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
Nov 18, 2020 IceSeed" 1.5¿ MRI 90¿ Cryoablation Needle ¿ Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 IcePearl" 2.1 CX Prostate Cryoablation Kit Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 IceRod" 1.5 MRI 90¿ Cryoablation Needle¿ Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 IceRod" i-Thaw" Prostate Cryoablation Kit Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 IceSeed" Prostate Cryoablation Kit Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 IceRod" He-Thaw Prostate Cryoablation Kit Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 IceFORCE" 2.1 CX L 90¿ Cryoablation Needle Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 IceSphere" 1.5 Cryoablation Needle Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 IceFORCE" 2.1 CX Cryoablation Needle Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 IceRod" i-Thaw" Prostate Cryoablation Kit Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 IceRod" 1.5 Cryoablation Needle Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 IceRod" Prostate Cryoablation Kit Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 IceRod" 1.5 PLUS Cryoablation Needle Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 IceSphere" 1.5 90¿ Cryoablation Needle Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 Three IceFORCE" 2.1 CX Prostate Cryoablation Kit Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 IceRod" 1.5 90¿ Cryoablation Needle Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 IceFORCE" 2.1 CX Prostate Cryoablation Kit Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 IceRod" 1.5 MRI Cryoablation Needle¿ Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 IcePearl" 2.1 CX L 90¿ Cryoablation Needle Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 Three IcePearl" 2.1 CX Prostate Cryoablation Kit Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 IceSeed" Prostate Cryoablation Kit Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 IceEDGE" 2.4¿ 90p¿ Cryoablation Needle Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 Five IceRod" i-Thaw" Prostate Cryoablation Kit Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 IceRod" 1.5 PLUS 90¿ Cryoablation Needle Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 IceFORCE" 2.1 CX 90¿ Cryoablation Needle Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 IceSphere" 1.5 S 90¿ Cryoablation Needle Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 IceSphere" 1.5 Cryoablation Needle Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 IceSphere" 1.5 CX 90¿ Cryoablation Needle Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 IceSeed" 1.5 MRI Cryoablation Needle Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 IceSeed" 1.5 90¿ Cryoablation Needle Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 IceRod" 1.5 i-Thaw" Cryoablation Needle Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 IcePearl" 2.1 CX Cryoablation Needle Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 Five IceSphere" Prostate Cryoablation Kit Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 IceRod" 1.5 CX 90¿ Cryoablation Needle¿ Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 IcePearl" 2.1 CX 90¿ Cryoablation Needle Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 IceSeed" 1.5 Cryoablation Needle Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 17, 2020 Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on ... Failure to execute the visual inspection correctly prior to locking the valve during the deployme... Class I Boston Scientific Corporation
Nov 17, 2020 Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on ... Failure to execute the visual inspection correctly prior to locking the valve during the deployme... Class I Boston Scientific Corporation
Nov 17, 2020 Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on ... Failure to execute the visual inspection correctly prior to locking the valve during the deployme... Class I Boston Scientific Corporation
Nov 17, 2020 Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on ... Failure to execute the visual inspection correctly prior to locking the valve during the deployme... Class I Boston Scientific Corporation
Nov 17, 2020 Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on ... Failure to execute the visual inspection correctly prior to locking the valve during the deployme... Class I Boston Scientific Corporation
Nov 17, 2020 Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on ... Failure to execute the visual inspection correctly prior to locking the valve during the deployme... Class I Boston Scientific Corporation
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 13, 2020 EMBLEM S-ICD Subcutaneous Electrode Model 3501. Component of implantable car... There is potential for fractures which results in the inability to delivery therapy. Class I Boston Scientific Corporation
Nov 12, 2020 Life2000 Ventilation System, including Life2000 Ventilator and Life2000 Compr... Under certain conditions, there is a risk for fire. Class II Hill-Rom Manufacturing, Inc.
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 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 Titan Pump - Product Usage: indicated for male patients suffering from erecti... Potential increased occurrence of pump fracture over the lifetime of the device. Class II Coloplast Manufacturing US, LLC

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.