Browse Device Recalls

603 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 603 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 603 FDA device recalls.

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DateProductReasonClassFirm
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
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 16, 2020 Contour VL Variable Length Ureteral Stent, UPN M0061801550, M0061801560, M006... Trace amounts of metallic debris were found on the stent related to the manufacturing process. Th... Class II Boston Scientific Corporation
Nov 16, 2020 Contour VL Variable Length Ureteral Stent Set, UPN M006180155090, M0061801560... Trace amounts of metallic debris were found on the stent related to the manufacturing process. Th... Class II Boston Scientific Corporation
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 3, 2020 EKOS Control System (CU) 4.0. UPN 600-40500 The EkoSonic MACH4 Endovascu... This is a follow-up to the EKOS Field Safety Notice dated April 30, 2019. The Radio Frequency (RF... Class II Boston Scientific Corporation
Sep 24, 2020 AMS 700 MS Pump with and without InhibiZone, sold as individual units and als... The recalling firm has observed an increase in complaints of problems encountered during the init... Class II 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.