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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

2,093 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
Apr 15, 2016 00720504022 ACETAB.CUPW/SH,0DEG,22MMX40MM 00720504222 ACETAB.CUPW/SH,0DEG,2... Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal i... Class II Zimmer Trabecular Metal Technology, Inc.
Apr 15, 2016 REV. SHELL LINER 0D 28X48 00700504828 REV. SHELL LINER 10D 28X50 007010050... Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal i... Class II Zimmer Trabecular Metal Technology, Inc.
Apr 15, 2016 TM CR TIB SZ 3 C-H, 10MM- 00588604310 TM CR TIB SZ 3 C-H, 12 mm - 005886... Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal i... Class II Zimmer Trabecular Metal Technology, Inc.
Apr 15, 2016 TM MONO TIB STR GRN SZ 5 - 00588606510 TM MONO TIB STR GRN SZ 5 12MM - 00588... Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal i... Class II Zimmer Trabecular Metal Technology, Inc.
Apr 15, 2016 TM LPS TIB SZ 3 C/D, 10MM - 00588605310 TM LPS TIB SZ 3 C/D, 12MM - 005886... Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal i... Class II Zimmer Trabecular Metal Technology, Inc.
Apr 11, 2016 EVARREST Fibrin Sealant Patch, Manufactured by: Omrix Biopharmaceuticals, Ltd... Ethicon is recalling EVARREST Fibrin Sealant Patch because the characters "0-bad" were printed in... Class II Ethicon, Inc.
Apr 6, 2016 Confocal GI Scope Product Usage: Intended to provide optical visualizatio... Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bo... Class II Pentax Medical Company
Apr 6, 2016 Naso-Pharyngo-Laryngoscope Intended to provide optical visualization of, the... Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clip... Class II Pentax Medical Company
Apr 6, 2016 Gastroscope Intended to provide optical visualization of and therapeutic acc... Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clip... Class II Pentax Medical Company
Apr 6, 2016 Choledochoscope Intended to provide optical visualization of and therapeutic... Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clip... Class II Pentax Medical Company
Apr 6, 2016 Confocal GI Scope Intended to provide optical visualization of an therapeuti... Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clip... Class II Pentax Medical Company
Apr 6, 2016 Choledocho-Nephroscope Intended to provide optical visualization of and ther... Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clip... Class II Pentax Medical Company
Apr 6, 2016 Duodenoscope Product Usage: Intended to provide optical visualization of ... Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bo... Class II Pentax Medical Company
Apr 6, 2016 Cystoscope Intended to provide optical visualization of and therapeutic acce... Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clip... Class II Pentax Medical Company
Apr 6, 2016 Ureteroscope Intended to provide optical visualization of and therapeutic ac... Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clip... Class II Pentax Medical Company
Apr 6, 2016 Esophagoscope Gastrointestinal Tract. This anatomy includes, but is not rest... Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clip... Class II Pentax Medical Company
Apr 6, 2016 Gastroscope Product Usage: Intended to provide optical visualization of a... Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bo... Class II Pentax Medical Company
Apr 6, 2016 Ultrasound Gastroscope Intended to provide optical visualization of, ultraso... Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clip... Class II Pentax Medical Company
Apr 6, 2016 Ultrasound Bronchoscope Intended to provide optical visualization of, ultras... Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clip... Class II Pentax Medical Company
Apr 6, 2016 Signmoidoscope Intended to provide optical visualization of, therapeutic acc... Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clip... Class II Pentax Medical Company
Apr 6, 2016 Ultrasound Gastroscope Product Usage: Intended to provide optical visuali... Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bo... Class II Pentax Medical Company
Apr 6, 2016 Laryngo Stroboscope Product Usage Intended to provide optical visualization ... Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clip... Class II Pentax Medical Company
Apr 6, 2016 Small Bowel Scope Gastrointestinal Tract. This anatomy includes, but is not ... Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clip... Class II Pentax Medical Company
Apr 6, 2016 Colonoscope Product Usage: Intended to provide optical visualization of a... Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bo... Class II Pentax Medical Company
Apr 6, 2016 Intubation Scope Intended to provide optical visualization of, therapeutic a... Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clip... Class II Pentax Medical Company
Apr 6, 2016 Colonoscope Intended to provide optical visualization of and therapeutic acc... Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clip... Class II Pentax Medical Company
Apr 6, 2016 Bronchoscope Intended to provide optical visualization of and therapeutic ac... Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clip... Class II Pentax Medical Company
Apr 6, 2016 Signmoidoscope Product Usage: Intended to provide optical visualization o... Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bo... Class II Pentax Medical Company
Apr 5, 2016 cobas EGFR Mutation Test V2 Materials number CE-IVD: EGFR v2: 07248563190 ... During internal studies using contrived plasma specimens, several mutations (L8568R, Exon 19 dele... Class II Roche Molecular Systems, Inc.
Mar 25, 2016 Henry Schein Single Use Syringe Luer-Lock, 10 mL, Intended for use by health ... BD 10 mL Syringe Luer-Lok Tip with BD PrecisionGlide Needle 21G x 1 (0.8 mm x 25 mm) and Henry Sc... Class II Becton Dickinson & Company
Mar 25, 2016 Henry Schein Single Use Syringe Luer-Lock, 10 mL, Intended for use by heal... BD 10 mL Syringe Luer-Lok Tip with BD PrecisionGlide Needle 21G x 1 (0.8 mm x 25 mm) and Henry Sc... Class II Becton Dickinson & Company
Mar 18, 2016 1) 24 G x 0.75 in. BD Angiocath" Autoguard" shielded IV catheter (0.7 mm x 1... The device may have a defect in the catheter. In some instances this defect could result in cathe... Class II Becton Dickinson & Company
Mar 15, 2016 cobas¿ EGFR Mutation Test, v2 and cobas¿ cfDNA Sample Preparation Hungarian ... An error was found within the Hungarian translations of the cobas¿ EGFR Mutation Test v2 Instruct... Class II Roche Molecular Systems, Inc.
Mar 11, 2016 Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 15801 Neonatal Specia... There is a potential problem with the cuvette where failure of the cuvette would cause an error m... Class III Datascope Corporation
Mar 11, 2016 Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 5208 ECC SET, Part Numb... There is a potential problem with the cuvette where failure of the cuvette would cause an error m... Class III Datascope Corporation
Mar 11, 2016 Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 5909 14 Pack QPID, Pa... There is a potential problem with the cuvette where failure of the cuvette would cause an error m... Class III Datascope Corporation
Mar 11, 2016 Integra Meshed Dermal Regeneration Template 5 cmx 5 cm (2 in x 2in) Rx Only ... Integra's post QA release review of historical product release test results for Meshed IDRT produ... Class II Integra LifeSciences Corporation
Mar 9, 2016 Panorama Patient Monitoring Network Mindray DS USA The Panorama Patient Mo... Panorama Central Station including the work station View Station, View Station and the eGateway w... Class II Mindray DS USA, Inc. dba Mindray North America
Mar 7, 2016 Integra MicroFrance Monopolar and Bipolar Electrosurgical Instruments Reports relating to unintended patient or operator burns or operator electric shock for some of I... Class II Integra LifeSciences Corp.
Mar 7, 2016 Integra MicroFrance Monopolar and Bipolar Electrosurgical Instruments Reports relating to unintended patient or operator burns or operator electric shock for some of I... Class II Integra LifeSciences Corp.
Mar 3, 2016 Hand-Held Scanner USB IT3800 For sample identification and tracking when use... The hand-held barcode scanner model IT3800 used with the COBAS AmpliPrep instrument mis-identifie... Class II Roche Molecular Systems, Inc.
Feb 23, 2016 Custom Tubing Packs Custom tubing pack for oxygenators Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of expo... Class II Maquet Cardiovascular Us Sales, Llc
Feb 23, 2016 HLS Set Advanced with BIOLINE Coating Custom tubing packs for the oxygenator Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of expo... Class II Maquet Cardiovascular Us Sales, Llc
Feb 23, 2016 QUADROX-i oxygenators Custom tubing packs for the oxygenator Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of expo... Class II Maquet Cardiovascular Us Sales, Llc
Feb 23, 2016 Rotaflow Centrifugal Pump Custom tubing packs for the oxygenator Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of expo... Class II Maquet Cardiovascular Us Sales, Llc
Feb 22, 2016 Video Duodenoscope Pentax Medical learned of reports of carbapenem-resistant Enterobacteriaceae (CRE) infection at a... Class II Pentax Medical Company
Jan 29, 2016 Orapharma (Onpharma) Onset Mixing Pen Rx only, Product/Part Number 1054-02. ... It has been determined that the Onset Mixing Pen has an optimal use period of 18 months from star... Class II Valeant Pharmacueticals International
Jan 21, 2016 Stryker, T2 K-Wire with washer, 7.8 x 3 x 285mm Product Usage: Intended f... During a review of the packaging, it was determined that the seal integrity of the pouch may be d... Class II Stryker Howmedica Osteonics Corp.
Jan 21, 2016 Stryker, Gamma K-Wire 3.2x450 mm Product Usage: Intended for the temporar... During a review of the packaging, it was determined that the seal integrity of the pouch may be d... Class II Stryker Howmedica Osteonics Corp.
Jan 21, 2016 Stryker, Gamma K-Wire 3.2x450 mm, UNS-Thread Product Usage: Intended for ... During a review of the packaging, it was determined that the seal integrity of the pouch may be d... Class II Stryker Howmedica Osteonics Corp.

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.