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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

1,708 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
Apr 6, 2021 Programmers - Product Usage: used to treat arrhythmias related to bradycardia... A longevity estimation error may occur in the early years of device life when a unipolar pacing ... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Apr 6, 2021 CRT-P Quad Models (CRT-Ps): a. Percepta CRT-P MRI: W1TR01, W1TR04, W4TR01, W... There is a SmartSync software issue that results in an overestimation in the displayed longevity ... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Apr 6, 2021 Implantable Pulse Generators - Product Usage: used to treat arrhythmias relat... A longevity estimation error may occur in the early years of device life when a unipolar pacing ... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Apr 6, 2021 CareLink SmartSync Device Manager - Product Usage: used to treat arrhythmias ... A longevity estimation error may occur in the early years of device life when a unipolar pacing ... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Apr 6, 2021 CareLink SmartSync Device Manager (24970A). used to interrogate cardiac impl... There is a SmartSync software issue that results in an overestimation in the displayed longevity ... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Mar 25, 2021 Intellis Model 97755 Recharger - Product Usage: designed to charge the follow... There is a potential for unintended heating that can occur with the Intellis Model 97755 Recharger. Class II Medtronic Neuromodulation
Mar 23, 2021 VenaSeal Closure System Firm received increased number of reports that VenaSeal dispensing systems are not effectively ad... Class III Medtronic Inc.
Mar 17, 2021 Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 De... The shelf box identifies a small device actually contains a large device, and the shelf box ident... Class II Medtronic Sofamor Danek USA, Inc
Mar 17, 2021 Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 De... The shelf box identifies a small device actually contains a large device, and the shelf box ident... Class II Medtronic Sofamor Danek USA, Inc
Mar 16, 2021 Medtronic Abre Venous Self-expanding Sent System, Catalog number REF AB9U1608... Incorrect size printed on the device; packaging is labeled correctly. Class II Medtronic Inc.
Mar 15, 2021 MiniMed 780G Insulin Pump: Models: PUMP MMT-1885 MM780G 6.5V BLE MMOL;¿ PU... Due to a software design issue, under certain conditions, a software fault is detected when a lar... Class II Medtronic Minimed
Mar 15, 2021 MiniMed 670G Insulin Pump: Models: PUMP MMT-1740KX 670G V6.3 SF MG CLIN;¿ ... Due to a software design issue, under certain conditions, a software fault is detected when a lar... Class II Medtronic Minimed
Mar 9, 2021 A610 Clinician Programmer Application for Deep Brain Stimulation Clinician Pr... There are two issues within this correction action: 1. Cycling Issue: When copying settings fro... Class II Medtronic Neuromodulation
Mar 3, 2021 Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console, Model Numbers... An electrical component within the system controller module of certain Bio-Console 560 devices ma... Class I Medtronic Perfusion Systems
Feb 26, 2021 Medtronic, REF: MMT-7008D, Enlite Glucose Sensor for the following packaging:... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic REF: MMT-7020C1 Guardian Sensor (3) for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic REF: MMT-7008B, Enlite Glucose Sensor for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic, REF: MMT-7008A, Enlite Glucose Sensor for the following packaging:... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neopla... Class II Medtronic Inc.
Feb 26, 2021 Medtronic REF: MMT-7020C2 Guardian Sensor (3) for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic REF: MMT-7020C5 Guardian Sensor (3) for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic REF: MMT-7020D5 Guardian Sensor (3) for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic REF: MMT-7020LA, Guardian Sensor (3) for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanie... Medtronic HeartWare HVAD System Instructions for Use (IFU) and Patient Manual (PM) updates regard... Class I Heartware, Inc.
Feb 26, 2021 Medtronic REF: MMT-7020C4 Guardian Sensor (3) for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic HVAD Packaged Monitor, Model Numbers: 1500, 1500AU, 1500DE, 1510US... There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cable... Class I Heartware, Inc.
Feb 26, 2021 Medtronic REF: MMT-7020LB, Guardian Sensor (3) for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic REF: MMT-7020GA, Guardian Sensor (3) for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic HVAD Alarm Adapter, Product Number: 1450 There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cable... Class I Heartware, Inc.
Feb 26, 2021 Power Supply: 1. Medtronic HVAD Controller AC Adapter, Product Numbers: 142... There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cable... Class I Heartware, Inc.
Feb 26, 2021 Medtronic REF: MMT-7020D4 Guardian Sensor (3) for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic, REF: MMT-7008C, Enlite Glucose Sensor for the following packaging:... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic REF: MMT-7020D3 Guardian Sensor (3) for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic HVAD Monitor Data Cable, Product Number: 1575 There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cable... Class I Heartware, Inc.
Feb 26, 2021 Medtronic REF: MMT-7020D1 Guardian Sensor (3) for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic REF: MMT-7020A, Guardian Sensor (3) for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic HVAD Battery, Product Number: 1650, 1650CA-CLIN, 1650DE There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cable... Class I Heartware, Inc.
Feb 26, 2021 Medtronic REF: MMT-7020C3 Guardian Sensor (3) for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic REF: MMT-7020D2 Guardian Sensor (3) for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic REF: MMT-7020B, Guardian Sensor (3) for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic HVAD Controller, Product Numbers: 1400, 1401, 1401AU, 1401BR, 1401... There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cable... Class I Heartware, Inc.
Feb 26, 2021 Medtronic REF: MMT-7020C Guardian Sensor (3) kit for the following packaging:... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 12, 2021 Valiant Navion Thoracic Stent Graft System. For endovascular repair of lesio... Due to the presence of type IIIb endoleaks, stent fractures, and stent ring enlargement. Class I Medtronic Vascular, Inc.
Feb 4, 2021 Medtronic Custom Pack EVNP Clinical with AP40 1/B (PERFUSION M448036B 1/B). ... Products being recalled due to potentially elevated level of bacterial endotoxin. Patients expose... Class I Medtronic Perfusion Systems
Feb 4, 2021 Medtronic Affinity Pixie Hollow Fiber Oxygenator and Cardiotomy/Venous Reserv... Products being recalled due to potentially elevated level of bacterial endotoxin. Patients expose... Class I Medtronic Perfusion Systems
Feb 4, 2021 Custom Perfusion System (CUSTOM PACK BB10H89R4 ECLR). The Affinity Pixie Card... Products being recalled due to potentially elevated level of bacterial endotoxin. Patients expose... Class I Medtronic Perfusion Systems
Feb 4, 2021 Medtronic Affinity Pixie BP241 Hollow Fiber Oxygenator and Cardiotomy/Venous ... Products being recalled due to potentially elevated level of bacterial endotoxin. Patients expose... Class I Medtronic Perfusion Systems
Feb 4, 2021 Medtronic Custom Perfusion Pack (CUSTOM PACK HY11B40R1 1/4 RESPIRATO). The Af... Products being recalled due to potentially elevated level of bacterial endotoxin. Patients expose... Class I Medtronic Perfusion Systems
Feb 4, 2021 Custom Perfusion System (CUSTOM PACK BB7W03R8 CCSM NEON). The Affinity Pixie ... Products being recalled due to potentially elevated level of bacterial endotoxin. Patients expose... Class I Medtronic Perfusion Systems
Feb 4, 2021 Custom Perfusion System (CUSTOM PACK HY10J00R6 ECC SMALL CAR). The Affinity ... Products being recalled due to potentially elevated level of bacterial endotoxin. Patients expose... Class I Medtronic Perfusion Systems
Feb 4, 2021 Medtronic Custom Pack CP Kinderset 1/4-1/4 MIT Pixie 1/B (PERFUSION M490817B ... Products being recalled due to potentially elevated level of bacterial endotoxin. Patients expose... Class I Medtronic Perfusion Systems

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.