Browse Device Recalls

2,093 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,093 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 2,093 FDA device recalls in NJ.

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DateProductReasonClassFirm
Mar 5, 2012 BD Vacutainer PST Gel and Lithium Heparin (LH); 83 Units; Plus Blood Collecti... BD is conducting a recall of the BD Vacutainer Plus Plastic Plasma Separator Tube (PST) with Ligh... Class III Becton Dickinson & Company
Mar 1, 2012 I-STAT PT/INR cartridge Abbott Point of Care Inc. Abbott Park, IL 60064 USA... The i-STAT PT/INR cartridges have the potential to exhibit incorrectly elevated results. Class II Abbott Point Of Care Inc.
Feb 24, 2012 Cobas KRAS Mutation Test for In Vitro Diagnostic Use Product Usage: Usage... During the real-time stability testing for the cobas KRAS Mutation Test on the commercial lot PO6... Class III Roche Molecular Systems, Inc.
Feb 20, 2012 enFlow IV Fluid Warmer (510k name: EFLOW IV FLUID WARMER, MODEL 100, EFLOW D... The EnFlow Warmer Strap does not meet the requirements of the biocompatibility standard (ISO 109... Class II Vital Signs Devices, a GE Healthcare Company
Feb 20, 2012 FLOW-I Anesthesia System The system is intended for use in administrating ... A technical alarm may be generated on the FLOW-i system when using the MAN/AUTO switch to change ... Class I Maquet Cardiovascular Us Sales, Llc
Feb 9, 2012 Integra¿ Advansys Medial Lisfranc Plate (MLP), Integra, 311 Enterprise Drive... Incorrect technique applied may cause potential rupture of the tibialis anterior tendon during su... Class II Integra LifeSciences Corp.
Feb 1, 2012 i-Stat cTnl cartridges Abbott Point of Care Inc. The i-Stat cTnl test i... The frequency of suppressed results for i-Stat cTnl, BNP and CK-MP cartridges is affected by atmo... Class II Abbott Point Of Care Inc.
Feb 1, 2012 COBAS AmpliPrep Sample Tube Input Barcode Clips, catalog number 03137040001. ... Certain lots of COBAS AmpliPrep (CAP) S-tube Input (Box of 12 bags 12x24 S-tube and 12x24 S-clip)... Class II Roche Molecular Systems, Inc.
Feb 1, 2012 i-Stat CK-MP cartridges Abbott Point of Care Inc. The i-Stat CKMB test is... The frequency of suppressed results for i-Stat cTnl, BNP and CK-MP cartridges is affected by atmo... Class II Abbott Point Of Care Inc.
Feb 1, 2012 i-Stat BNP cartridges Abbott Point of Care Inc. The i-Stat BNP test is a... The frequency of suppressed results for i-Stat cTnl, BNP and CK-MP cartridges is affected by atmo... Class II Abbott Point Of Care Inc.
Jan 26, 2012 Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Pr... Stryker has become aware that there exists a potential for breach of the sterile barrier of packa... Class II Stryker Howmedica Osteonics Corp.
Jan 13, 2012 Stryker AVS Navigator Trials 6mm-15mm Manufactured by: Stryker Spine SAS Z... Beginning in February 2011, Stryker Spine began receiving reports related to the shaft of the AVS... Class II Stryker Spine
Dec 29, 2011 Stryker Howmedica Osteonics Accolade Offset Rasp Handle Howmedica Osteonics ... Stryker Orthopaedics has become aware of the potential for the above noted Accolade Rasp Handle A... Class II Stryker Howmedica Osteonics Corp.
Dec 29, 2011 Stryker Orthopaedics, Definition PM Femoral Hip Stem Catalog Numbers 6265-3-0... Stryker Orthopaedics has become aware of the potential for cracking of the PMMA coating on their ... Class II Stryker Howmedica Osteonics Corp.
Dec 22, 2011 Arm and Hammer Spinbrush ProClean Sonic Recharge Color Wear Made in China. M... Church and Dwight plans to take actions to best convey to the public the potential small parts ch... Class II Church & Dwight Inc
Dec 22, 2011 Arm and Hammer Spinbrush Dual Action Powered Toothbrush Pro-Clean, various mo... Church and Dwight plans to take actions to best convey to the public the potential small parts ch... Class II Church & Dwight Inc
Dec 22, 2011 Arm and Hammer Spinbrush Pro Clean Sonic Recharge Made in China. Manufacture... Church and Dwight plans to take actions to best convey to the public the potential small parts ch... Class II Church & Dwight Inc
Dec 22, 2011 Arm and Hammer Spinbrush Pro Clean Sonic Tray BJS Made in China. Manufactur... Church and Dwight plans to take actions to best convey to the public the potential small parts ch... Class II Church & Dwight Inc
Dec 22, 2011 Arm and Hammer Spinbrush Dual Action Powered Toothbrush Spinbrush Pro Whiteni... Church and Dwight plans to take actions to best convey to the public the potential small parts ch... Class II Church & Dwight Inc
Dec 22, 2011 Tibial Punch Tower Assembly. Non-Sterile. CAT NO. 8000-1089. Howmedica Ost... Stryker Orthopaedics received a report indicating that a Tibial Keel Punch could not be inserted ... Class II Stryker Howmedica Osteonics Corp.
Dec 22, 2011 Arm and Hammer Spinbrush Pro White Sonic Toothbrush Made in China. Manufac... Church and Dwight plans to take actions to best convey to the public the potential small parts ch... Class II Church & Dwight Inc
Dec 22, 2011 Arm and Hammer Spinbrush Dual Action Powered Toothbrush Pro Clean Re-Charge ... Church and Dwight plans to take actions to best convey to the public the potential small parts ch... Class II Church & Dwight Inc
Dec 22, 2011 Arm and Hammer Spinbrush Pro White Sonic Crest Powered Toothbrush Made in Ch... Church and Dwight plans to take actions to best convey to the public the potential small parts ch... Class II Church & Dwight Inc
Dec 22, 2011 Arm and Hammer Spinbrush Pro Clean Sonic Color Wear Powered Toothbrush Made ... Church and Dwight plans to take actions to best convey to the public the potential small parts ch... Class II Church & Dwight Inc
Dec 22, 2011 Arm and Hammer Spinbrush Pro Clean Sonic Powered Toothbrush Made in China. M... Church and Dwight plans to take actions to best convey to the public the potential small parts ch... Class II Church & Dwight Inc
Oct 11, 2011 Integra Mozaik Putty 2.5cc, 5 cc, 10 cc Product Usage: The product is... The Instructions for Use {HIFU} {Putty Part Number 7700713001 and Strip Part Number 770151300 l f... Class II Integra LifeSciences Corp.
Oct 11, 2011 Integra Mozaik Strip 10 cc Product Usage: The product is a bone graft ... The Instructions for Use {IFU} {Putty Part Number 7700713001 and Strip Part Number 770151300l for... Class II Integra LifeSciences Corp.
Sep 8, 2011 iStat1 Analyzer Abbott Point of Care, Princeton, NJ 08540 Model 200. The ... 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 i-Stat Portable Clinical Analyzer; Abbott Point of Care, Princeton, NJ 08540 ... 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 Military Kit Portable Clinical Analyzer ; Abbott Point of Care, Princeton, N... 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 i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540 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 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.