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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

1,550 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,550 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 1,550 FDA device recalls in 2012.

Clear
DateProductReasonClassFirm
May 9, 2012 SARNS HIGH-FLOW AORTIC ARCH CANNULA: 6.5 MM (20 FR) 00 WITH 3/8" CONNECTOR, 1... During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Sy... Class II Terumo Cardiovascular Systems Corporation
May 9, 2012 24FR FLEX ART CANN NON STERILE. The Sarns High Flow Aortic Arch Cannula i... During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Sy... Class II Terumo Cardiovascular Systems Corporation
May 9, 2012 SARNS ANTEGRADE CARDIOPLEGIA CANNULA: ROOT INFUSION CANNULA WITH 12-GAUGE BLU... During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Ter... Class II Terumo Cardiovascular Systems Corporation
May 9, 2012 SARNS FLEXIBLE ARTERIAL CANNULA: 8.0 MM (24 FR) WITH 3/8" CONNECTOR,SUTURE RI... During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Sy... Class II Terumo Cardiovascular Systems Corporation
May 9, 2012 FX PACK Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Ve... During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Ter... Class II Terumo Cardiovascular Systems Corporation
May 9, 2012 SARNS HIGH-FLOW AORTIC ARCH CANNULA: 5.2 MM (16 FR) 00 WITH 3/8" CONNECTOR, 7... During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Sy... Class II Terumo Cardiovascular Systems Corporation
May 9, 2012 SARNS FLEXIBLE ARTERIAL CANNULA: 7.3 MM (22 FR) 00 WITH 3/8" CONNECTOR,SUTURE... During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Sy... Class II Terumo Cardiovascular Systems Corporation
May 9, 2012 X-COATED TRANSPLANT PACK Product Usage: The Sarns Cardioplegia Cannula an... During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Ter... Class II Terumo Cardiovascular Systems Corporation
May 9, 2012 Sarns Antegrade Cardioplegia Cannula: ROOT INFUSTION VENT CATHETER WITH 12 GA... During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Ter... Class II Terumo Cardiovascular Systems Corporation
May 8, 2012 ON-Q pump with ONDEMAND bolus button, ON-Q C-bloc with ONDEMAND; ON-Q C-bloc ... It was determined that in a small quantity of ON-Q pumps with ONDEMAND, the bolus button may not ... Class I I-Flow Corporation
May 8, 2012 Siemens Dimension Vista(R) System B12 Flex(R) Reagent Cartridge (K6442) B1... Siemens Healthcare Diagnostics has confirmed that the presence of Intrinsic Factor Blocking Antib... Class II Siemens Healthcare Diagnostics, Inc.
May 7, 2012 US-001 Rev A brochure is a two sided tri-fold printed marketing brochure desc... Non-Invasive Monitoring Systems Inc (NIMS) is voluntarily recalling promotional materials which c... Class II Non-Invasive Monitoring Systems, Inc.
May 7, 2012 CIVCO VirtuTRAX Instrument Navigator, Reusable non-sterile general purpose dr... The general purpose electromagnetic sensor was incorrectly calibrated causing potential variabili... Class II Civco Medical Instruments Inc
May 7, 2012 CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromag... The general purpose electromagnetic sensor was incorrectly calibrated causing potential variabili... Class II Civco Medical Instruments Inc
May 7, 2012 CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromag... The general purpose electromagnetic sensor was incorrectly calibrated causing potential variabili... Class II Civco Medical Instruments Inc
May 7, 2012 V Series Patient Monitors; Mindray DS USA, Inc. Product Usage: The V Seri... Mindray has identified two software anomalies contained in the V Series Monitoring System. There... Class II Mindray DS USA, Inc. d.b.a. Mindray North America
May 7, 2012 Lynx TM20 Torquemaster Low Speed Handpiece MTI Dental Products Sharp edge on the body/housing of the Lynx TM20 TorqueMaster Low Speed Handpiece. Class II MTI Precision Products LLC.
May 7, 2012 The Brilliance iCT and iCT SP are Computed Tomography X-Ray Systems intended ... Philips is issuing a software update (version 3.2.4) to the Brilliance iCT and iCT SP systems cur... Class II Philips Medical Systems (Cleveland) Inc
May 7, 2012 USA-002 Rev A brochure is a two sided tri-fold printed marketing brochure des... Non-Invasive Monitoring Systems Inc (NIMS) is voluntarily recalling promotional materials which c... Class II Non-Invasive Monitoring Systems, Inc.
May 7, 2012 CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromag... The general purpose electromagnetic sensor was incorrectly calibrated causing potential variabili... Class II Civco Medical Instruments Inc
May 7, 2012 CIVCO VirtuTRAX Instrument Navigator, Reusable non-sterile general purpose dr... The general purpose electromagnetic sensor was incorrectly calibrated causing potential variabili... Class II Civco Medical Instruments Inc
May 7, 2012 BeautyAngel Health Fitness Natural Collagen Stimulation Anti Aging For hum... The Beauty Angel was marketed without a 510k. Class II JK Products & Services, Inc
May 5, 2012 Robotic hand accessory to InMotion Arm, rehabilitation robot. Unsupervised patient could potentially mis-use the device and remove or rotate a protective cover... Class II Interactive Motion Technologies, Inc.
May 4, 2012 Tabs Professional Monitor, without wall bracket, Model 25023. Stanley Securi... The monitor may fail to sound an alarm Class II Stanley Security Solutions, Inc.
May 4, 2012 Hitachi Scenaria CT System Software Product Usage: The Scenaria system is... Hitachi discovered a software error in the Reconstruction Status function that creates a potentia... Class II Hitachi Medical Systems America Inc
May 4, 2012 Tabs Professional Voice + Monitor, includes one wall bracket, Model 25222. S... The monitor may fail to sound an alarm Class II Stanley Security Solutions, Inc.
May 4, 2012 Depuy Spine Side Fire Needles 13G X 4IN Side-Fire Needle, part of the Confide... Additional Instructions for Use and Surgical Technique for the Confidence Needle due to reports o... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
May 4, 2012 Depuy Spine Side Fire Needles 11G X 4IN, part of the Confidence Spinal Cement... Additional Instructions for Use and Surgical Technique for the Confidence Needle due to reports o... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
May 4, 2012 Tabs Professional Voice + Monitor, with wire bracket, Model 25223. Stanley S... The monitor may fail to sound an alarm Class II Stanley Security Solutions, Inc.
May 4, 2012 Safedraw Venous Close Loop System, Blood Sampling Set, packaged in a tyvek ba... Some of the kits may exhibit a potential defect with the pouch seal. The pouch issue may comprom... Class II Argon Medical Devices, Inc
May 4, 2012 Depuy Spine Side Fire Needles 13G X 6IN, part of the Confidence Spinal Cemen... Additional Instructions for Use and Surgical Technique for the Confidence Needle due to reports o... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
May 4, 2012 Tabs Professional Monitor, includes one wall bracket, Model 25022. Stanley S... The monitor may fail to sound an alarm Class II Stanley Security Solutions, Inc.
May 4, 2012 Depuy Spine Side Fire Needles 11G X 6IN Side-Fire Needle, part of the Confide... Additional Instructions for Use and Surgical Technique for the Confidence Needle due to reports ... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
May 4, 2012 Tabs Professional Monitor, without pull cord or wall bracket, Model 25025. S... The monitor may fail to sound an alarm Class II Stanley Security Solutions, Inc.
May 3, 2012 Arrow Two-Lumen Central Venous Catheterization Set with Blue FlexTip(R) ARROW... Lidstock of product does not contain chlorhexidine contraindication and contains wording "contain... Class I Arrow International Inc
May 1, 2012 Dual Incu i, (Atom Infant Incubator Model 100) Atom Medical Corporation 3-18-... There is a potential for the device's canopy to move unintentionally when using the incubator mod... Class II Atom Medical Corporation
May 1, 2012 NIDEK Medical NUVO LITE MODEL 520 STD, 115V - 60Hz - 330W. Oxygen Concentr... Capacitor failure may result in a fire hazard and loss of supplemental oxygen. Class I Nidek Medical Products Inc
May 1, 2012 NIDEK Medical NUVO LITE MODEL 925 OCSI, 230V - 50Hz - 300W. Oxygen Concent... Capacitor failure may result in a fire hazard and loss of supplemental oxygen. Class I Nidek Medical Products Inc
May 1, 2012 NIDEK Medical MARK5 NUVO / M5C5, 115 V ~60Hz - 410 W. Oxygen Concentrator. Capacitor failure may result in a fire hazard and loss of supplemental oxygen. Class I Nidek Medical Products Inc
May 1, 2012 NIDEK Medical NUVO LITE MODEL 525 OCSI, 115V -60Hz - 330W. Oxygen Concentr... Capacitor failure may result in a fire hazard and loss of supplemental oxygen. Class I Nidek Medical Products Inc
May 1, 2012 NIDEK Medical M5C5/ MARK5 NUVO/OCSI, 230 V~50/60 Hz -420 W. Oxygen Concent... Capacitor failure may result in a fire hazard and loss of supplemental oxygen. Class I Nidek Medical Products Inc
May 1, 2012 NIDEK Medical NUVO LITE MODEL 925 OCSI, 3LPM 230V - 60Hz - 280W. Oxygen Co... Capacitor failure may result in a fire hazard and loss of supplemental oxygen. Class I Nidek Medical Products Inc
May 1, 2012 NIDEK Medical MARK5 NUVO 8 STD, 115 V~60Hz - 500W. Oxygen Concentrator. Capacitor failure may result in a fire hazard and loss of supplemental oxygen. Class I Nidek Medical Products Inc
May 1, 2012 NIDEK Medical MARK5 NUVO 8 /OCSI, 230 V~50/60Hz - 420 W. Oxygen Concentrator. Capacitor failure may result in a fire hazard and loss of supplemental oxygen. Class I Nidek Medical Products Inc
May 1, 2012 NIDEK Medical M5C5/ MARK5 NUVO/STD, 230 V~50/60 Hz - 420 W. Oxygen Concent... Capacitor failure may result in a fire hazard and loss of supplemental oxygen. Class I Nidek Medical Products Inc
Apr 30, 2012 Rejuvenate Modular Stems Stryker Ireland Carrigtwohill Industrial Estate C... Stryker has updated the instruction for use (IFU) (product correction)for the ABGII Modular and R... Class II Stryker Howmedica Osteonics Corp.
Apr 30, 2012 Nextgen Complete Knee Solution Replacement Jaw for Use with Femoral and Provi... The design of the spring clip for the jaw assembly was updated in March 2011 due to fractures of ... Class II Zimmer Inc.
Apr 30, 2012 ABG II Modular Hip Stem Stryker Howmedica Osteonics Corp. Mahwah, NJ 07430 ... Stryker has updated the instruction for use (IFU) (product correction)for the ABGII Modular and R... Class II Stryker Howmedica Osteonics Corp.
Apr 30, 2012 Nextgen Complete Knee Solution Femoral and Provisional Impactor/ Extractor, R... The design of the spring clip for the jaw assembly was updated in March 2011 due to fractures of ... Class II Zimmer Inc.
Apr 30, 2012 Siemens Mobilett Mira mobile x-ray system Product Usage: Mobile x-ray s... During regular product monitoring, firm became aware of a potential issue with the Mobilett Mira ... Class II Siemens Medical Solutions USA, 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.