Browse Device Recalls
681 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 681 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 681 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 2, 2020 | EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System;... | Accelerated battery depletion may result in a need for device replacement earlier than expected. | Class II | Boston Scientific Corporation |
| Dec 2, 2020 | EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Mod... | Accelerated battery depletion may result in a need for device replacement earlier than expected. | Class II | Boston Scientific Corporation |
| Dec 2, 2020 | EMBLEM MRI S-ICD Model A219 | Electrical overstress may lead to device malfunction. | Class I | Boston Scientific Corporation |
| Dec 2, 2020 | EMBLEM S-ICD Model A209 | Electrical overstress may lead to device malfunction. | Class I | Boston Scientific Corporation |
| Dec 1, 2020 | AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x15mm UPN: M00... | The rotating luer fitting at the distal end of the delivery system handle may become detached fr... | Class II | Boston Scientific Corporation |
| Dec 1, 2020 | Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x10mm (OUS... | The rotating luer fitting at the distal end of the delivery system handle may become detached fr... | Class II | Boston Scientific Corporation |
| Dec 1, 2020 | AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x10mm UPN: M00... | The rotating luer fitting at the distal end of the delivery system handle may become detached fr... | Class II | Boston Scientific Corporation |
| Dec 1, 2020 | Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x15mm (OUS... | The rotating luer fitting at the distal end of the delivery system handle may become detached fr... | Class II | Boston Scientific Corporation |
| Dec 1, 2020 | AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm UPN: M00... | The rotating luer fitting at the distal end of the delivery system handle may become detached fr... | Class II | Boston Scientific Corporation |
| Dec 1, 2020 | Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm (OUS... | The rotating luer fitting at the distal end of the delivery system handle may become detached fr... | 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 | 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 |
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.