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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

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
May 29, 2014 STOPCOCK EXT. SET W/ 3-WAY STOPCOCK WITH INJ. SITE AND SPINLOCK CONNECTOR, 22... Complaints were received that reported the stopcock of some Stopcock Extension Sets are assembled... Class II B. Braun Medical, Inc.
May 28, 2014 VTI BAYONET DOPPLER, 20MHz DOPPLER PROBE, SLIM, BX 4, REF 108660 The Doppl... Report of the product penetrating the sterile barrier; this could render the product unsterile. Class II Vascular Technology, Inc.
May 28, 2014 Gel-E Donut, Squishon 2 gel pillows Product Usage:: The products are inten... The gel-filled Gel-E Donut and Squishon product line has received a number of complaints about vi... Class I Childrens Medical Ventures
May 28, 2014 HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating... Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guid... Class I Nitinol Devices and Components, Inc.
May 28, 2014 HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating... Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guid... Class I Nitinol Devices and Components, Inc.
May 28, 2014 HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating... Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guid... Class I Nitinol Devices and Components, Inc.
May 28, 2014 HydroFinity Hydrophilic guidewire;Nitinol Guidewire with Hydrophilic Coating,... Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guid... Class I Nitinol Devices and Components, Inc.
May 28, 2014 Abacus 3.1, Pharmacy Calculator Product Usage: Provide pharmacy calculati... Baxter Corporation is initiating a field correction following an upgrade to ABACUS Software v3.1,... Class II Baxter Corporation Englewood
May 28, 2014 Siemens Linear Accelerators of type ARTISTE, ONCOR, and PRIMUS with Automatic... A safety risk exists with automatically sequenced treatment technique using the SIMTEC Auto Field... Class II Siemens Medical Solutions USA, Inc
May 28, 2014 HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating... Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guid... Class I Nitinol Devices and Components, Inc.
May 28, 2014 HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating... Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guid... Class I Nitinol Devices and Components, Inc.
May 28, 2014 HydroFinity Hydrophilic guidewire;Nitinol Guidewire with Hydrophilic Coating,... Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guid... Class I Nitinol Devices and Components, Inc.
May 28, 2014 07-150-12 MIZUHO, MINI, SLIM, STERILE, BOX OF 4, REF 138665 The Doppler pr... Report of the product penetrating the sterile barrier; this could render the product unsterile. Class II Vascular Technology, Inc.
May 28, 2014 HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating... Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guid... Class I Nitinol Devices and Components, Inc.
May 28, 2014 HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating... Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guid... Class I Nitinol Devices and Components, Inc.
May 28, 2014 07-150-10 MIZUHO, DOPPLER PROBE, SLIM, BX 4, REF 138660 The Doppler probe ... Report of the product penetrating the sterile barrier; this could render the product unsterile. Class II Vascular Technology, Inc.
May 28, 2014 HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating... Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guid... Class I Nitinol Devices and Components, Inc.
May 28, 2014 07-150-07 MIZUHO, MAL DISP DOPPLER PROBE BX 4, REF 138200 The Doppler prob... Report of the product penetrating the sterile barrier; this could render the product unsterile. Class II Vascular Technology, Inc.
May 28, 2014 HydroFinity Hydrophilic guidewire; 0.035 OD, Stiff Shaft, Straight Tip, 180... Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guid... Class I Nitinol Devices and Components, Inc.
May 28, 2014 Shape HF Cardiopulmonary System. Made up of Shape HF System Analyzer (PN 00... Shape Medical has initiated a correction due to a mandatory software upgrade for the Shape HF Car... Class II Shape Medical Systems, Inc
May 28, 2014 HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating... Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guid... Class I Nitinol Devices and Components, Inc.
May 27, 2014 Dimension¿ Integrated Chemistry Systems intended to measure a variety of anal... There is a misassembly issue with the photometer installed on Dimension¿ Integrated Chemistry Sy... Class III Siemens Healthcare Diagnostics, Inc.
May 27, 2014 FirmArray Blood Culture Identification (BCID) Panel, Model 2.0 The FilmArr... BioFire has identified an increased risk of false positive results when the FilmArray Blood Cultu... Class II BioFire Diagnostics, Inc.
May 27, 2014 Langston Dual Lumen Catheters, 6Fr, REF 5550 and 5540. The Vascular Solutions... The inner catheter of some Langston V2 Dual Lumen Catheters have separated from the device hub du... Class I Vascular Solutions, Inc.
May 23, 2014 Terumo TenderFlow Pediatric Venous Cannulae, 8, 10, 12, 14, 16, 18, 20, 22 & ... During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presen... Class II Terumo Cardiovascular Systems Corporation
May 23, 2014 RUSCH, LaserTube (Rubber), Laser Resistant Tracheal Tube, cuffed, Teleflex Me... Although the Natural Rubber Latex caution symbol is clearly displayed on the product label, the ... Class II Teleflex Medical
May 23, 2014 Sarns Soft-arc Aortic Cannula 8.0mm curved tip, suture flange, 3/8" flare ... During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presen... Class II Terumo Cardiovascular Systems Corporation
May 23, 2014 CSI Cardiovascular Systems, Inc., Diamondback 360 Peripheral Orbital Atherect... CSI has initiated a recall on the Diamondback 360 Peripheral Orbital Atherectomy Device because i... Class I Cardiovascular Systems, Inc.
May 23, 2014 Zimmer M/L Taper Reduced Neck Standard & Extended Offset, HIP JOINT PROSTHESI... Black residue observed in the sterile pouch of the M/L Taper and Kinectiv stems. Class II Zimmer, Inc.
May 23, 2014 Sarns Soft-Flow Aortic Cannulae 6.0mm, 7mm & 8mm angled and straight tip, sut... During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presen... Class II Terumo Cardiovascular Systems Corporation
May 23, 2014 Sarns Malleable Venous Return Cannulae 24, 28, 30, 32, 34, 36 & 40 Fr single ... During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presen... Class II Terumo Cardiovascular Systems Corporation
May 23, 2014 Zimmer M/L Taper Hip Stem Standard & Extended Offset, HIP JOINT PROSTHESIS, ... Black residue observed in the sterile pouch of the M/L Taper and Kinectiv stems. Class II Zimmer, Inc.
May 23, 2014 CPB Catheter Kit Product Usage: Venous Return Cannula is indicated for ve... During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presen... Class II Terumo Cardiovascular Systems Corporation
May 23, 2014 Sarns Soft-Flow Extended Aortic Cannulae 7.0mm & 8.0mm with or without luer &... During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presen... Class II Terumo Cardiovascular Systems Corporation
May 23, 2014 RAPIDPoint 500 Measurement Clinical Chemistry System RAPIDPoint 500 Measurem... RAPIDPoint 500 Measurement Cartridges may have an error code one or more electrolyte parameters ... Class II Siemens Healthcare Diagnostics Inc
May 23, 2014 Terumo Three-stage Venous Return Cannulae 28 Fr with 3/8" flare, 30 Fr with 3... During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presen... Class II Terumo Cardiovascular Systems Corporation
May 23, 2014 Sarns Venoatrial Cannulae 36/46 Fr with 1/2" flare or connector Product Us... During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presen... Class II Terumo Cardiovascular Systems Corporation
May 23, 2014 Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology, HIP JOINT PROSTHESI... Black residue observed in the sterile pouch of the M/L Taper and Kinectiv stems. Class II Zimmer, Inc.
May 23, 2014 MOSAIQ, an oncology information system used to manage workflows for treatment... When using CMA, if the user hovers the mouse pointer exactly above the direction dropdowns and th... Class II Elekta, Inc.
May 23, 2014 Sarns Flexible Aortic Arch Cannula 8.0mm with luer, 3/8" connector Product... During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presen... Class II Terumo Cardiovascular Systems Corporation
May 23, 2014 GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV an... Potential loss of airway gas measurement in the Compact Airway Gas Modules. Loosening of the ga... Class II GE Healthcare, LLC
May 23, 2014 Terumo Dual-stage Venous Return Cannulae 28/38, 29/37, 32/40, 34/46, 36/46 & ... During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presen... Class II Terumo Cardiovascular Systems Corporation
May 23, 2014 Sarns Two-stage Venous Return Cannulae 32/40 & 36/51 Fr with 1/2" & 3/8" flar... During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presen... Class II Terumo Cardiovascular Systems Corporation
May 23, 2014 Sarns Malleable Dual-stage Venous Return Cannulae 28/38, 32/40 & 34/46 Fr wit... During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presen... Class II Terumo Cardiovascular Systems Corporation
May 23, 2014 Sarns D4 Aortic Arch Cannulae 6.0mm, 7mm & 8mm angled and straight tip with o... During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presen... Class II Terumo Cardiovascular Systems Corporation
May 22, 2014 Lindemann Drill Short, 1.6mm Sterile Product Usage: The devices are inte... There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... Class II Stryker Instruments Div. of Stryker Corporation
May 22, 2014 Stryker 1.3mm Wire Pass Drill Sterile Product Usage: The devices are int... There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... Class II Stryker Instruments Div. of Stryker Corporation
May 22, 2014 GE OEC Brivo 865 plus, Mobile X-ray system laser aimer assemblies (part numbe... Laser aimer assemblies were shipped without certification of the overall assembly or submitting a... Class II GE OEC Medical Systems, Inc
May 22, 2014 Stryker 5.0mm Egg Bur Sterile Product Usage: The devices are intended to... There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... Class II Stryker Instruments Div. of Stryker Corporation
May 22, 2014 Stryker 5.0mm Barrel Bur Sterile There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... Class II Stryker Instruments Div. of Stryker 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.