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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.

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DateProductReasonClassFirm
Nov 17, 2023 VERO BIOTECH GENOSYL DS (Delivery System) Generation 3 Cassette, Model Number... Cassette did not meet an 1n-process flow criterion. Class II Vero Biotech, LLC
Sep 9, 2021 GENOSYL DS (Delivery System) console, for use as a vasodilator. Manufacturing defect involving reversal of the inlet and outlet gas lines, resulting in delivery ... Class I Vero Biotech, LLC
May 19, 2021 GENOSYL DS; Nitric Oxide Delivery System Combination Product NDA202860 Reports received of NO measured below desired dose during transition between primary console and ... Class I Vero Biotech, LLC

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.