical Corporation
Aug 14, 2018 Portable Suction Pump, (a) Style 758010, Model CARE-E-VAC 3, Ohio Medical LLC... The care-e-vac(R)3 Battery/AC Powered Portable Aspirator battery terminal may come in contact wit... Class II Ohio Medical Corporation
Mar 12, 2018 Vacuum Regulator, Push-T-Set Intermittent Suction Unit (PTS-ISU) Product ... Final quality control testing was not completed before the devices were distributed.. Class II Ohio Medical Corporation

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.