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Browse Device Recalls

59 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 59 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 59 FDA device recalls.

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DateProductReasonClassFirm
Apr 14, 2015 KimVent Turbo-Cleaning Closed Suction System for Adults, 10 F T-Piece (Produc... The internal blue flapper valve of certain KimVent Turbo-Cleaning Closed Suction System for Adult... Class II Halyard Health, Inc
Jan 16, 2015 KimVent Wet Pak, Closed Suction System for Adults, Double Swivel Elbow, 14 Fr... Defect: A hole or crack was found which may cause air to leak. Class II Halyard Health
Jan 16, 2015 KimVent Closed Suction System for Adults, Double Swivel Elbow, 14 Fr. Sterile... Defect: A hole or crack was found which may cause air to leak. Class II Halyard Health
Jan 16, 2015 KimVent Closed Suction System for Adults, Double Swivel Elbow, 12 Fr., Steril... Defect: A hole or crack was found which may cause air to leak. Class II Halyard Health
Nov 17, 2014 KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 8.5 mm, Distribut... The cuff inflation line may detach from the endotracheal tube during use. Class I Halyard Health
Nov 17, 2014 KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 7.0 mm, Distribut... The cuff inflation line may detach from the endotracheal tube during use. Class I Halyard Health
Nov 17, 2014 KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 9.0 mm, Distribut... The cuff inflation line may detach from the endotracheal tube during use. Class I Halyard Health
Nov 17, 2014 KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 8.0 mm, Distribut... The cuff inflation line may detach from the endotracheal tube during use. Class I Halyard Health
Nov 17, 2014 KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 7.5 mm, Distribut... The cuff inflation line may detach from the endotracheal tube during use. Class I Halyard Health

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.