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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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Browse Device Recalls

1,708 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,708 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 1,708 FDA device recalls.

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DateProductReasonClassFirm
Sep 26, 2017 6F Taiga Guiding Catheter Complaints regarding 6F Taiga guide catheter tip detachment and/or tip splitting. Class I Medtronic Inc
Sep 21, 2017 Medtronic Ascenda(R) Intrathecal Catheter, Models: (a) 8780, UDI: 006431692... There is a possibility that specific lots of catheters that have recently been distributed may be... Class III Medtronic Neuromodulation
Sep 13, 2017 Medtronic Aptus Heli-FX Thoracic EndoAnchor System Heli-FX Guide 42 mm, REF H... It was determined that the deflection length indicated on the Guide catheter handle does not matc... Class II Medtronic Vascular, Inc.
Sep 10, 2017 Medtronic MiniMed(TM) Quick-set(TM) (MMT-394, 394T, 399, 399T, 387, 387T, 398... Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin. Class II Medtronic Inc.
Sep 10, 2017 Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T... Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin. Class II Medtronic Inc.
Sep 10, 2017 Medtronic MiniMed(TM) Silhouette(TM) (MMT-377, 377T, 378, 378T, 384, 384T, 36... Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin. Class II Medtronic Inc.
Sep 10, 2017 Medtronic MiniMed(TM) Sure-T(TM) (MMT-862, 862T, 864, 864T, 866, 866T, 874, 8... Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin. Class II Medtronic Inc.
Sep 10, 2017 Medtronic MiniMed(TM) Pro-set(TM) (MMT-280, 281) Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin. Class II Medtronic Inc.
Aug 9, 2017 Medtronic Synchromed II Model 8637 supplied in 20mL and 40 mL reservoir size ... Medtronic implemented a final design change intended to address the motor stall due to corrosion ... Class II Medtronic Neuromodulation
Jul 27, 2017 VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visuala... The VCLAS 3mm, 10mm, and 15mm tip devices were not appropriately tested for saline leakage during... Class II Medtronic Navigation, Inc.
Jul 17, 2017 Covidien Vistec" X-Ray Detectable Sponges, 7317 Vistec" X-Ray Detectable Spon... Medtronic is voluntarily recalling two production lots of its Covidien Vistec" x-ray detectable s... Class II Covidien LP
Jul 14, 2017 MyCareLink Patient Monitors. It is intended for used with a compatible Med... Patients monitored on two (2) or more implanted Medtronic heart devices in the Medtronic CareLink... Class II Medtronic Inc., Cardiac Rhythm and Heart Failure
Jul 14, 2017 MyCareLink Smart Patient Monitors. It is intended for use with a compatibl... Patients monitored on two (2) or more implanted Medtronic heart devices in the Medtronic CareLink... Class II Medtronic Inc., Cardiac Rhythm and Heart Failure
Jul 13, 2017 Euphora Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Translumin... Stylette removal difficulties on the Euphora and Solarice products. Class II Medtronic Vascular Galway DBA Medtronic Ireland
Jul 13, 2017 Solarice Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Translumi... Stylette removal difficulties on the Euphora and Solarice products. Class II Medtronic Vascular Galway DBA Medtronic Ireland
Jun 29, 2017 SORIN GROUP, SMART PERFUSION PACK, SMART VENOUS VACUUM, REF 084118102, STERIL... Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged ... Class II Sorin Group USA, Inc.
Jun 29, 2017 SORIN GROUP, SMART PERFUSION PACK, NEONATE/PEDIATRIC PACK, REF 627127702, STE... Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged ... Class II Sorin Group USA, Inc.
Jun 29, 2017 STERILE SAMPLE SORIN GROUP, SMART PERFUSION PACK, NEONATE/PEDIATRIC PACK, REF... Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged ... Class II Sorin Group USA, Inc.
Jun 29, 2017 SORIN GROUP, SMART PERFUSION PACK, SMART 3/16" PEDS PACK, REF 627263601, STER... Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged ... Class II Sorin Group USA, Inc.
Jun 29, 2017 SORIN GROUP, SMART PERFUSION PACK, LONG PACK, REF 088512600, STERILE EO, Rx O... Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged ... Class II Sorin Group USA, Inc.
Jun 29, 2017 Medtronic Straight Suction 9733449 EM ENT, reusable, Rx. The firm name on th... The instruments are not able to pass instrument verification which is performed prior to the use ... Class II Medtronic Navigation, Inc.
Jun 29, 2017 NON-STERILE SAMPLE, SORIN GROUP, SMART CARDIOPLEGIA, CARDIOPLEGIA PACK, REF 6... Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged ... Class II Sorin Group USA, Inc.
Jun 29, 2017 Medtronic Curved Suction 70 9733450 EM ENT, reusable, Rx. The firm name on t... The instruments are not able to pass instrument verification which is performed prior to the use ... Class II Medtronic Navigation, Inc.
Jun 29, 2017 Spine Referencing Instrumentation, Spinous Process Clamp, Short When used wi... Potential for Spinal Clamps to be damaged when opened beyond intended limits, either no opening o... Class II Medtronic Navigation, Inc.
Jun 29, 2017 NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS, REF 04404... Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged ... Class II Sorin Group USA, Inc.
Jun 29, 2017 Medtronic Instrument Kit 9733908 Fusion ENT, reusable, RX. This kit includes... The instruments are not able to pass instrument verification which is performed prior to the use ... Class II Medtronic Navigation, Inc.
Jun 29, 2017 SORIN GROUP, SMART PERFUSION PACK, PUMP AND TABLE PACK, REF 627374101, STERIL... Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged ... Class II Sorin Group USA, Inc.
Jun 29, 2017 Spine Referencing Instrumentation, Spinous Process Clamp, Tall When used wit... Potential for Spinal Clamps to be damaged when opened beyond intended limits, either no opening o... Class II Medtronic Navigation, Inc.
Jun 29, 2017 Medtronic Set Supplemental INS AxiEM ENT, Ref. 9734378, reusable, RX. This k... The instruments are not able to pass instrument verification which is performed prior to the use ... Class II Medtronic Navigation, Inc.
Jun 29, 2017 SORIN GROUP, SMART PERFUSION PACK, TOTAL VISION SYSTEM-SMA, REF 084510101, ST... Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged ... Class II Sorin Group USA, Inc.
Jun 29, 2017 Spine Referencing Instrumentation, Double Spinous Process Clamp, Tall When u... Potential for Spinal Clamps to be damaged when opened beyond intended limits, either no opening o... Class II Medtronic Navigation, Inc.
Jun 29, 2017 SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8S, REF 044036101, STERILE EO, Rx ... Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged ... Class II Sorin Group USA, Inc.
Jun 29, 2017 SORIN GROUP, SMART PERFUSION PACK, SMA PRIMO2X OPTI PACK, REF 088512900, STER... Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged ... Class II Sorin Group USA, Inc.
Jun 29, 2017 SORIN GROUP, SMART PERFUSION PACK, INSPIRE 6FS, REF 044008204, STERILE EO, Rx... Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged ... Class II Sorin Group USA, Inc.
Jun 29, 2017 Medtronic Curved Suction 90 9733451 EM ENT, reusable, Rx. The firm name on ... The instruments are not able to pass instrument verification which is performed prior to the use ... Class II Medtronic Navigation, Inc.
Jun 29, 2017 SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS S5 PACK W/CARDIOPLEGIA-3D, (a)... Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged ... Class II Sorin Group USA, Inc.
Jun 29, 2017 Spine Referencing Instrumentation, Double Spinous Process Clamp, Short When ... Potential for Spinal Clamps to be damaged when opened beyond intended limits, either no opening o... Class II Medtronic Navigation, Inc.
Jun 29, 2017 Medtronic Suction 9734308 Small AxiEM ENT, reusable, Rx. The firm name on th... The instruments are not able to pass instrument verification which is performed prior to the use ... Class II Medtronic Navigation, Inc.
Jun 29, 2017 NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, REF 627376401, 1 EA, N... Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged ... Class II Sorin Group USA, Inc.
Jun 29, 2017 Spine Referencing Instrumentation, Set, Contains Spinous Process Clamps, Shor... Potential for Spinal Clamps to be damaged when opened beyond intended limits, either no opening o... Class II Medtronic Navigation, Inc.
Jun 29, 2017 Medtronic Instrument Set EM ENT, Ref. #9733452 and #9733452-G02, reusable, R... The instruments are not able to pass instrument verification which is performed prior to the use ... Class II Medtronic Navigation, Inc.
Jun 29, 2017 Medtronic ENT Prgm 9734636 Add Fusion Nav AxiEM, reusable, Rx. This kit incl... The instruments are not able to pass instrument verification which is performed prior to the use ... Class II Medtronic Navigation, Inc.
Jun 29, 2017 SORIN GROUP, SMART PERFUSION PACK, SMART CIRCULATORY ASSIST PACK, REF 6272550... Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged ... Class II Sorin Group USA, Inc.
Jun 29, 2017 SORIN GROUP, SMART PERFUSION PACK, SMART 1/4" PEDS PACK, REF 627262502, STERI... Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged ... Class II Sorin Group USA, Inc.
Jun 22, 2017 DLP Extension Line Adapters 20 in length Used to extend cardioplegia line du... Identification of small pinholes in a single packaging configuration of sterile pouches. A total... Class II Medtronic Perfusion Systems
Jun 22, 2017 DLP Pressure Monitoring Extension Line Adapters Extends the pressure line in... Identification of small pinholes in a single packaging configuration of sterile pouches. A total... Class II Medtronic Perfusion Systems
Jun 22, 2017 DLP Cardioplegia Adapter with Pressure Port Provides access for a pressure m... Identification of small pinholes in a single packaging configuration of sterile pouches. A total... Class II Medtronic Perfusion Systems
Jun 22, 2017 DLP Antegrade/Retrograde Adapter Method for perfusion of cardioplegia altern... Identification of small pinholes in a single packaging configuration of sterile pouches. A total... Class II Medtronic Perfusion Systems
Jun 22, 2017 DLP Pressure Disposable Pressure Display Sets Extends the pressure line in o... Identification of small pinholes in a single packaging configuration of sterile pouches. A total... Class II Medtronic Perfusion Systems
Jun 7, 2017 Medtronic Visualase(R) Cooled Laser Applicator System (VCLAS) 15MM TIP, REF 9... Medtronic has become aware that the VCLAS 15MM TIP cap, also referred to as Tuohy Borst Adapter (... Class II Medtronic Navigation, 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.