Browse Device Recalls

253 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 253 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 253 FDA device recalls.

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DateProductReasonClassFirm
Sep 19, 2011 Flush Port (used in almost all da Vinci instruments) Assists in cleaning t... Clarification of existing labeling information and operating procedures. Class II Intuitive Surgical, Inc.
Sep 19, 2011 da Vinci Si Surgeon Console. Intended to assist in the accurate Control of... Clarification of existing labeling information and operating procedures. Class II Intuitive Surgical, Inc.
Dec 11, 1930 Patient Cart used in conjunction with the da Vinci S surgical and SI System. ... Increased number of complaints regarding fluid entering the patient card base of the da Vinci S a... Class II Intuitive Surgical, 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.