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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

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 16, 2013 NC Sprinter; Rapid Exchange Balloon Dilatation Catheter; Sterile; 2.25 mm; M... Compliance chart included in lot 207002011 of the NC Sprinter RX 2.25 x 12 mm products lists the ... Class II Medtronic Vascular, Inc.
Aug 23, 2013 Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The e... One lot of the product was assembled using the Cam Head version of the same prosthesis instead of... Class II Medtronic Xomed, Inc.
Aug 12, 2013 T8 REMOVAL HEAD, REF 8910641, QTY: 1 EA, Product Usage: The non-sterile ... One lot of the T8 Removal Head had incorrect hardness specification, which could result in the T8... Class II Medtronic Sofamor Danek USA Inc
Jul 25, 2013 Medtronic O-arm Imaging System Mobile X-ray system. Model No. BI-700-00027 a... Review of on-system electronic product labeling and Instructions for comply with applicable Use i... Class II Medtronic Navigation, Inc.
Jul 17, 2013 Medtronic Custom Perfusion System with Trillium BioSurface (a polymer contain... Medtronic was notified that Edwards Lifesciences has initiated a product recall for the Rigid Suc... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Jul 17, 2013 Medtronic Custom Perfusion System. Model Numbers: 1D80R8, 1E34R1, 1F75R1, 1... Medtronic was notified that Edwards Lifesciences has initiated a product recall for the Rigid Suc... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Jul 17, 2013 Medtronic Custom Perfusion System with Carmeda BioActive Surface. Model Numb... Medtronic was notified that Edwards Lifesciences has initiated a product recall for the Rigid Suc... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Jul 15, 2013 StealthStation S7 Framelink Software version 5.4. Aid for locating anatom... Medtronic Navigation, Inc. has initiated a field correction to their Framelink software version 5... Class II Medtronic Navigation, Inc.
Jul 9, 2013 Tray Surgical, ENT (various instrument trays) Used for stot age and transp... The firm will recall and replace the identified instrument trays in the field, with trays that ha... Class II Medtronic Xomed, Inc.
Jul 8, 2013 Medtronic Mullins Transseptal Adult 7F, REF 008551. Intended for the intr... Medtronic identified a specific labeling issue for specific lots of Mullins Transseptal Catheter ... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Jul 3, 2013 Medtronic MiniMed Paradigm Reservoirs, Model No: MMT-326A (1.8mL) and MMT-332... Medtronic is recalling certain lots of Medtronic MiniMed Paradigm Reservoirs MMT-326A (1.8mL) and... Class II Medtronic MiniMed
Jun 28, 2013 Medtronic Preimplantation Test Kit, Catalog No. 21047. The kit is indicated f... Medtronic Neurosurgery is recalling the Medtronic Preimplantation Test Kit because the outer cart... Class II Medtronic Neurosurgery
Jun 14, 2013 Medtronic Affinity Pediatric Arterial Filter, model number S4014, sterilized ... Medtronic is recalling 148 Affinity Pediatric Arterial Filters from 2 manufacturing lots because ... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Jun 12, 2013 Medtronic, Launcher Guiding Catheter, Model # LA8EBU45SH, Lot # 0006722866, ... Medtronic has identified a labeling issue for 24 units of the Launcher coronary Guide Catheter. ... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Jun 7, 2013 Medtronic, Consulta¿ CRT-P, Model C4TR01, C3TR01 (not approved for US), and... Medtronic recently identified an issue with a subset of Consulta¿ CRT-P and Syncra¿ CRT-P devices... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Jun 7, 2013 Medtronic MiniMed Paradigm Insulin Infusion Sets The Paradigm infusion set... Medtronic is recalling the Medtronic MiniMed Paradigm Medtronic is recalling the Medtronic MiniMe... Class I Medtronic MiniMed
Jun 3, 2013 Medtronic SynchroMed EL Programmable pumps, Models 8626, 8626L, 8627, 8627L, ... Medtronic Neuromodulation is providing Healthcare Providers with safety information and patient m... Class I Medtronic Neuromodulation
Jun 3, 2013 Medtronic INDURA 1P Intrathecal Catheter, model 8709SC. Contents: 81.4-cm c... The Sutureless Connector (SC) Intrathecal Catheter connector has been redesigned to reduce the po... Class I Medtronic Neuromodulation
Jun 3, 2013 Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 2... Medtronic is providing Healthcare Professionals with important safety information and patient man... Class I Medtronic Neuromodulation
Jun 3, 2013 Medtronic SynchroMed EL Programmable pumps, Models 8626, 8626L, 8627, 8627L, ... Medtronic is providing Healthcare Professionals with important safety information and patient man... Class I Medtronic Neuromodulation
Jun 3, 2013 Medtronic Intrathecal Catheter Pump Segment Revision Kit, model 8596SC. Cont... The Sutureless Connector (SC) Intrathecal Catheter connector has been redesigned to reduce the po... Class I Medtronic Neuromodulation
Jun 3, 2013 Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 2... Medtronic Neuromodulation is providing Healthcare Providers with safety information and patient m... Class I Medtronic Neuromodulation
Jun 3, 2013 Medtronic Sutureless Pump Connector Revision Kit, model 8578. Contents: cat... The Sutureless Connector (SC) Intrathecal Catheter connector has been redesigned to reduce the po... Class I Medtronic Neuromodulation
Jun 3, 2013 Medtronic Intrathecal Catheter, model 8731SC. Contents: 38.1-cm spinal segm... The Sutureless Connector (SC) Intrathecal Catheter connector has been redesigned to reduce the po... Class I Medtronic Neuromodulation
May 28, 2013 INFUSE(R) Bone Graft,LARGE II KIT, REF 7510800, Medtronic Sofamore Danek USA,... Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resu... Class II Medtronic Sofamor Danek USA Inc
May 28, 2013 INFUSE(R) Bone Graft, MEDIUM KIT, REF 7510400, Medtronic Sofamore Danek USA, ... Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resu... Class II Medtronic Sofamor Danek USA Inc
May 28, 2013 INFUSE(R) Bone Graft, MEDIUM KIT, REF 7510400AUS, Medtronic Sofamore Danek US... Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resu... Class II Medtronic Sofamor Danek USA Inc
May 28, 2013 INFUSE(R) Bone Graft, LARGE KIT, REF 7510600, Medtronic Sofamore Danek USA, I... Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resu... Class II Medtronic Sofamor Danek USA Inc
May 28, 2013 INFUSE(R) Bone Graft, SMALL KIT, REF 7510200AUS, Medtronic Sofamore Danek USA... Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resu... Class II Medtronic Sofamor Danek USA Inc
May 28, 2013 INFUSE(R) Bone Graft, LARGE II KIT, REF 7510800AUS, Medtronic Sofamore Danek ... Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resu... Class II Medtronic Sofamor Danek USA Inc
May 28, 2013 INFUSE(R) Bone Graft, SMALL KIT, REF 7510200, Medtronic Sofamore Danek USA, I... Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resu... Class II Medtronic Sofamor Danek USA Inc
May 3, 2013 PadPro(R) Adult Radiotransparent Multifunction Electrodes, REF/Catalog No. 20... ConMed was notified by the contract manufacturer that their wire/connector supplier reported dama... Class II ConMed Corporation
May 3, 2013 - ACCU-PASS Suture Shuttle, 70 Degree, Upbend, (Orange) Ref. 72200419 Lot 122... The seal which maintains a sterile barrier for reprocessed medical devices became compromised to ... Class II Surgical Instrument Service And Savings, Inc.
Apr 30, 2013 adult defibrillation, cardioversion, pacing, monitoring Disposable Electrodes... TZ Medical Inc is recalling its P-211-M1 and P-214-M1 Medtronic / Physio Control Compatible trans... Class II TZ Medical Inc.
Mar 22, 2013 Medtronic MiniMed Paradigm Insulin Infusion Pumps Model Numbers: MMT-511, ... Medtronic is recalling the Medtronic Paradigm Insulin Pump because the pump's drive support cap m... Class II Medtronic MiniMed
Mar 13, 2013 Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewire, Models ARCSJ200W... Medtronic has identified an issue involving specific lot numbers of the Medtronic Archer 0.035 in... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Mar 13, 2013 Medtronic Archer Super Stiff Guidewire 0.035 inch (0.89mm), Model ARCSJ200W. ... Medtronic has identified an issue with a specific lot of the Archer 0.035 inch (0.89mm) Super Sti... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Mar 4, 2013 REF 8229705 x1 NIM TriVantage EMG Endotracheal Tube 5.0 mm I.D. x 6.5 mm O.D.... In March 2013, Medtronic issued a recall of the NIM TriVantage EMG Endotracheal Tube due to cuff ... Class I Medtronic Xomed, Inc.
Feb 27, 2013 Medtronic Prostiva RF Therapy Generator. The Prostiva RF system is indicat... Medtronic has found through device testing that if the optional footswitch is not connected to th... Class II Medtronic Neuromodulation
Feb 19, 2013 Medtronic DPL Single Stage Venous Cannula with Metal Tip, used in cardiopul... Potential for uncharacteristically rough metal edges to occur along the inner diameter of the met... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Feb 8, 2013 Medtronic DBS Lead Kit for Deep Brain Stimulation, models 3387, 3387S, 3389, ... There is a potential for lead damage due to the use of the lead cap provided in DBS and Dystonia ... Class I Medtronic Neuromodulation
Feb 8, 2013 Medtronic DBS Therapy for Dystonia Kit, models 3317, 3319, 3337 and 3339. S... There is a potential for lead damage due to the use of the lead cap provided in DBS and Dystonia ... Class I Medtronic Neuromodulation
Jan 31, 2013 Medtronic O-arm Imaging System Product Usage: image-intensified fluorosco... Potential failure of the braking system that controls the O-arm Imaging System gantry movement in... Class II Medtronic Navigation, Inc.
Dec 3, 2012 Medtronic, DBS Extension Kit for Deep Brain Stimulation, Catalog # 7482, 3708... Medtronic has identified 140 Restore DBS Extension Kits (model numbers 7482, 37085, and 37086), w... Class II Medtronic Neuromodulation
Nov 19, 2012 Medtronic Intersept Custom Tubing Pack with or without coating ( Carmeda BioA... Medtronic is initiating an Urgent Medical Device Customer Notification. We have confirmed that c... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Nov 13, 2012 The Vertex Max Drill Tube is a component within the Navigated Vertex Max Dril... Medtronic is recalling certain Vertex Max Drill Tubes which are used with the StealthStation Syst... Class II Medtronic Navigation, Inc.
Nov 9, 2012 Medtronic SynchroMed II, Model 8637, (The SynchroMed¿ II Pump is supplied in ... Medtronic notified Healthcare Professionals of the impact of unapproved drugs on the performance ... Class I Medtronic Neuromodulation
Nov 9, 2012 SynchroMed EL, models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10... Medtronic notified Healthcare Professionals of the impact of unapproved drugs on the performance ... Class I Medtronic Neuromodulation
Sep 19, 2012 Valiant Thoracic Stent Graft with Captivia Delivery System, Talent Thoracic ... Firm received reports of difficulty in flushing the graft cover of the delivery system during dev... Class II Medtronic Vascular, Inc.
Aug 30, 2012 ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE, REF 1... Lines on the screw gauge may not placed on the caddy properly which could result in improper meas... Class II Medtronic Sofamor Danek USA 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.