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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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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
Dec 13, 2016 Boston Scientific Imager II Angiographic Catheter, M001316581 (5-pack outer p... One lot of Imager II Angiographic Catheters is being recalled due to packaging mislabeling. The ... Class II Boston Scientific Corporation
Dec 9, 2016 Amplia MRI" CRT -D SureScan", Amplia MRI" Quad CRT -D SureScan", Claria M... During internal testing conducted as part of next generation product development, it was discover... Class II Medtronic Inc., Cardiac Rhythm and Heart Failure
Dec 9, 2016 Smiths Medical CADD Blue-Striped IV Administration Set, REF 21-7036-01, Steri... The label of the CADD Blue-Striped Administrative Set is missing the expiration date, which is co... Class II Smiths Medical ASD Inc.
Dec 7, 2016 DIAMONDBACK 360 Peripheral 1.50 Classic, Model DBP-150CLASS145 Peripheral Or... CSI discovered that a 1.50mm Solid Crown OAD was labeled as a 1.50mm Crown OED. Class II Cardiovascular Systems Inc
Nov 30, 2016 Ecolab, Microtek Rolled Probe Cover PC0907NB, Rx Only. The reason for the recall is that the inner carton box of the Rolled Probe Cover PC0907NB has the... Class III Ecolab Inc
Nov 30, 2016 Boston Scientific, INGEVITY" MRI Leads, Sterile EO, RxOnly. Boston Scientific is conducting a recall on Boston Scientific INGEVITY" MRI endocardial pacing le... Class II Boston Scientific Corporation
Nov 21, 2016 Acuvance¿2 Safety Catheter, Product No. 1720-AI Product Usage: The Acuvan... Smiths Medical became aware that three (3) lots of Acuvance2 Safety Catheter, product number 1720... Class II Smiths Medical ASD Inc.
Nov 16, 2016 Affinity Fusion" Oxygenator with Integrated Arterial Filter, Affinity Fusion... Medtronic is initiating a voluntary product recall for specific lot numbers of the Affinity Fusio... Class II Medtronic Inc
Nov 11, 2016 ViaPeel PTFE Peelable Introducer 5FR, Part Number 10890-006 Greatbatch received complaints with the ViaPeel Introducer Sheath 5FR, of handles detaching durin... Class II Greatbatch Medical
Nov 10, 2016 ev3, PowerCross .018 OTW PTA Dilatation Catheter, Sterile EO. The PowerCross... Medtronic identified an issue with specific models and lots of the PowerCross .018 Over the Wire... Class II Medtronic Inc
Oct 31, 2016 CADD Solis VIP Ambulatory Infusion Pump, Model 21-21210, Reorder 21-2120-0102... 20 Pumps sold to the Finnish market contain a message in which one word in the message is mistran... Class II Smiths Medical ASD, Inc.
Oct 31, 2016 HOTLINE Blood and Fluid Warmer, Mole l HL-90. Designed for use with the Hotl... HOTLINE Blood and Fluid Warmers included Greek and Danish language labeling instead of the requir... Class III Smiths Medical ASD, Inc.
Oct 26, 2016 3M Universal Electrosurgical Pad, REF 9130 (100 pads / case) and 3M Univer... 3M is recalling Universal Electrosurgical Pads because a report of an unintended material (proces... Class II 3M Company - Health Care Business
Oct 25, 2016 NORMFlow H-110 Irrigation Fluid Warmer, Continental Europe, Model H-1100, Reo... Smiths Medical became aware that that one (1) NORMOFLO¿ H-1100 Irrigation Fluid Warmers was incor... Class II Smiths Medical ASD, Inc.
Oct 20, 2016 Nordson Micromedics FibriJet Endoscopic Catheter Introducer, Catalog Number S... The sterile packaging may contain small channels in the seal of the pouch, If the channels are p... Class II Micromedics, Inc.
Oct 19, 2016 Offset Reamer Handle, T5766 Product Usage: The reamer handles are re-usab... On June 14, 2016, Greatbatch discovered a significant increase in the number of field complaints ... Class II Greatbatch Medical
Oct 11, 2016 Algovita Spinal Cord Stimulation System, Percutaneous Leads, 8-Electrode Per... Nuvectra is conducting a recall due to two clinical risks that are associated with certain percu... Class II Nuvectra
Oct 3, 2016 Model 37751 Recharger Product Usage: The Medtronic 37751 Recharger is a h... Medtronic has identified an increased number of complaints from customers involving reports of Re... Class II Medtronic Neuromodulation
Oct 3, 2016 Medtronic SynchroMed II Implantable Drug Infusion System. This system includ... Medtronic is following up to a May 2013 communication regarding the Priming Bolus function for th... Class I Medtronic Neuromodulation
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

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.