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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
Mar 13, 2015 CareFusion Vital Signs LightWand Stylet. A device inserted into an endotra... Vital Signs Colorado (dba CareFusion) is recalling Vital Signs LightWand Stylet catalog numbers 3... Class II Vital Signs Colorado Inc.
Mar 13, 2015 Introduction Pack. A device inserted into an endotracheal tube to aid in the... Vital Signs Colorado (dba CareFusion) is recalling Vital Signs LightWand Stylet catalog numbers 3... Class II Vital Signs Colorado Inc.
Dec 26, 2013 Vital Signs Anesthesia Circuits The Ventilator Circuit is intended for use... A circuit in use was occluded by a blue port cap that was inadvertently attached to the circuit a... Class II Vital Signs Colorado Inc.
Aug 17, 2012 Vital Signs Disposable General Purpose 9 French Temperature Probe For monito... There is a potential for epistaxis during use of the Disposable General Purpose 9 French Temperat... Class II Vital Signs Colorado 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.