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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
Sep 17, 2014 Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillat... Boston Scientific identified a subset of COGNISTM CRT-Ds and TELIGENTM ICDs that had experienced ... Class II Boston Scientific CRM Corp
Sep 8, 2014 Biatain Super Non-Adhesive, Catalog number 46300, 10 pcs, REF 0463001400. Cou... Coloplast is conducting a recall for one lot (4201931) of the Biatain Super Non-Adhesive wound d... Class III Coloplast Manufacturing US, LLC
Aug 27, 2014 GYRUS ACMI, REF 3345 -Everest BiCOAG MOLly Forceps 5mm/45cm REF 3345PK - PKS... Due to an anomaly in the packaging process, it is possible that a defective seal could be present... Class II Gyrus Medical, Inc
Aug 8, 2014 CareFusion EnVe and ReVel Ventilators. The EnVe/ ReVel Ventilator is desig... CareFusion has identified a potential for damage to the power connector on the EnVe and ReVel ven... Class I CareFusion 203, Inc.
Jul 14, 2014 Medtronic, Activa PC, Model 37601, Method of Sterilization: Ethylene Oxide, S... Medtronic is recalling six Activa PC (model 37601) Implantable Neurostimulators due to the potent... Class II Medtronic Neuromodulation
Jul 11, 2014 Medtronic Ascenda Intrathecal Catheter models 8780 and 8781, and Ascenda Intr... Medtronic is removing specific lots of the Ascenda Intrathecal Catheters and Revision Kits, which... Class II Medtronic Neuromodulation
Jul 8, 2014 Gyrus ACMI Falope-Ring Dilator, item 000878-4. The Falope-Ring Dilator is a ... Falope-Ring Dilator for Reusable Falope-Ring Band Applicators have been sold as a stand-alone non... Class II Gyrus Medical, Inc
Jun 20, 2014 LP,Surgical Fibers, Bare Laser Fiber 600 micron, DBLF-60-2, Sterile EO. L... Laser Peripherals LLC is recalling DBLF-60-2 Bare Laser due to a mislabeling that indicated a s... Class II Laser Peripherals LLC
Jun 19, 2014 Boston Scientific ENDOTAK RELIANCE¿ SG, transvenous defibrillation lead, Mode... A review of manufacturing test records for Boston Scientific ENDOTAK RELIANCE implantable leads ... Class II Boston Scientific CRM Corp
Jun 11, 2014 Medtronic Nexdrive Micropositioning Drive. Models Ml-1000 and Ml-2000. F... Potential for misalignment of the Z-stage scale. Using one of these devices for a procedure could... Class II Medtronic Neuromodulation
Jun 9, 2014 3M Attest Auto-reader. Model numbers 390, 390G,and 490. These device... Labeling on units shipped prior to May 16th, 2014 did not contain the statement "This product con... Class II 3M Company - Health Care Business
Jun 4, 2014 Stride Femoral Component Size 2, PFSI-00054, Right Medial /Left Lateral. Unic... Mislabeled. Packages labeled PFSI-00053, Right Lateral/Left Medial contains PFSI-00054, Right Me... Class II Blue Belt Technologies MN
Jun 4, 2014 Stride Femoral Component Size 2, PFSI-00053, Right Lateral /Left Medial. Unic... Mislabeled. Packages labeled PFSI-00053, Right Lateral/Left Medial contains PFSI-00054, Right Me... Class II Blue Belt Technologies MN
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 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 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 12, 2014 Armstrong Grommet with wire Otological Ventilation Tube Catalog #: VT-0507-... One lot of ventilation tubes have mixed tubes with wire attached to the slanted flange and ventil... Class II Summit Medical, Inc.
May 2, 2014 Medtronic Model 8780 Ascenda Intrathecal Catheter. The implantable Medtron... Medtronic has determined that an Ascenda catheter kit may have had endotoxin in excess of USP lim... Class II Medtronic Neuromodulation
Apr 29, 2014 Medtronic Temporary Pacemaker, Model 5348. Single Chamber External Pulse Gene... Events related to a pacing rate outside of the intended setting, including events of sudden incre... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Apr 28, 2014 Coaxial Micro-Introducer Kit. Greatbatch Part Number/Bard Access Systems O... Greatbatch identified that the documentation does not support the five-year shelf life of the Bar... Class II Greatbatch Medical
Apr 24, 2014 Mar Cor Purification, Central Water Platform (CWP), 102, 104 and 106. Pro... Mar Cor Purification manufactured Central Water Plant (CWP) reverse osmosis system, models 102, 1... Class II Mar Cor Purification
Apr 11, 2014 NavioPFSTM System, Orthopedic Sterotaxic Instrument, model #'s NPFS-02000, N... Blue Belt Technologies is conducting a voluntary recall for their Navio PFS system which is used ... Class II Blue Belt Technologies MN
Apr 9, 2014 ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 120mm x 135cm, REF:... Covidien is recalling 2 production lots of EverCross 0.035 PTA Balloon Catheter because of a prod... Class II Ev3, Inc.
Apr 4, 2014 Refill Kit 8551/856X (includes Models 8561, 8562 and 8564) for use with Medtr... Some refill kits in the affected lots may contain an extension tubing set that is occluded and he... Class II Medtronic Neuromodulation
Mar 31, 2014 Boston Scientific, NovaGold High Performance Guidewire, Rx only, Sterilized u... Neo Metrics, Inc. is recalling NovaGold Guidewire because the tip may uncoil and / detach more fr... Class II NEO METRICS, INC.
Mar 17, 2014 3M" Steri-Vac" Gas Sterilizer/Aerators, Model #'s 4XL,5XL, 8XL The 3M" Ste... Recently, 3M received a single report of a potential exposure to Ethylene Oxide (EO) at a hospita... Class II 3M Company - Health Care Business
Mar 14, 2014 InterValve V8 Balloon Aortic Valvuloplasty Catheter, model 172212C110, 19241... Leak issues were discovered through accelerated age testing. Class II InterValve Inc
Mar 3, 2014 Boston Scientific, RunWay Guide Catheter, UPN H749389696640, Catalog Number 3... The sterile pouch of the devices from this lot may not be completely sealed and sterility may be ... Class II Boston Scientific Corporation
Feb 27, 2014 Medtronic, External neurostimulator, ENS (37021) & ENS (37022). Including t... Medtronic neurostimulators (used with pain and deep brain stimulation therapy) have a cycling fea... Class II Medtronic Neuromodulation
Feb 27, 2014 Medtronic neurostimulators. Restore (37711), RestoreADVANCED (37713), Restore... Medtronic neurostimulators (used with pain and deep brain stimulation therapy) have a cycling fea... Class II Medtronic Neuromodulation
Feb 27, 2014 Medtronic Activa RC (37612), Activa PC (37601), Activa SC (37602), Activa SC... Medtronic neurostimulators (used with pain and deep brain stimulation therapy) have a cycling fea... Class II Medtronic Neuromodulation
Feb 26, 2014 Medtronic SynchroMed¿ II Implantable Drug Infusion Pump, Model 8637-20, 8637-... This recall provides important new information regarding overinfusion associated with the Medtron... Class II Medtronic Neuromodulation
Feb 19, 2014 Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and R... Due to an anomaly in the packaging process for specific lots of Disposable Falope-Ring Band Kit, ... Class II Gyrus Medical, Inc
Feb 4, 2014 Boston Scientific, Coyote" MONORAIL" PTA Balloon Dilatation Catheter, UPN # H... Boston Scientific is initiating this Recall Removal of one lot of the Coyote" OVER-THE-WIRE PTA B... Class II Boston Scientific Corporation
Feb 4, 2014 Boston Scientific, 2.5mm Coyote" OVER-THE-WIRE PTA Balloon Dilation Catheter,... Boston Scientific is initiating this Recall Removal of one lot of the Coyote" OVER-THE-WIRE PTA B... Class II Boston Scientific Corporation
Jan 31, 2014 Greatbatch Medical, Offset Cup Impactor. Part Numbers: P9485, T10243, T1028... Greatbatch Medical has initiated a global Field Corrective Action for the Standard Offset Cup Imp... Class I Greatbatch Medical
Jan 31, 2014 Otto Bock Aerial and Aerial Active Wheelchair Cushions. Material numbers: S... Otto Bock is recalling all Aerial and Aerial Active Wheelchair Cushions from specific material nu... Class II Bock,Otto,Orthopedic Ind,Inc
Jan 30, 2014 Medtronic Select CAP Arterial Cannulae. Vented, models 78818 (18 Fr.), 7882... Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product famili... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Jan 30, 2014 Medtronic Select 3D Arterial Cannulae. Vented, model 78622 (22 Fr.). Non-V... Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product famili... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Jan 30, 2014 Medtronic Intersept Custom Tubing Pack which contain Select 3D or Select CAP ... Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product famili... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Jan 30, 2014 Medtronic Select 3D Arterial Cannulae. Vented, model 78624 (24 Fr.). Non-V... Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product famili... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Jan 30, 2014 Medtronic Select 3D Arterial Cannulae. Vented, models 78618 (18 Fr.) and 78... Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product famili... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Jan 30, 2014 Medtronic Select CAP Arterial Cannulae. Non-Vented, Carmeda Coated, model CB... Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product famili... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Jan 27, 2014 CSI, Diamondback 360 Coronary Orbital Atherectomy System, Part Number 70058-0... Cardio vascular Systems Inc. has initiated a recall to request the immediate removal and return o... Class III Cardiovascular Systems, Inc.
Nov 22, 2013 Medfusion¿ 4000 Syringe Infusion Pumps Medfusion¿ 4000 Syringe Infusion Pu... Smiths Medical is conducting a recall involving all Medfusion¿ 4000 Syringe Infusion Pumps. Smi... Class II Smiths Medical ASD, Inc.
Nov 21, 2013 3M ESPE Imprint II Regular Body , Catalog Number 9379, and Paradigm Regular B... Specific lots of Imprint II and Paradigm impression material refill packs are being recalled beca... Class II 3M Company - Health Care Business
Oct 28, 2013 Dura Guard, Dural Repair Patch with Apex Processing. For use as a dura sub... Synovis, a subsidiary of Baxter International Inc., is recalling certain shipments of VASCUGUARD ... Class II Synovis Surgical Innovations, Inc.
Oct 28, 2013 Vascu Guard, Peripheral Vascular Patch with Apex Processing. For use in pe... Synovis, a subsidiary of Baxter International Inc., is recalling certain shipments of VASCUGUARD ... Class II Synovis Surgical Innovations, Inc.
Oct 21, 2013 Prostiva RF Therapy Hand Piece Kit, REF 8929, Rx only, sterilized using Ethyl... A Hand Piece high deployment force exceeded the maximum specification. Class II Urologix, Inc.
Oct 21, 2013 VitreaCore¿ software. Versions subject to the limitation: 6.0, 6.1, 6.2, 6.3... Vital Images, Inc. has found an issue in VitreaCore software though internal testing. There is a... Class II Vital Images, 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.