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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

1,646 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,646 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 1,646 FDA device recalls in MN.

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DateProductReasonClassFirm
Mar 15, 2013 Vitrea¿ CT Brain Perfusion made available in various configurations under the... Vital Images, Inc. (Vital Images) received one report about potential user confusion when viewing... Class II Vital Images, Inc.
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 1, 2013 AMS 800¿ Urinary Control System. The AMS 800¿ Urinary Control System is u... American Medical Systems, Inc. is initiating a recall on two components of the AMS 800¿ Urinary C... Class II American Medical Systems, Inc.
Mar 1, 2013 AMS 800¿ Urinary Control System. The AMS 800¿ Urinary Control System is ... American Medical Systems, Inc. is initiating a recall on two components of the AMS 800¿ Urinary C... Class II American Medical Systems, Inc.
Mar 1, 2013 Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generato... An internal protective fuse can be unintentionally activated while the device is charging its cap... Class II Boston Scientific CRM Corp
Feb 27, 2013 Vascular Solutions, Inc., Guardian II and Guardian II NC Hemostasis Valve, us... Risk that air may be introduced into the device which may lead to an air embolism. Class I Vascular Solutions, 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 11, 2013 Microbiologics KWIK-QC SLIDES ( KWIK-QC Acid Fast Stain Slides and KWIK-QC My... Microbiologics Inc is initiating a voluntary recall on products KWIK-QC Acid Fast Stain Slide, SL... Class II Microbiologics Inc
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
Feb 6, 2013 Smiths Medical, BCI¿ Remote Alarm Cable (Normally Open & Normally Closed), Re... In rare instances, the BCI¿ Remote Alarm Cables (BCI¿ Cable) are not transferring alarms when use... Class I Smiths Medical ASD, Inc.
Feb 5, 2013 Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) an... Vital Images has found a potential error in measurement generated through the software which aff... Class II Vital Images, Inc.
Jan 29, 2013 Vascular Solutions, SuperCross Microcatheter, Sterilized using ethylene oxide... Vascular Solutions, Inc has discovered a potential problem with a number of lots of Supercross m... Class II Vascular Solutions, Inc.
Jan 18, 2013 St. Jude Medical, AGA Medical corporation, AMPLATZER¿ TorqVue¿ FX Delivery Sy... The distal end of the core wire of the TorqVue FX Delivery System could potentially fracture when... Class I St Jude Medical Inc
Jan 16, 2013 45¿ Angle Driver / Z-H, Greatbatch Medical 10 000 Wahrie Drive, Clarance, NY ... Greatbatch Medical has initiated a global voluntary recall and market withdrawal of its entire Sm... Class II Greatbatch Medical
Jan 9, 2013 Esteem Programmer Model 6001, US and ISA, Model 3001 Dell E54XX, part of the ... Envoy Medical is conducting a voluntary correction of a limited number of Esteem Programmers, par... Class II Envoy Medical Corporation
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 12, 2012 Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog... Greatbatch Medical observed some anomalies of the inner lumen of the MobiCath Bi-Directional Guid... Class II Greatbatch Medical
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
Nov 5, 2012 Arobella Medical 6mm Qurette used with the Arobella Medical AR1000 Wound Ther... This recall has been initiated because the Arobella Medical 6mm Qurette Q07 Lot Numbers 0001 and ... Class II Arobella Medical, LLC
Oct 19, 2012 AMS AdVance" Male Sling System 720088-01 AMS AdVance" Male Sling System (US)... American Medical Systems¿ (AMS) is issuing a voluntary recall on a number of lots of the AdVance¿... Class II American Medical Systems, Inc.
Sep 24, 2012 Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog... We are notifying you of a potential interaction between therapeutic catheters and MobiCath Bi-Dir... Class II Greatbatch Medical
Sep 13, 2012 3M Steri-Vac Gas Sterilizer/Aerator models 5XL and 8XL. 3M Steri-Vac Gas S... 3M determined that the electrical grounding mechanism for the Steri-Vac 5XL and 8XL gas Sterilize... Class II 3M Company - Health Care Business
Sep 6, 2012 Boston Scientific, Z Flex 270, Steerable Sheath, Sterile EO, Rx only, Distri... During the investigation of four returned Z Flex 270 Steerable Sheaths that were used with cardia... Class II Greatbatch Medical
Aug 30, 2012 Guardian II Hemostasis Valve, Model 8210 and Guardian II NC Hemostasis Valve,... Vascular Solutions, Inc., became aware of a potential problem involving pouches missing a seal fr... Class II Vascular Solutions, Inc.
Aug 13, 2012 Software for Vitrea, Vitrea fX, and Vitrea Enterprise Suite (VES): VPMC... Vital Images has found two potential errors in calcium score values in restored snapshots of stud... Class II Vital Images, Inc.
Jul 20, 2012 Visual-ICE¿ Cryoablation System, Model FPRCH 6000 Product Usage: The Galil... Galil Medical is recalling a number of Visual Ice Cryoablation Systems because the gas regulators... Class II Galil Medical, Inc.
Jun 27, 2012 Mar Cor Purification CWP Reverse Osmosis System. Models 101, 102, 104, and 106. There exists a potential situation with the crimp connection at the pump head assembly. The pote... Class II Mar Cor Purification
Jun 26, 2012 BridgePoint Medical, Stingray Catheter, REF M - 1000, Sterilized with Ethyle... BridgePoint Medical Inc. is voluntarily recalling Stingray Catheter, Model M1000 lots BP20121440... Class II Bridgepoint Medical
Jun 19, 2012 CareFusion EnVe Ventilator Designed for use on patients who require respir... CareFusion identified that the EnVe Ventilator may not hold the set Positive End Expiratory Press... Class I CareFusion 203, Inc.
Jun 18, 2012 superDimension Systems AAS00016-xx with Software Version 4.0-4.9. Indicate... superDimension, Inc., is conducting a recall of certain superDimension Systems operating Software... Class II superDimension, Inc
Jun 18, 2012 CSI Stealth 360-degree Orbital Atherectomy Device (OAD), Part Number 70056-11... CSI has initiated a recall on specific lot numbers of Stealth 360-degree Orbital Atherectomy devi... Class II Cardiovascular Systems, Inc.
May 29, 2012 Microbiologics 217 Osseo Avenue North, St. Cloud, MN 56303, Gram Stain Contr... Microbiologics is recalling a number of lots of KWIK-QC Gram Stain Slides. This product gram neg... Class II Microbiologics Inc
Mar 28, 2012 Fast-Cath Transseptal Guiding Introducer, 90, 8F, REF 406586, Length 60 cm, S... St. Jude Medical is recalling a single batch of Fast Cath Transseptal Guiding Introducers which w... Class III St Jude Medical Inc
Feb 24, 2012 Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-01 used... Braemar has recently became aware of a battery related incident that occurred with EWT battery pa... Class II BRAEMAR, INC.
Feb 14, 2012 Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Versio... Smiths Medical has identified a software anomaly in the Medfusion 4000 Syringe Infusion Pump that... Class I Smiths Medical ASD, Inc.
Feb 9, 2012 Reusable, Self-Adhering TENS/NMES/FES electrodes Single Patient Use Only. ... Covidien is conducting a voluntary recall regarding specific lots of TENS electrodes because it w... Class II Covidien LLC dba Uni-Patch
Feb 9, 2012 Reusable, non-sterile, self-adhering electrodes for use with TENS/NMES, . Ma... Covidien is conducting a voluntary recall regarding specific lots of TENS electrodes because it w... Class II Covidien LLC dba Uni-Patch
Feb 9, 2012 Performa reusable and self-adhering TENS/NMES/FES stimulating electrodes, ... Covidien is conducting a voluntary recall regarding specific lots of TENS electrodes because it w... Class II Covidien LLC dba Uni-Patch
Feb 9, 2012 Empi STIMC RE Self Adhesive electrodes. For use on TENS, NMES, FES. a DJO b... Covidien is conducting a voluntary recall regarding specific lots of TENS electrodes because it w... Class II Covidien LLC dba Uni-Patch
May 2, 2011 Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-00 used... Braemar Inc., became aware of a battery related incident that occurred with an Able battery pack... Class II BRAEMAR, INC.
May 14, 2010 Medfusion Model 3500 Syringe Pump, Model #3500-415 and 3500-500. Intended ... An issue with the plunger rod seal was identified where the seal had the potential to migrate ins... Class II Smiths Medical ASD, 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.