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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
Jun 3, 2016 Stryker Orthopaedics Trident Constrained Liner Inserter/Impactor Tip, 22 mm, ... Impactors do not meet the required sterility assurance level (SAL) of 10-6 when using the recomme... Class II Stryker Howmedica Osteonics Corp.
May 31, 2016 Pentax Video Bronchoscope Designed to be used with a Pentax Video Processor... Pentax America Inc. is recalling various bronchoscopes which contain an incorrect Operation and R... Class II Pentax of America Inc
May 31, 2016 Ultrasound Video Bronchoscope The EB-1970UK, Ultrasound Video Bronchoscope,... The EB-1970UK Ultrasound Video Bronchoscope shipped between the clearance date of April 2014 and... Class II Pentax of America Inc
May 20, 2016 K-wire, Smooth Double-pointed 0.8 x 90mm, a component of the METASURG Capture... The affected K-wires do not meet specification requirements. Specifically, a) K-wires were made o... Class II Integra LifeSciences Corp.
May 17, 2016 cobas¿ Liat Influenza A/B Quality Control Kit; For use with cobas¿ Liat Inf... Kit labeled with the incorrect expiration date. Class III Roche Molecular Systems, Inc.
May 13, 2016 MEGA¿ 7.5Fr. 30cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK... It was discovered during post-quarantine packaging on 2/16/2016 that the IFU for the STATLOCK She... Class II Datascope Corporation
May 10, 2016 TS Series Depth Gauge for Integra Ti6 Internal Fixation System 2.0/2.5mm Scre... As a result of an internal investigation of a non-conformance it has been determined: 1) Depth Ga... Class II Integra LifeSciences Corp.
May 9, 2016 cobas¿ Liat¿ Analyzer Device was released with default pcal/gain settings for photometers instead of the pcal/gain set... Class II Roche Molecular Systems, Inc.
May 9, 2016 Small Patient ECC Pack, REF BEQ-TOP 24100, Product Usage: The HLM Tubing Set... Custom Tubing Set BEQ-TOP-24100 (Small Patient ECC Pack) was identified as possessing a level of ... Class II Datascope Corporation
Apr 29, 2016 Cadence Size 5 Left Tibial Tray Implant, designed to treat ankle arthritis th... As a result of an internal review of all labeling for the Cadence System, it was determined that ... Class II Integra LifeSciences Corp.
Apr 28, 2016 Excelsior Disposable Syringe Heparin Lock Flush, USP syringe (5 mL Fill in 10... Certain lots of Heparin Lock Flush, USP Syringes (5 ml Fill in 10 ml Syringe) failed Anti-Factor ... Class II Excelsior Medical Corp
Apr 25, 2016 Breathe Right Clear, 30 ct. carton., UPC 7-57145-00246-7 (US), UPC 9-300673-8... Some cartons used in the secondary packaging of Breathe Right Clear, Large, 30 ct. Nasal Strips w... Class III GSK Consumer Healthcare
Apr 21, 2016 Musculoskeletal Transplant Foundation, AFT Diverted Tube (3/4/Filled), indica... AFT Diverted Tubes are being recalled due to a customer complaint involving one unit which had an... Class II Musculoskeletal Transplant Foundation, Inc.
Apr 15, 2016 POROUS PATELLA 32MM X 10MM - 00587806532 POROUS PATELLA 35MM X 10MM- 0058... 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 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

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.