Browse Device Recalls

2,062 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,062 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 2,062 FDA device recalls in NJ.

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DateProductReasonClassFirm
Sep 8, 2011 i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 2... Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a reca... Class II Abbott Point Of Care Inc.
Sep 8, 2011 Fuso Analyzer 300F; Abbott Point of Care, Princeton, NJ 08540 Model 200. T... Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a reca... Class II Abbott Point Of Care Inc.
May 12, 2011 DPM Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ... There is a software anomaly with the DPM Central Monitoring System where the trend data of one pa... Class II Mindray DS USA, Inc. d.b.a. Mindray North America
Apr 25, 2011 IO FiX X-Post Reamer, Extremity Medical, www.extremitymedical.com; Customer S... Product Event Reports revealed a broken reamer experienced intra-operatively. Pre-drilling was n... Class II Extremity Medical LLC
Apr 13, 2011 IO Fix IntraOsseous Fixation System; Extremity Medical. www.extremitymedical... Product Event Reports revealed that lag screw passes through washer (e.g. X-Post) intra-operatively. Class II Extremity Medical LLC
Mar 21, 2011 Stryker Reliance AL Implant Blocker (Various sizes) The SLIDE Implant Blo... Stryker Spine has received six reports regarding the breakage of one or more prongs at the extrem... Class II Stryker Spine
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 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.
Aug 11, 2010 DPM 6/7 Patient Monitor Manufactured in China for : Mindray DS USA, Inc. ... There is an issue with the DPM 6 and DPM 7 monitors where the following features may be unavailab... Class II Mindray DS USA, Inc. d.b.a. Mindray North America
Jul 1, 2005 Siemens Prisma 2K Hearing Aid Product Usage: A behind the ear (BTE) heari... Siemens became aware of an issue where an infant or child could open the tamper resistant battery... Class II Siemens Hearing Instruments, 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.