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.

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Date	Product	Reason	Class	Firm
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
Jun 4, 2020	Ablation Galil Technology, IcePearl 2.0 CX 90 Cryoablation Needle, Prescripti...	The needle surface deteriorated due to unexpected electrolysis during procedure.	Class II	Boston Scientific Corporation
Jun 4, 2020	Ablation Galil Technology, IceFORCE 2.1 CX Prostate Kit Visual ICE System, Pr...	The needle surface deteriorated due to unexpected electrolysis during procedure.	Class II	Boston Scientific Corporation
Jun 4, 2020	Ablation Galil Technology, IceForce 2.1 CX 90 Cyroablation Needles, Prescript...	The needle surface deteriorated due to unexpected electrolysis during procedure.	Class II	Boston Scientific Corporation
Jun 4, 2020	Ablation Galil Technology, IceFORCE 2.1 CX 90 Needle Cryoablation Needle, Pre...	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 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 CX Prostate Cyroablation Kit V...	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 Prostate¿Kit Visual Ice System, Pr...	The needle surface deteriorated due to unexpected electrolysis during procedure.	Class II	Boston Scientific Corporation
Mar 30, 2020	MoXy Laser Fiber, Material Number 0010-2400 - Product Usage: The fiber can be...	To reinforce existing instructions within the Directions for Use (DFU) and provide further guidan...	Class II	Boston Scientific Corporation
Mar 9, 2020	Percuflex Plus Ureteral Stent Set 7FX24CM with .035 Sensor UPN: M00617527208...	An increase in the rate of complaints for difficulty or inability to track over the guidewire, ma...	Class II	Boston Scientific
Mar 9, 2020	Percuflex Plus Ureteral Stent Set 6FX24CM with .038 Sensor UPN: M00617526...	An increase in the rate of complaints for difficulty or inability to track over the guidewire, ma...	Class II	Boston Scientific
Mar 9, 2020	Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX STR/150CM UPN: M00667...	An increase in the rate of complaints for difficulty or inability to track over the guidewire, ma...	Class II	Boston Scientific
Mar 9, 2020	Stretch VL Ureteral Stent Set 7FX22-30CM with .035 Sensor UPN: M006185157080	An increase in the rate of complaints for difficulty or inability to track over the guidewire, ma...	Class II	Boston Scientific
Mar 9, 2020	Stretch VL Ureteral Stent Set 4.8FX22-30CM with .035 Sensor UPN: M006185155080	An increase in the rate of complaints for difficulty or inability to track over the guidewire, ma...	Class II	Boston Scientific
Mar 9, 2020	Contour VL Ureteral Stent Set 6FX22-30CM with .035 Sensor UPN: M006180156080	An increase in the rate of complaints for difficulty or inability to track over the guidewire, ma...	Class II	Boston Scientific
Mar 9, 2020	Sensor Nitinol Wire with Hydrophilic Tip .038 3CM FLEX STR/150CM UPN: M00...	An increase in the rate of complaints for difficulty or inability to track over the guidewire, ma...	Class II	Boston Scientific
Mar 9, 2020	Stretch VL Ureteral Stent Set 6FX22- 30CM with .035 Sensor UPN: M006185156080	An increase in the rate of complaints for difficulty or inability to track over the guidewire, ma...	Class II	Boston Scientific
Mar 9, 2020	Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX /150CM UPN: M00667030...	An increase in the rate of complaints for difficulty or inability to track over the guidewire, ma...	Class II	Boston Scientific
Mar 9, 2020	Sensor Nitinol Wire with Hydrophilic Tip .0383CM FLEX ANG/150CM UPN: M006...	An increase in the rate of complaints for difficulty or inability to track over the guidewire, ma...	Class II	Boston Scientific
Mar 9, 2020	Polaris Ultra Ureteral Stent Set 6FX24CM with .035 Sensor UPN: M006192132080	An increase in the rate of complaints for difficulty or inability to track over the guidewire, ma...	Class II	Boston Scientific
Mar 9, 2020	Percuflex Plus Ureteral Stent Set 6FX26CM with .038 Sensor UPN: M006175263110	An increase in the rate of complaints for difficulty or inability to track over the guidewire, ma...	Class II	Boston Scientific
Feb 12, 2020	Boston Scientific, Implantable Cardioverter Defibrillator, DYNAGEN EL ICD DR,...	Boston Scientific released a new Software Update Application that was downloaded to four (4) dist...	Class II	Boston Scientific Corporation
Feb 12, 2020	Boston Scientific, LATITUDE Programming System, Model 3300 - Product Usage:Th...	Boston Scientific released a new Software Update Application that was downloaded to four (4) dist...	Class II	Boston Scientific Corporation
Feb 11, 2020	Imager II 5F Angiographic Catheters, 5 units per package.	Potential for tip detachment of Imager II 5F Angiographic Catheters	Class I	Boston Scientific Corporation
Dec 17, 2019	AMS 700 100 mL, Spherical Reservoir with InhibiZone, Part No. 72404156 - Prod...	A labeling discrepancy incorrectly labeled AMS 700 100mL Conceal Low Profile Reservoir with Inhib...	Class II	Boston Scientific Corporation
Nov 18, 2019	Habib EUS RFA, 20mm electrode active tip, Material Number/UPN: 6700 - Product...	During testing on the Habib EUS RFA device, a temperature increase was observed at the tip of the...	Class II	Boston Scientific Corporation
Nov 18, 2019	Habib EUS RFA, 10mm electrode active tip, Material Number/UPN: 6500 - Product...	During testing on the Habib EUS RFA device, a temperature increase was observed at the tip of the...	Class II	Boston Scientific Corporation
Nov 8, 2019	AngioJet Ultra Consoles-Thrombectomy System UPN: 105650-001D 105650-001H ...	Missing Directions for Use (DFU) - Consoles shipped to customers without the required Operator's ...	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.