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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.

Clear
DateProductReasonClassFirm
Apr 26, 2019 Inovo Single Luman Conserver Product Usage: This device is intended to re... The pressure gauge (manometer) may dislodge from the threaded insertion/mount, creating a leak. Class II Inovo, Inc
Oct 9, 2017 PURE OXYGEN CONCENTRATOR, CHAD Drive, Models CH5000 and CH5000S Post-market surveillance for Pure Stationary Oxygen Concentrators model CHSOOO and CHSOOOS demon... Class II Inovo, Inc
Jul 21, 2016 INOVO Purefill Oxygen Compressor Model PF1100 Is an oxygen refill machine ... Device can fail during operation. Class II Inovo, 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.