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Browse Device Recalls

1,680 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,680 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 1,680 FDA device recalls.

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DateProductReasonClassFirm
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
Feb 4, 2021 Medtronic Custom Pack CP 1/4-1/4 Pediatric Set 1/B (PERFUSION M484901D 1/B). ... Products being recalled due to potentially elevated level of bacterial endotoxin. Patients expose... Class I Medtronic Perfusion Systems
Feb 4, 2021 Medtronic Custom Pack Infant Tubingset Pixie Flow 0,8->1,5-1,8 1/B (PERFUSION... Products being recalled due to potentially elevated level of bacterial endotoxin. Patients expose... Class I Medtronic Perfusion Systems
Feb 3, 2021 Implantable cardioverter defibrillators (ICD): 1) Evera family: Evera XT DR,... A small percentage of implanted cardiac devices, from a well-defined subset, may experience a sho... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
Feb 3, 2021 Implantable cardioverter defibrillators (ICD) with cardiac resynchronization ... A small percentage of implanted cardiac devices, from a well-defined subset, may experience a sho... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jan 15, 2021 Medtronic 6F Launcher Guide Catheter 100 cmJL 3.5 Model Number: LA6JL35 Sterility may be compromised due to an unsealed pouch Class II Medtronic Vascular
Jan 15, 2021 Medtronic 6F Launcher Guide Catheter 100 cm JR 4.0 Model Number: LA6JR40 Sterility may be compromised due to an unsealed pouch Class II Medtronic Vascular
Jan 15, 2021 Medtronic 6F Launcher Guide Catheter 100cm EBU 3.75 Model Number: LA6EBU375 Sterility may be compromised due to an unsealed pouch Class II Medtronic Vascular
Jan 15, 2021 Medtronic 6F Launcher Guide Catheter 100 cm EBU 3.0 Model Number: LA6EBU30 Sterility may be compromised due to an unsealed pouch Class II Medtronic Vascular
Jan 11, 2021 Medtronic Delta CSF (Cerebro Spinal Fluid) -Flow Control Valves for the foll... Potential for variation in radiopaque marking visibility under radiographic imaging for adjustabl... Class II Medtronic Neurosurgery
Jan 11, 2021 Medtronic PS Medical Cerebro Spinal Fluid (CSF)-Flow Control Valves for the... Potential for variation in radiopaque marking visibility under radiographic imaging for adjustabl... Class II Medtronic Neurosurgery
Jan 11, 2021 Medtronic Cerebro Spinal Fluid Flow Control Valves and Shunts. STRATA II V... Potential for variation in radiopaque marking visibility under radiographic imaging for adjustabl... Class II Medtronic Neurosurgery
Dec 16, 2020 REF 27219-1 X1, Medtronic, Delta Valve, Neonatal, Performance Level 1.0, CE ... Neonatal Valves were manufactured with a ventricular catheter connection site shorter than the de... Class II Medtronic Neurosurgery
Dec 16, 2020 REF 27219-5 X1, Medtronic, Delta Valve, Neonatal, Performance Level 1.5, CE ... Neonatal Valves were manufactured with a ventricular catheter connection site shorter than the de... Class II Medtronic Neurosurgery
Dec 16, 2020 REF 27219-2 X1, Medtronic, Delta Valve, Neonatal, Performance Level 2.0, CE ... Neonatal Valves were manufactured with a ventricular catheter connection site shorter than the de... Class II Medtronic Neurosurgery
Dec 8, 2020 Medtronic Ares Antibiotic-Impregnated Catheter, REF: 93092, Sterile, Rx Only.... There is a potential for a defect on the seal of the outer pouch of catheters. The defect may com... Class II Medtronic Neurosurgery
Dec 8, 2020 Medtronic Ares Antibiotic-Impregnated Catheter, REF: 91101, Sterile, Rx Only.... There is a potential for a defect on the seal of the outer pouch of catheters. The defect may com... Class II Medtronic Neurosurgery
Dec 8, 2020 Medtronic Ares Antibiotic-Impregnated Catheter, REF: 95001, Sterile, Rx Only.... There is a potential for a defect on the seal of the outer pouch of catheters. The defect may com... Class II Medtronic Neurosurgery
Nov 19, 2020 Medtronic HVAD Pump Implant Kits, labeled as: a. PUMP 1103, b. PUMP 1104, ... Pumps manufactured with impellers from a subset of lots from a single supplier are failing to ini... Class I Heartware, Inc.
Nov 19, 2020 Percept PC Implantable Neurostimulator (INS) - Product Usage: The Percept PC ... A software anomaly in the A620 Patient Programmer application was identified that results in fail... Class II Medtronic Neuromodulation
Nov 15, 2020 Medtronic COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, MR Conditi... Under rare circumstances, the component may be susceptible to a failure mechanism that could impa... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Nov 15, 2020 Medtronic Cobalt HF CRT-D MRI SureScan DTPB2D1, MR Conditional implantable ca... Under rare circumstances, the component may be susceptible to a failure mechanism that could impa... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Nov 15, 2020 Medtronic Cobalt DR MRI SureScan DDPB3D1, MR Conditional implantable dual cha... Under rare circumstances, the component may be susceptible to a failure mechanism that could impa... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Nov 12, 2020 Medtronic Intellis Spinal Cord Stimulator, Model Number A710, Clinical Progra... A710 Intellis Clinician Application has a software issue that can result in the inability to prog... Class II Medtronic Neuromodulation
Nov 12, 2020 CareLink Personal Software Therapy Management Software Tool for Diabetes Car... Incomplete basal rate information may be transmitted leading to a potential for inappropriate cha... Class II Medtronic Inc.
Nov 5, 2020 Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization... Manufacturing error that may have resulted in a cathode component being out of specification. Al... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Oct 23, 2020 Evolut (TM) R System. With the following model numbers: a. EVOLUTR-23, ... Potential for Transcatheter Aortic Valve (TAV) leaflet damage when performing a post-implant ball... Class II Medtronic Heart Valves Division
Oct 23, 2020 Evolut (TM) PRO+ System. With the following model numbers: a. EVPROPLUS... Potential for Transcatheter Aortic Valve (TAV) leaflet damage when performing a post-implant ball... Class II Medtronic Heart Valves Division
Oct 23, 2020 Evolut (TM) PRO System. With the following model numbers: a. EVOLUTPRO-... Potential for Transcatheter Aortic Valve (TAV) leaflet damage when performing a post-implant ball... Class II Medtronic Heart Valves Division

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.