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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

1,677 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,677 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 1,677 FDA device recalls in MN.

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DateProductReasonClassFirm
Sep 29, 2016 8500M Handheld Pulse Oximeter Nonin manufactures and sells two 8500 handheld pulse oximeters (Model 8500 with no memory feature... Class II Nonin Medical, Inc
Sep 19, 2016 Aequalis Fx2 implant parts and instrument trays. Insert component : Part ... Tornier is conducting a recall on Aequalis Fx2 ( implant parts and instrument trays) due to repo... Class II Tornier, Inc
Sep 16, 2016 Vascular Solutions Twin-Pass Dual Access Catheter, models 5200, 5210, and 523... Vascular Solutions is recalling Twin-Pass dual access catheters because there is a potential for... Class I Vascular Solutions, Inc.
Sep 16, 2016 Vascular Solutions Twin-Pass RX Dual Access Catheter, model 5210. Sterilized... Vascular Solutions is recalling Twin-Pass dual access catheters because there is a potential for... Class I Vascular Solutions, Inc.
Sep 16, 2016 Vascular Solutions Twin-Pass .023" Dual Access Catheter, model 5230. Sterili... Vascular Solutions is recalling Twin-Pass dual access catheters because there is a potential for... Class I Vascular Solutions, Inc.
Sep 8, 2016 Greatbatch Stiffer Coaxial Micro-Introducer. Model #/ Name: 10904-001 Stiffer... Greatbatch Medical has identified an issue with the Stiffer Coaxial Micro-Introducer 4FR and 5FR ... Class II Greatbatch Medical
Aug 24, 2016 R&D Systems, Quantikine¿ IVD¿sTfR Immunoassay Kit, for the quantitative deter... R&D Systems, Inc. received two customer complaints that results of the Controls provided with the... Class II R & D Systems, Inc.
Aug 12, 2016 Medtronic, Evera Implantable Cardioverter Defibrillators: Product Mo... 78 Viva CRT -Ds and Evera ICDs that were manufactured with a specific subset of circuit component... Class II Medtronic Inc., Cardiac Rhythm and Heart Failure
Aug 12, 2016 Medtronic, Viva Quadripolar Implantable Cardioverter Defibrillators: Product... 78 Viva CRT -Ds and Evera ICDs that were manufactured with a specific subset of circuit component... Class II Medtronic Inc., Cardiac Rhythm and Heart Failure
Aug 2, 2016 Greatbatch, Offset Cup Impactor with the following Parts and Catalogue #: T... On December 17, 2015, Greatbatch discovered that the Standard Offset Cup Impactor with a POM-C ha... Class I Greatbatch Medical
Jul 14, 2016 Microtek Franz Angiography Drape with Radiation Shield, Item # RBA202, and Mi... Ecolab is recalling 2 models of Angiography Drapes with Radiation Shields because the sterile pac... Class II Ecolab Inc
Jul 13, 2016 LIAISON Estradiol II Gen, 310680, 310680-CN The DiaSorin LIAISON Estradiol... DiaSorin is issuing an urgent medical device correction for the LIAISON¿ Estradiol II Gen assay. ... Class II Diasorin Inc.
Jun 23, 2016 DBS Pocket Adaptor, Model 64001 and Model 64002. The Medtronic Models 6400... Due to the potential for pocket adaptor conductor wire fractures involving DBS Pocket Adaptor Mod... Class II Medtronic Neuromodulation
Jun 16, 2016 Medtronic, Temporary Pacing Lead System, Model 6416, Sterile EO. Product Cat... This Pacing Lead System does not comply with Section 8.5.2.3 of IEC 60601-1, and corresponding pr... Class II Medtronic Inc., Cardiac Rhythm and Heart Failure
Jun 15, 2016 Pacemakers: Accolade MRI DR Model L311; Accolade MRI DR EL Model L331; and E... Five Accolate MRI and Essentio MRI DR pulse generators with an alternate MICS module configuratio... Class II Boston Scientific Corporation
Jun 13, 2016 ViperWire Advance Peripheral Guide Wire, Sterilized with Ethylene Oxide, Rx O... The pouch label was missing the use by date (UBD) of 2018-04. Class II Cardiovascular Systems Inc
Jun 10, 2016 Medtronic, Lead Kit for DBS Stimulation. Model Numbers 3387S-40 (p/n 3387S000... Medtronic has voluntarily decided to retrieve unused Model 3387S-40 and 3389S-40 DBS leads from t... Class II Medtronic Neuromodulation
May 26, 2016 Medtronic, MyCareLink Patient Monitor, Model 24950, Rx Only. The MyCareLink ... Recently, a new software version was automatically sent to a subset of Model 24950 MyCareLink Mon... Class II Medtronic Inc., Cardiac Rhythm and Heart Failure
May 23, 2016 EV3 EverFiex" Self-expanding Peripheral Stent System, Sterilized using Ethyl... Medtronic is issuing a medical device recall to return product potentially associated with an out... Class II Ev3, Inc.
May 3, 2016 Medtronic RestoreSensor, Model 37714; and, RestoreSensor SureScan, (MRI), Mod... Loss of therapy during recharging of device. Reportedly, a charging session was terminated prior ... Class II Medtronic Neuromodulation
Apr 26, 2016 Torque Limiting Adapter: Torque Limiting Attachment, Non Sterile, Distribute... Greatbatch Medical has initiated a global Field Recall for Torque Limiting Devices. Greatbatch i... Class II Greatbatch Medical
Apr 26, 2016 Reprocessed Microline Scissor Tips intended to be used with a reusable hand p... Sterlilmed is recalling all unexpired Scissor Tips because of a potential manufacturing defect th... Class II STERILMED, INC.
Apr 26, 2016 Torque Limiting Handle: PRECIMED, T-Handle Torque, Non Sterile. Handle: ... Greatbatch Medical has initiated a global Field Recall for Torque Limiting Devices. Greatbatch i... Class II Greatbatch Medical
Apr 26, 2016 Torque Limiting Screwdriver: Greatbatch Medical, Torque Limiting Driver, N... Greatbatch Medical has initiated a global Field Recall for Torque Limiting Devices. Greatbatch i... Class II Greatbatch Medical
Apr 22, 2016 CADD Administration Sets with Flow Stop, Product Reorder No: 21-7321-01, 21-... Smiths Medical became aware that under delivery of medication may occur on CADD Administration Se... Class II Smiths Medical ASD, Inc.
Apr 6, 2016 Nuvectra, Algovita Spinal Cord Stimulation System Clinical Programmer, Model ... If used, the optional Swap feature copies programming parameters from the external pulse generato... Class II Nuvectra
Apr 5, 2016 Germ Terminator, Toothbrush Steam Sterilization for Oral Health. Model GT100... CEG Enterprises, LLC is recalling Germ Terminator Toothbrush Sanitizer GT100 due to the following... Class II Ceg Enterprises Llc
Mar 31, 2016 Medtronic CareLink" Monitor (2490C) and Medtronic CareLink Express" Monitor (... A recent firmware update developed by Medtronic for the 2490C CareLink Monitors and 2020B CareLin... Class II Medtronic Inc., Cardiac Rhythm and Heart Failure
Mar 29, 2016 ev3, PowerCross" 0.018" OTW PTA Dilatation Catheter, model: AB18W030200150, S... Medtronic is conducting a voluntary Urgent Medical Device Recall of two lots of the PowerCross 0.... Class II ev3, Inc.
Mar 28, 2016 Boston Scientific, PT Graphix Magnet J-TIP Guidewire with ICE Hydrophilic Co... Boston Scientific is voluntarily implementing a Medical Device Recall of one batch of PT Graphix ... Class II Boston Scientific Corporation
Mar 25, 2016 NeuroBlate System SideFire Select 2.2 mm Directional Laser Probe, Sterile EO... Monteris received a report that the sapphire lens on a 2.2SF probe fractured during a LITT proced... Class I Monteris Medical Corp
Mar 22, 2016 Self-Cath¿ Pediatric Catheter Size CH 06, Product # 5044101400, Catakig # 30... Coloplast Corp. is voluntarily recalling a single lot of Self-Cath Pediatric French Size CH 06 ca... Class II Coloplast Manufacturing US, LLC
Mar 22, 2016 Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. P... Boston Scientific is recalling all models of Fetch 2 Aspiration Catheter as a result of receiving... Class I Boston Scientific Corporation
Mar 4, 2016 Guardian II Hemostasis Valve, models 8210 and 8211. The following models are... Vascular Solutions became aware of a potential problem with the click version of the Guardian II ... Class I Vascular Solutions, Inc.
Feb 23, 2016 Reveal LINQ insertable Cardiac Monitor, Model LNQ11. Monitors subcutaneous E... Medtronic has identified an issue with the sensitivity of an algorithm used in the Reveal LINQ IC... Class II Medtronic Inc.
Feb 12, 2016 Universal Clamp¿ System (IFU reference: SNA027-N-90001). Provides the stab... Zimmer Biomet is initiating a Medical Device Correction Notice to provide updated cleaning and di... Class II Zimmer Spine, Inc.
Feb 12, 2016 Instinct¿ Java¿ System (IFU reference: 046WAN0000T) . Stabilizes one or mo... Zimmer Biomet is initiating a Medical Device Correction Notice to provide updated cleaning and di... Class II Zimmer Spine, Inc.
Feb 10, 2016 Intra operative MRI Systems: Neuro II-SE , Neuro III-SV, iMRI 1.5T A, and iMR... Emergency helium venting lines (i.e. quench lines) may not have been properly installed. Class II Deerfield Imaging
Feb 9, 2016 Medtronic, Model 8781 Ascenda" Intrathecal Catheter kit, Rx Only, Sterile Eth... Medtronic Neuromodulation is initiating a voluntary removal of a single Model 8781 Ascenda" Intra... Class II Medtronic Neuromodulation
Feb 4, 2016 Medtronic Custom Perfusion Tubing Pack, Rx, Sterile EO. Terumo Cardiovascu... Medtronic is notifying customers who have or may receive specific lots of Medtronic Perfusion Tub... Class III Medtronic Perfusion Systems
Feb 3, 2016 Virage OCT Spinal Fixation System. Intended to promote fusion of the Occipi... Zimmer Biomet Spine is initiating a Medical Device Correction regarding the Virage OCT Spinal Fix... Class II Zimmer Spine, Inc.
Feb 1, 2016 Ellex Medical Fixed eye Safety filters Model Integre S LP5532. The filter... The Firm discovered that there is a design error which is traceable back to 2012 when a design ch... Class II Laserex Systems Inc.
Jan 26, 2016 Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2412 ( 2 x... The implantable pulse generator (IPG) model 2408 had suboptimal performance establishing a conne... Class II QiG Group LLC
Jan 26, 2016 Algostim LLC, Algovita External Pulse Generator, Trial Stimulator, Model 3400 The implantable pulse generator (IPG) model 2408 had suboptimal performance establishing a conne... Class II QiG Group LLC
Jan 26, 2016 Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2408 ( 3 x... The implantable pulse generator (IPG) model 2408 had suboptimal performance establishing a conne... Class II QiG Group LLC
Jan 22, 2016 3M Steri-Vac Gas Sterilizer/Aerator, models 5XL and 8XL. 3M discovered a valve with incorrectly labeled "input" and "output" orientation. This defect can... Class II 3M Company - Health Care Business
Jan 11, 2016 Specify 5-6-5 Lead, Specify 2x8 Lead, Model Numbers: 39565, 39286. Spinal co... Some Specify 5-6-5 and 2x8 surgical lead product labeling does not adequately distinguish between... Class II Medtronic Neuromodulation
Dec 21, 2015 ACIST Medical Systems, BT2000 Automated Manifold Kit (SKU 014613) and CPT20... Reports related to ingress of air into the manifold. Class II Acist Medical Systems
Dec 18, 2015 arkray SPOTCHEM II Glucose Reagent test strips, Item No. 77101, MEDTEST DX Ca... One lot each of SPOTCHEM II Basic PANEL-1 Reagent Test Strip and SPOTCHEM II Glucose Reagent Test... Class I Arkray Factory USA, Inc.
Dec 18, 2015 arkray SPOTCHEM II Basic Panel - 1 Reagent test strips, Product # 11726, MEDT... One lot each of SPOTCHEM II Basic PANEL-1 Reagent Test Strip and SPOTCHEM II Glucose Reagent Test... Class I Arkray Factory 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.