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Vehicle Safety

Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

Consumer Safety

Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

Infrastructure

Bridge Safety624,000 bridge inspections Aviation Safety30,000+ NTSB aviation events Dam Safety92,600 dam safety records Water Safety433,000+ public water systems Railroad Safety438,000+ rail crossings Pipeline Safety8,800+ pipeline incidents State DashboardsSafety grades for all 50 states ZIP ReportAny 5-digit ZIP across 9 datasets

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Browse Device Recalls

2,057 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,057 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 2,057 FDA device recalls in NJ.

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DateProductReasonClassFirm
Apr 2, 2012 Stryker Orthopaedics Restoration Modular Cone Body Trials Stryker Ireland Ca... Stryker Orthopaedics has become aware of a burr, or a metal shaving, observed in the internal thr... Class II Stryker Howmedica Osteonics Corp.
Mar 30, 2012 Model 324JL On-Board Suction System Intended use: On-board suction system f... A shipment mix-up took place. Class III Impact Instrumentation, Inc.
Mar 27, 2012 CARDIOSAVE Intra-Aortic Balloon Pump An electromechanical system used to i... In the Cardiosave Intra-aortic Balloon Pump, there is a possibility that the coiled cord assembly... Class II Maquet Cardiovascular, LLC
Mar 23, 2012 Colgate Adult Motion Whitening Battery Toothbrush UPC 035000691507 Dist. b... Brush battery cap was forcibly blown off at the end of the brush handle. Class II Colgate Palmolive Company
Mar 23, 2012 Colgate 360 Replaceable Head Battery Powered Toothbrush Medium UPC03500068750... Brush battery cap was forcibly blown off at the end of the brush handle. Class II Colgate Palmolive Company
Mar 23, 2012 Colgate 360 Replaceable Head Battery Powered Toothbrush Soft UPC 03500068747 ... Brush battery cap was forcibly blown off at the end of the brush handle. Class II Colgate Palmolive Company
Mar 23, 2012 Colgate Adult Motion Battery Toothbrush UPC 035000686213 Dist. by Colgate... Brush battery cap was forcibly blown off at the end of the brush handle. Class II Colgate Palmolive Company
Mar 23, 2012 Colgate 360 Replaceable Head Battery Powered Bonus Twin Pack Toothbrush Soft ... Brush battery cap was forcibly blown off at the end of the brush handle. Class II Colgate Palmolive Company
Mar 22, 2012 Extremity Medical, IO FiX System Accessory. Catalog Number 101-00010. T... Lag screw measurement is short (approximately 5 mm) when using current screw measuring device (p/... Class II Extremity Medical LLC
Mar 19, 2012 Model 731 EMV+ Uni-Vent, Impact Instrumentation Inc., 27 Fairfield Place, Wes... Ten units of Model EMV+ Devices were shipped out in error before the verification and validation ... Class III Impact Instrumentation, Inc.
Mar 9, 2012 Orasure QuickFlu Rapid A+B Test Manufactured for OraSure Technologies, Inc B... There have been reports of dual positive (Flu A + Flu B positive) results being encountered. Class II Princeton Biomeditech Corp
Mar 9, 2012 Status Flu A + B Test Manufactured by Princeton Bio Meditech Corporation ... There have been reports of dual positive (Flu A + Flu B positive) results being encountered. Class II Princeton Biomeditech Corp
Mar 9, 2012 Poly stat Flu A & B Test Manufactured for Polymedco 510 Furnace Dock Roa... There have been reports of dual positive (Flu A + Flu B positive) results being encountered. Class II Princeton Biomeditech Corp
Mar 7, 2012 i-STAT cTnI cartridges Product Usage: The i-STAT cTnl test is an in vit... Abbott Point of Care has determined that i-Stat CTNL cartridges have the potential to exhibit inc... Class II Abbott Point Of Care Inc.
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

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.