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Browse Device Recalls

12 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 12 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 12 FDA device recalls.

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DateProductReasonClassFirm
Jul 11, 2012 Ventlab Premium Small Adult Resuscitator, Manufactured by: Ventlab Corporatio... Possible volume leakage through the inlet valve during compressions of the resuscitator bag. Class I Ventlab Corporation
Jul 11, 2012 Stat-Check Resuscitator, Adult Manual Emergency Resuscitator with A.C.E. /Sta... Possible volume leakage through the inlet valve during compressions of the resuscitator bag. Class I Ventlab Corporation
Jul 11, 2012 Ventlab Premium Small Child Resuscitator, Manufactured by: Ventlab Corporatio... Possible volume leakage through the inlet valve during compressions of the resuscitator bag. Class I Ventlab Corporation
Jul 11, 2012 AirFlow, Small Adult Resuscitator, AF5000 Series, Single use, Manufactured by... Possible volume leakage through the inlet valve during compressions of the resuscitator bag. Class I Ventlab Corporation
Jul 11, 2012 Breath Tech, Safe Spot Infant Resuscitator, BT2000 Series, Single use, Manufa... Possible volume leakage through the inlet valve during compressions of the resuscitator bag. Class I Ventlab Corporation
Jul 11, 2012 AirFlow, Infant Resuscitator, AF3000 Series, Single use, Manufactured by: Ven... Possible volume leakage through the inlet valve during compressions of the resuscitator bag. Class I Ventlab Corporation
Jul 11, 2012 Ventlab Rescue Med Infant Resuscitator, Manufactured by: Ventlab Corporation,... Possible volume leakage through the inlet valve during compressions of the resuscitator bag. Class I Ventlab Corporation
Jul 11, 2012 Adult Resuscitator, Pro-5000 Series, Single Patient Use, The Disposable ... Possible volume leakage through the inlet valve during compressions of the resuscitator bag. Class I Ventlab Corporation
Jul 11, 2012 Safe Spot Infant Resuscitator, Pro-1900 Series, Single Patient Use, The ... Possible volume leakage through the inlet valve during compressions of the resuscitator bag. Class I Ventlab Corporation
Jul 11, 2012 V*Care Resuscitator Infant Resuscitator, VN 3000 Series, Single use, Manufact... Possible volume leakage through the inlet valve during compressions of the resuscitator bag. Class I Ventlab Corporation
Jul 11, 2012 AirFlow Resuscitator, Adult Resuscitator, AF1000 Series, Single use, Manufact... Possible volume leakage through the inlet valve during compressions of the resuscitator bag. Class I Ventlab Corporation
Jul 11, 2012 Safe Spot Infant Resuscitator, SS3200 Series, Single Patient Use, Manufacture... Possible volume leakage through the inlet valve during compressions of the resuscitator bag. Class I Ventlab Corporation

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.