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Browse Device Recalls

209 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 209 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 209 FDA device recalls in 2011.

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DateProductReasonClassFirm
Jan 18, 2011 Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 3 cc, w/Cr... Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRI... Class II Westmed Inc
Jan 18, 2011 Pulset Arterial Blood Gas (ABG) sampling kit. Modified Kit, Pulset, 3 cc, ... Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRI... Class II Westmed Inc
Jan 18, 2011 Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 3 cc, w/Cr... Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRI... Class II Westmed Inc
Jan 18, 2011 Pulset Arterial Blood Gas (ABG) sampling kit. Modified Kit, Pulset, 1 cc, ... Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRI... Class II Westmed Inc
Jan 11, 2011 Video Naso pharyngo Laryngoscopes This field action serves to retrospectively document the actions that were taken by Pentax to co... Class II Pentax of America Inc
Jan 11, 2011 Video Bronchoscope This field action serves to retrospectively document the actions that were taken by Pentax to co... Class II Pentax of America Inc
Jan 11, 2011 SteriGear Urinary Drain Bag with Fig Leaf Cover, 2000 ml, REF 10270, The Fig ... SteriGear notifed customers of circumstances in which The Fig Leaf urinary drain bag valve can cl... Class II SteriGear, LLC
Jan 11, 2011 Video Cytoscopes This field action serves to retrospectively document the actions that were taken by Pentax to co... Class II Pentax of America Inc
Jan 1, 2011 I-STAT EG7+ Cartridge Abbott Point of Care, Princeton, NJ. The i-Stat EG7 ... i-Stat EG7 cartridges may generate falsely depressed PCO2 results for samples above 26 mm hg when... Class II Abbott Point Of Care 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.