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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

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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.

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DateProductReasonClassFirm
Jun 21, 2012 Terumo Advanced Perfusion System 1 System 1 Base, 220/240V. The Terumo ... Terumo Cardiovascular Systems has received reports of several issues that manifest themselves as ... Class II Terumo Cardiovascular Systems Corporation
Jun 21, 2012 Terumo Advanced Perfusion System 1 System 1 Base, 100/120V. The Terumo ... Terumo Cardiovascular Systems has received reports of several issues that manifest themselves as ... Class II Terumo Cardiovascular Systems Corporation
Jun 21, 2012 Focal SIM Planning of radiation therapy Incorrect patient shift directions when the Setup reference dialog is printed out when the DICOM ... Class II Elekta, Inc.
Jun 20, 2012 Philips HeartStart MRx monitor/defibrillators Models: M3535A, M3536A, M3536M... HeartStart MRx Unexpected Pads/Paddles ECG Failure Class II Philips Healthcare Inc.
Jun 20, 2012 Siemens syngo.plaza Radiological Image Processing System Usage: Radiologic... Firm has become aware of an unintended behavior when using syngo.plaza and issued an Update Instr... Class II Siemens Medical Solutions USA, Inc
Jun 20, 2012 Select Medical Products Vinyl Powder-Free Exam Gloves, Medium Model # 6370 an... Gulf South Medical Supply recalled their Select Medium and Large size Vinyl Exam Gloves because t... Class II Gulf South Medical Supply Inc
Jun 20, 2012 Philips HeartStart MRx monitor/defibrillators Models: M3535A and M3536A, M35... Therapy Cable Connection wear may lead to a malfunction in detection of defibrillation pads/paddl... Class II Philips Healthcare Inc.
Jun 20, 2012 Philips HeartStart MRx M3536A Defibrillator/Monitor with Software R.03.03 ... Defibrillator/monitor cannot analyze an ECG report during acquisition of 12 lead ECG Class II Philips Healthcare Inc.
Jun 20, 2012 System 8000 Base Product Usage: The Sarns Modular Perfusion System 8000 ... During a retrospective review of complaint events, TCVS identified on 06/15/12 that three (3) Sa... Class III Terumo Cardiovascular Systems Corporation
Jun 19, 2012 Stryker brand Arthroscope and Hardware Set Tray (sterilization tray); Model/P... The gravity steam, Ethylene Oxide (EO) and STERRAD 100S sterilization methods are being removed f... Class II Stryker Endoscopy
Jun 19, 2012 STERRAD 100S Cassette, Batch # 12A077. The STERRAD 100S and STERRAD NX ste... Advanced Sterilization Products (ASP) is recalling (removing) the Sterrad 100S and Sterrad NX Sys... Class III Advanced Sterilization Products
Jun 19, 2012 EOS X-ray Medical Diagnostic , X-ray Equipment System Digital Radiography ... It was discovered of several generator failures of the EOS System due to failure of its anode con... Class II Eos Imaging Inc
Jun 19, 2012 STERRAD NX Cassette, Batch # 12A078. The STERRAD 100S and STERRAD NX steri... Advanced Sterilization Products (ASP) is recalling (removing) the Sterrad 100S and Sterrad NX Sys... Class III Advanced Sterilization Products
Jun 19, 2012 Sterile Access & Return Line Set, 36" Length, Part # UM-872-36. Intended... The recalled product leaks at the connection site. Class II Molded Products Inc
Jun 19, 2012 CareFusion EnVe Ventilator Designed for use on patients who require respir... CareFusion identified that the EnVe Ventilator may not hold the set Positive End Expiratory Press... Class I CareFusion 203, Inc.
Jun 18, 2012 Sarns Modular Perfusion System 9000, 100V with color screen. The Sarns Per... Terumo Cardiovascular Systems has received several reports of malfunctions of the Air Bubble Dete... Class II Terumo Cardiovascular Systems Corporation
Jun 18, 2012 Terumo Advanced Perfusion System 1. System 1 base 100/120V. The Terumo Ad... Terumo Cardiovascular Systems has received several reports of malfunctions of the Air Bubble Dete... Class II Terumo Cardiovascular Systems Corporation
Jun 18, 2012 Sarns Modular Perfusion System 8000 base, 5 pump 100V. he Sarns Modular Pe... Terumo Cardiovascular Systems has received several reports of malfunctions of the Air Bubble Dete... Class II Terumo Cardiovascular Systems Corporation
Jun 18, 2012 superDimension Systems AAS00016-xx with Software Version 4.0-4.9. Indicate... superDimension, Inc., is conducting a recall of certain superDimension Systems operating Software... Class II superDimension, Inc
Jun 18, 2012 Sarns Modular Perfusion System 8000 base, 4 pump 115V. The Sarns Modular P... Terumo Cardiovascular Systems has received several reports of malfunctions of the Air Bubble Dete... Class II Terumo Cardiovascular Systems Corporation
Jun 18, 2012 Sarns Modular Perfusion System 9000, 220/240V with color screen. The Sarns... Terumo Cardiovascular Systems has received several reports of malfunctions of the Air Bubble Dete... Class II Terumo Cardiovascular Systems Corporation
Jun 18, 2012 Sarns Modular Perfusion System 8000 base, 5 pump 220/240V. The Sarns Modul... Terumo Cardiovascular Systems has received several reports of malfunctions of the Air Bubble Dete... Class II Terumo Cardiovascular Systems Corporation
Jun 18, 2012 MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for ... Synthes is initiating a Medical Device Labeling Correction following a detailed review of the cur... Class II Synthes USA HQ, Inc.
Jun 18, 2012 Sarns Modular Perfusion System 8000 base, 5 pump 115V. The Sarns Modular P... Terumo Cardiovascular Systems has received several reports of malfunctions of the Air Bubble Dete... Class II Terumo Cardiovascular Systems Corporation
Jun 18, 2012 Terumo Advanced Perfusion System 1. System 1 base 220/240V. The Terumo Ad... Terumo Cardiovascular Systems has received several reports of malfunctions of the Air Bubble Dete... Class II Terumo Cardiovascular Systems Corporation
Jun 18, 2012 Advanta 2 Bed. The Advanta 2 Bed is intended for low to moderate acuity pa... During an evaluation of Advanta 2 siderail samples returned from the field it was found that the ... Class II Hill-Rom, Inc.
Jun 18, 2012 Safe N Simple No-Sting Skin Barrier Film, Ostomy Skin Barrier Wipe, SNS00807 The firm received a customer complaint of observed spots on the wipes. The manufacturer confirmed... Class II Safe N Simple, LLC
Jun 18, 2012 Sarns Modular Perfusion System 8000 base, 4 pump 100V. The Sarns Modular P... Terumo Cardiovascular Systems has received several reports of malfunctions of the Air Bubble Dete... Class II Terumo Cardiovascular Systems Corporation
Jun 18, 2012 Varian brand Varian Eclipse Treatment Planning System for radiotherapy; Model... Varian has identified an anomaly with the Eclipse Treatment Planning (for radiotherapy treatments... Class II Varian Medical Systems, Inc. Oncology Systems
Jun 18, 2012 Sarns Modular Perfusion System 8000 base, 4 pump 220/240V. The Sarns Modul... Terumo Cardiovascular Systems has received several reports of malfunctions of the Air Bubble Dete... Class II Terumo Cardiovascular Systems Corporation
Jun 18, 2012 CSI Stealth 360-degree Orbital Atherectomy Device (OAD), Part Number 70056-11... CSI has initiated a recall on specific lot numbers of Stealth 360-degree Orbital Atherectomy devi... Class II Cardiovascular Systems, Inc.
Jun 18, 2012 Sarns Modular Perfusion System 9000, 115V with color screen. The Sarns Per... Terumo Cardiovascular Systems has received several reports of malfunctions of the Air Bubble Dete... Class II Terumo Cardiovascular Systems Corporation
Jun 16, 2012 Custom surgical kits and trays: GEO-MED TOTAL KNEE PACK PGYBK, REF 89-6664.0... Surgical kits and trays contain Stryker Hytrel Togas which were recalled because the clear tape, ... Class II DeRoyal Industries Inc
Jun 15, 2012 Hitachi Echelon MRI System/Oasis MRI, Software. These are software controlled... Hitachi discovered a software error with a feature called Multi-Planar Reconstruction (MPR). MPR... Class II Hitachi Medical Systems America Inc
Jun 15, 2012 Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device tha... Multiple issues were identified with the GE Centricity PACS-IW system that could pose a safety ri... Class II Ge Healthcare It
Jun 15, 2012 AngioDynamics Angiographic catheter --- Soft-Vu (JB-1) Non-braided. --- Size:... AngioDynamics is recalling one lot of Soft-Vu Angiographic catheters because one of the catheter ... Class II Angiodynamics Worldwide Headquarters
Jun 15, 2012 STA Satellite Automated Multi-Parameter Analyzer This system is a fully au... Following a single customer complaint that incorrect INR values were occasionally printed for PT ... Class II Diagnostica Stago, Inc.
Jun 15, 2012 Equinoxe Reverse Shoulder Fracture Adapter Tray Screw Intended for Primary... Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinox... Class II Exactech, Inc.
Jun 15, 2012 Equinoxe Reverse Compression Screw Intended for Primary and Reverse Total ... Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinox... Class II Exactech, Inc.
Jun 15, 2012 Equinoxe Anatomic Replicator Plate Intended for Primary and Reverse Total ... Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinox... Class II Exactech, Inc.
Jun 15, 2012 Equinoxe Reverse Glenosphere Locking Screw Intended for Primary and Revers... Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinox... Class II Exactech, Inc.
Jun 15, 2012 Alaris Pump Module Model 8100 (formerly Medley Pump Module) Subsequent Pro... The recall was initiated because Carefusion has identified a potential risk associated with the A... Class I CareFusion 303, Inc.
Jun 15, 2012 AEM Disposable Electrodes, Device, Electrosurgical, Cutting and Coagulation a... Encision is performing a field correction to their AEM Disposable Electrodes due to two consumer ... Class II Encision, Inc.
Jun 15, 2012 Equinoxe Fixed Angle Replicator Plate Intended for Primary and Reverse Tot... Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinox... Class II Exactech, Inc.
Jun 15, 2012 Octane-C Cervical, 6¿ Lordotic Intended for anterior cervical spine interver... Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinox... Class II Exactech, Inc.
Jun 14, 2012 OrthoPediatrics PediLoc Locking Plate System, 4.5mm Contour Locking Compressi... The device is a Left 8 hole plate but is incorrectly labeled and etched as a Right device. Class II OrthoPediatrics Corp
Jun 14, 2012 The 2.7mm Drilling Guide is a reusable instrument used in conjunction with a ... Integra' s quality system noted an adverse trend in complaints for breakage of the drilling guide... Class II Integra Life Sci.
Jun 14, 2012 Philips Xcelera Connect, Software R2.1 L 1 SP2, an interface engine for data... Xcelera Connect R2.1 L 1 SP2 , incomplete information arriving from unformatted reports interface Class II Philips Healthcare Inc.
Jun 13, 2012 seprafilm¿ Single Site ADHESION BARRIER Re-order Number: 6641-01 Product ... Sterility of product may be compromised due to packaging defect Class II Genzyme Corporation
Jun 13, 2012 seprafilm¿ Procedure Pack ADHESION BARRIER Re-order Number: 5086-02 Pro... Sterility of product may be compromised due to packaging defect Class II Genzyme 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.