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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

2,729 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,729 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 2,729 FDA device recalls in 2014.

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DateProductReasonClassFirm
Feb 5, 2014 Fisherbrand Sterile Swabs, Calcium Alginate Fiber Tipped Aluminum Applicator ... A customer reported the presence of an organism in a lot of Calcium Alginate Fiber Tipped Wood Ap... Class II Fisher Scientific Co
Feb 5, 2014 Product Brand Name(s): Alere Triage¿ TOX+MTD Drug Screen, Catalog Number 9440... Alere San Diego, Inc. is initiating a recall of the Alere Triage¿ TOX Drug Screen, Catalog Number... Class II Alere San Diego, Inc.
Feb 4, 2014 Optiflux F180NRe High Flux Dialyzers; Product Number: 0500318E. Single Use... Dialysate Port Leak During Priming of the Dialyzers Class II Fresenius Medical Care Holdings, Inc.
Feb 4, 2014 Optiflux F200A High Flux Dialyzers; Product Number: 0500320A. Single Use a... Dialysate Port Leak During Priming of the Dialyzers Class II Fresenius Medical Care Holdings, Inc.
Feb 4, 2014 Optiflux F160NR High Flux Dialyzers; Product Number: 0500316N. Single Use ... Dialysate Port Leak During Priming of the Dialyzers Class II Fresenius Medical Care Holdings, Inc.
Feb 4, 2014 Boston Scientific, Coyote" MONORAIL" PTA Balloon Dilatation Catheter, UPN # H... Boston Scientific is initiating this Recall Removal of one lot of the Coyote" OVER-THE-WIRE PTA B... Class II Boston Scientific Corporation
Feb 4, 2014 Optiflux F180NR High Flux Dialyzers; Product Number: 0500318N. Single Use ... Dialysate Port Leak During Priming of the Dialyzers Class II Fresenius Medical Care Holdings, Inc.
Feb 4, 2014 Boston Scientific, 2.5mm Coyote" OVER-THE-WIRE PTA Balloon Dilation Catheter,... Boston Scientific is initiating this Recall Removal of one lot of the Coyote" OVER-THE-WIRE PTA B... Class II Boston Scientific Corporation
Feb 4, 2014 Optiflux F18Nre Flux Dialyzers; Product Number: 0500308E. Single Use acute... Dialysate Port Leak During Priming of the Dialyzers Class II Fresenius Medical Care Holdings, Inc.
Feb 4, 2014 Simplexa Flu AlB & RSV Direct Assay Kits, intended for use as an aid in the d... Focus Diagnostics initiated the recall of the certain Simplexa Flu AlB & RSV Direct assay kits d... Class II Focus Diagnostics Inc
Feb 4, 2014 Philips HeartStart MRx Monitor/Defibrillator used Model numbers: M3535A, M... HeartStart MRx Defibrillator Monitor therapy connection could experience accelerated wear causing... Class II Philips Medical Systems, Inc.
Feb 4, 2014 Optiflux B200 Flux Dialyzers; Product Number: 0500325E. Single Use acute o... Dialysate Port Leak During Priming of the Dialyzers Class II Fresenius Medical Care Holdings, Inc.
Feb 4, 2014 Optiflux F160NRe High Flux Dialyzers; Product Number: 0500316E. Single Use... Dialysate Port Leak During Priming of the Dialyzers Class II Fresenius Medical Care Holdings, Inc.
Feb 4, 2014 Optiflux F200NRe High Flux Dialyzers; Product Number: 0500320E. Single Use... Dialysate Port Leak During Priming of the Dialyzers Class II Fresenius Medical Care Holdings, Inc.
Feb 4, 2014 Optiflux F200NR High Flux Dialyzers; Product Number: 0500320N. Single Use ... Dialysate Port Leak During Priming of the Dialyzers Class II Fresenius Medical Care Holdings, Inc.
Feb 3, 2014 Mega-Gen His Personal Lubricant, 8 fl. oz., Meta Labs, UPC Code 80708-3; Mega... Firm is not registered as a drug manufacturer. Class II Altasource LLC dba Meta Labs LLC
Feb 3, 2014 IMMULITE 2000; IMMULITE 2000XPi; VersaCell The IMMULITE 2000 systems are c... There is a potential for incorrect results to be reported from processing of a sample tube. Class II Siemens Medical Solutions Diagnostics
Feb 3, 2014 The GemStar Power Supply is an accessory for the GemStar Infusion Pump. It is... The GemStar Infusion pump may not receive direct current (DC) power from the power supply. In one... Class I Hospira Inc.
Feb 3, 2014 The GemStar Power Supply is an accessory for the GemStar Infusion Pump. It is... The GemStar Infusion pump may not receive direct current (DC) power from the power supply. In one... Class I Hospira Inc.
Feb 3, 2014 Amo-O Herbal Stimulator, 2 fl. oz. Manufactured by Meta Labs, Alpharetta, GA ... Firm is not registered as a drug manufacturer. Class II Altasource LLC dba Meta Labs LLC
Feb 3, 2014 Nice-En-Smooth Berry Burst, 4 oz., Manufactured by Meta Labs LLC, UPC 80604-8... Firm is not registered as a drug manufacturer. Class II Altasource LLC dba Meta Labs LLC
Feb 3, 2014 Citation TMZF HA 132 degrees Neck Angle, V40 Hip Stem - Right Size #3: catalo... Stryker received a report from the field indicating that a citation TMZF HA 132 degrees neck angl... Class II Stryker Howmedica Osteonics Corp.
Feb 3, 2014 Hot Ice, 1 fl. oz., Meta Labs LLC, UPC 80705-2 Product Usage: A topical g... Firm is not registered as a drug manufacturer. Class II Altasource LLC dba Meta Labs LLC
Feb 3, 2014 Treatment packs used on the VisuMax Laser Keratome. Size M Manufactured b... Carl Zeiss Treatment pack, lot number M 130010, size M, may actually contain size S. Class II Carl Zeiss Meditec AG
Feb 3, 2014 OneTray Sealed Sterilization Containers Product Usage: A rigid sterilizat... The wrong sterilization time was on the label. The label lists Steam Gravity 10 - 34 minutes at ... Class II Innovative Sterlization Technologies LLC
Jan 31, 2014 MAQUET PLEGIOX Cardioplegia Heat Exchanger The PLEGIOX Cardioplegia Heat E... The MAQUET post-marketing vigilance program has identified a discrepancy that the desired cardio... Class II Maquet Cardiovascular Us Sales, Llc
Jan 31, 2014 GemStar infusion pump, List numbers 13000 and 13100, GemStar Infusion Pump (... The connection between the beeper subassembly and the pump may fail. The GemStar infusion pump wi... Class II Hospira Inc.
Jan 31, 2014 Greatbatch Medical, Offset Cup Impactor. Part Numbers: P9485, T10243, T1028... Greatbatch Medical has initiated a global Field Corrective Action for the Standard Offset Cup Imp... Class I Greatbatch Medical
Jan 31, 2014 Otto Bock Aerial and Aerial Active Wheelchair Cushions. Material numbers: S... Otto Bock is recalling all Aerial and Aerial Active Wheelchair Cushions from specific material nu... Class II Bock,Otto,Orthopedic Ind,Inc
Jan 30, 2014 Medtronic Select CAP Arterial Cannulae. Vented, models 78818 (18 Fr.), 7882... Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product famili... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Jan 30, 2014 PRE1055US: Prevena Dressing, 5 Pack (US-ONLY) Product Usage: The Prevena ... Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is... Class II KCI USA, INC.
Jan 30, 2014 PRE2001US: Prevena Incision Management Customizable System Box (US-ONLY) P... Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is... Class II KCI USA, INC.
Jan 30, 2014 PRE1001: Prevena Peel and Place System Kit Product Usage: The Prevena In... Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is... Class II KCI USA, INC.
Jan 30, 2014 Medtronic Select 3D Arterial Cannulae. Vented, model 78622 (22 Fr.). Non-V... Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product famili... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Jan 30, 2014 Medtronic Intersept Custom Tubing Pack which contain Select 3D or Select CAP ... Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product famili... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Jan 30, 2014 PRE2055: Prevena Customizable Dressing 5-Pack Product Usage: The Prevena ... Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is... Class II KCI USA, INC.
Jan 30, 2014 PRE2001: Prevena Incision Management Customizable System Box Product Usage... Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is... Class II KCI USA, INC.
Jan 30, 2014 PRE2055US: Prevena Customizable Dressing 5-Pack (US-ONLY) Product Usage: ... Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is... Class II KCI USA, INC.
Jan 30, 2014 Synthes CMF Battery Powered Driver, Part no. 305.840. Used to place screws i... The CMF Battery Powered Driver graphic case contains outlines of the Battery Powered Driver, tap... Class II Synthes, Inc.
Jan 30, 2014 Medtronic Select 3D Arterial Cannulae. Vented, model 78624 (24 Fr.). Non-V... Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product famili... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Jan 30, 2014 Medtronic Select 3D Arterial Cannulae. Vented, models 78618 (18 Fr.) and 78... Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product famili... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Jan 30, 2014 Medtronic Select CAP Arterial Cannulae. Non-Vented, Carmeda Coated, model CB... Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product famili... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Jan 30, 2014 PRE1055: Prevena Dressing, 5 Pack Product Usage: The Prevena Incision Man... Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is... Class II KCI USA, INC.
Jan 30, 2014 PRE1001US: Prevena Peel and Place System Kit (US-ONLY) Product Usage: Th... Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is... Class II KCI USA, INC.
Jan 29, 2014 SCC SA HIS version 4.0.7.0 when used with SoftMic version 4.0.7.0. SoftMi... When an isolate is resulted without a SNOMED code, isolate information in the downstream system m... Class II SCC Soft Computer
Jan 29, 2014 VITROS Chemistry Products CDM PROM (Calibration Data Module) No. 0168, Catalo... Customers were unable to calibrate, or use previously calibrated, VITROS DT CRSC slides (REF/Prod... Class II Ortho-Clinical Diagnostics
Jan 29, 2014 Gelzone Shoulder Sleeve, Catalog Number SLV634, Lot Number 852766. Product... Implantech initiated the voluntary recall of Gelzone Shoulder Sleever, SLV-634, Lot Number 852766... Class II Implantech Associates Inc
Jan 28, 2014 Accessory shorts for the AlterG Anti-Gravity treadmill. Use with the Alter... Unapproved material used by vendor in subset of shorts causing them to stretch more than usual an... Class II AlterG, Incorporated
Jan 28, 2014 AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002, diopte... Certain Silicone TECNIS IOLs may be labeled with the incorrect diopter power. Class II AMO Puerto Rico Manufacturing, Inc.
Jan 27, 2014 CSI, Diamondback 360 Coronary Orbital Atherectomy System, Part Number 70058-0... Cardio vascular Systems Inc. has initiated a recall to request the immediate removal and return o... Class III Cardiovascular Systems, 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.