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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.