Browse Device Recalls

638 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 638 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 638 FDA device recalls.

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DateProductReasonClassFirm
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
Sep 22, 2020 Visual-ICE MRI Cryoablation System Mobile Connection Panel (Visual-ICE MRI MC... Incorrectly installed base. Class II Boston Scientific Corporation
Sep 22, 2020 Model 3300 LATITUDE Programming System with installed Model 3892 ALTRUA, INSI... There is potential when a user changes an EGM trace channel with a Manual Pace Threshold test in ... Class II Boston Scientific Corporation
Sep 16, 2020 Hurricane RX Biliary Balloon Dilatation Catheter Catalog REF No. M00545890; ... RX tunnel component (black sheath) may detach from the catheter shaft due to lower bond strength. Class II Boston Scientific Corporation
Aug 24, 2020 Opticross 35 15 MHz Peripheral Imaging Catheter 8F (2.74 mm) X 105 cm Expirat... Opticross 35 Peripheral Imaging Catheter is being recalled because the incremental telescoping le... Class II Boston Scientific Corporation
Aug 7, 2020 WallFlexTM Biliary RX Fully Covered Stent System RMV (10mmx60mm Stent) UPN: M... Mislabeled: WallFlex Biliary RX Uncovered Stent System 10x60mm devices labeled as WallFlexTM Bil... Class II Boston Scientific Corporation
Jul 6, 2020 Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flex... BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential c... Class II Boston Scientific Corporation
Jul 6, 2020 Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flex... BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential c... Class II Boston Scientific Corporation
Jul 6, 2020 Captiflex Snares, Single-Use Polypectomy Snare consists of a flexible wire ca... BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential c... Class II Boston Scientific Corporation
Jul 6, 2020 Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flex... BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential c... Class II Boston Scientific Corporation
Jul 6, 2020 Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flex... BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential c... Class II Boston Scientific Corporation
Jul 6, 2020 Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flex... BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential c... Class II Boston Scientific Corporation
Jul 6, 2020 Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flex... BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential c... Class II Boston Scientific Corporation
Jun 4, 2020 Ablation Galil Technology, IceFORCE 2.1 CX Needle Cryoablation Needle, Prescr... The needle surface deteriorated due to unexpected electrolysis during procedure. Class II Boston Scientific Corporation
Jun 4, 2020 Ablation Galil Technology, Three IceFORCE 2.1 Prostate Cyroablation Kit Visu... The needle surface deteriorated due to unexpected electrolysis during procedure. Class II Boston Scientific Corporation
Jun 4, 2020 Ablation Galil Technology, IcePearl 2.1 CX 90 Cyroablation Needles, Prescript... The needle surface deteriorated due to unexpected electrolysis during procedure. 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.