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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

1,730 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,730 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 1,730 FDA device recalls.

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DateProductReasonClassFirm
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.
May 17, 2017 KYPHON(R) Directional Bone Filler Device, Size: 3, REF F04C, Rx Only, STERILE R. The directional arrow at the proximal end of the instrument may not correctly align with the cut... Class II Medtronic Sofamor Danek USA Inc
May 10, 2017 Install CD, Spine tools, Plus and S7, Version 25. Model Number 9731958. Software issue related to the StealthStation S7 system and the Synergy Spine application Version ... Class II Medtronic Navigation, Inc.
May 8, 2017 MiniMed 640G Insulin Infusion Pump, Catalog No. MMT-1511, MMT-1711, MMT-1512,... Medtronic MiniMed is recalling the MiniMed 600 series insulin pump because it may become temporar... Class II Medtronic Inc.
May 8, 2017 MiniMed 630G Insulin Infusion Pump, Catalog No. MMT-1715, MMT-1755. Medtronic MiniMed is recalling the MiniMed 600 series insulin pump because it may become temporar... Class II Medtronic Inc.
May 8, 2017 MiniMed 670G Insulin Infusion Pump, Catalog No. MMT-1580, MMT-1780, MMT-1782,... Medtronic MiniMed is recalling the MiniMed 600 series insulin pump because it may become temporar... Class II Medtronic Inc.
May 8, 2017 MiniMed 620G Insulin Infusion Pump, Catalog No. MMT-1510, MMT-1710, MMT-1550,... Medtronic MiniMed is recalling the MiniMed 600 series insulin pump because it may become temporar... Class II Medtronic Inc.
May 3, 2017 Sutures. POLYSORB: POLSORB 0 18 U/D PRECUT 126R, Item Number: L4; POLSORB 0 ... Potential for an incomplete seal on the inner package, which may result in premature degradation ... Class II Medtronic
May 3, 2017 Sutures. MAXON: MAXON 4/0 5X18" GREEN CV-24 D-TACH; Item Number: 8886621933;... Potential for an incomplete seal on the inner package, which may result in premature degradation ... Class II Medtronic
May 3, 2017 USPACK-SUTURE KIT; Item Number: US1672 Potential for an incomplete seal on the inner package, which may result in premature degradation ... Class II Medtronic
May 3, 2017 Best Practice Kit, Item Numbers: 00Z2064, 00Z2150, 00Z2190, 00Z2192, 00Z2211,... Potential for an incomplete seal on the inner package, which may result in premature degradation ... Class II Medtronic
May 3, 2017 Sutures. ENDO STITCH: ENDO STITCH POLYSORB 0 48" U/D DLU SU, Item Number: 17... Potential for an incomplete seal on the inner package, which may result in premature degradation ... Class II Medtronic
May 3, 2017 Sutures. BIOSYN: BIOSYN 4/0 18" VIOLET CV-25 DT, Item Number: GMJ34M Potential for an incomplete seal on the inner package, which may result in premature degradation ... Class II Medtronic
May 3, 2017 CUSTOM SUTURE PACK; Item Number: US1540 and US1614 Potential for an incomplete seal on the inner package, which may result in premature degradation ... Class II Medtronic
May 3, 2017 SCHRITTMACHER ANGIO X3; Item Number: 4045255423347 Potential for an incomplete seal on the inner package, which may result in premature degradation ... Class II Medtronic
Apr 13, 2017 Medtronic PAK NEEDLE BEVELED AND TROCAR TIPS, REF 8670009, QTY 1 EA, STERILE ... Product packaging may incorrectly include two bevel-tipped needles or two trocar-tipped needles i... Class II Medtronic Sofamor Danek USA Inc
Apr 12, 2017 Amplia MRI Quad CRT-0 SureScan Claria MRI Quad CRT-D SureScan Compia MRI Qu... An unexpected transient mode switch behavior was detected by Medtronic during systems testing tha... Class II Medtronic Inc., Cardiac Rhythm and Heart Failure
Mar 30, 2017 Newport Medical HT70 and HT70- Plus Ventilators, Rx Only Product Usage: T... Medtronic is issuing a voluntary field corrective action for all its Newport" HT70 and Newport" H... Class I Newport Medical Instruments Inc
Mar 17, 2017 DBS Lead Depth Stop contained in Medtronic Deep Brain Stimulation (DBS) lead ... Medtronic received reports that the DBS depth stop did not adequately secure to the lead, which c... Class II Medtronic Neuromodulation
Mar 16, 2017 Ortho Basic Pack, part number AMS6459 Product packaged in a convenient ma... AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... Class II Windstone Medical Packaging, Inc.
Mar 16, 2017 Plastic Pack, part numbers AMS1028, AMS1028(A, and WAL1189. Product packaged... AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... Class II Windstone Medical Packaging, Inc.
Mar 16, 2017 Eye Pack, part numbers WAL1085(B and WAL1085(C\ Product packaged in a conven... AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... Class II Windstone Medical Packaging, Inc.
Mar 16, 2017 Custom Tray, part numbers PSS1111 and PSS1111(A. Product packaged in a con... AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... Class II Windstone Medical Packaging, Inc.
Mar 16, 2017 Minor Operation Kit, part number AMS1530 Product packaged in a convenient ma... AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... Class II Windstone Medical Packaging, Inc.
Mar 16, 2017 Eye Cataract Pack, part numbers AMS1359 and AMS1359-1 Product packaged in a ... AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... Class II Windstone Medical Packaging, Inc.
Mar 16, 2017 Cataract Kit, part numbers CAT1467AM and CAT1538(B. Product packaged in a ... AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... Class II Windstone Medical Packaging, Inc.
Mar 16, 2017 Cataract Kit - Dr. Slingsby, part number CMP1017(B. Product packaged in a co... AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... Class II Windstone Medical Packaging, Inc.
Mar 16, 2017 ENT Pack, part number AMS2727 Product packaged in a convenient manner for us... AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... Class II Windstone Medical Packaging, Inc.
Mar 16, 2017 Lasik Tray, part number DDS1045-2 Product packaged in a convenient manner fo... AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... Class II Windstone Medical Packaging, 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.