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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
Sep 22, 2020 ProVu Single Use Video Stylet with ET Tube, Part/Size: 038-990-080U/ 8.0, 038... When the video stylet cuff is over-inflated there is potential for occlusion of the corrugated se... Class I Flexicare Medical Ltd.
Nov 27, 2019 BriteBlade Pro Single-Use Fiber Optic Mac 3, CE01120, Do Not Re-use, Rx Only,... The firm has received reports that the spring/washer/bearing components in the block of the laryn... Class II Flexicare Medical Ltd.
Nov 27, 2019 BriteBlade Pro Single-Use Fiber Optic Handle and Blade Miller 2, CE 0120, Do ... The firm has received reports that the spring/washer/bearing components in the block of the laryn... Class II Flexicare Medical Ltd.
Nov 27, 2019 BriteBlade Pro Single-se Fiber Optic Miller 2, CE 0120, Do not Re-use, Rx Onl... The firm has received reports that the spring/washer/bearing components in the block of the laryn... Class II Flexicare Medical Ltd.
Nov 27, 2019 BriteBlade Pro Single-Use Fiber Optic Handle and Blade Mac 3, CE 0120, Do not... The firm has received reports that the spring/washer/bearing components in the block of the laryn... Class II Flexicare Medical Ltd.

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.