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
Aug 25, 2015 Boston Scientific, WATCHMAN Access System Access Sheath with Dilator, 14F S... Cross-threading of the hemostasis valve may occur if it is tightened with the dilator in place, p... Class II Boston Scientific Corporation
Aug 25, 2015 Boston Scientific, WATCHMAN Left Atrial Appendage Closure Device with Deliver... Cross-threading of the hemostasis valve may occur if it is tightened with the dilator in place, p... Class II Boston Scientific Corporation
Jul 31, 2015 AngioJet Spiroflex Thrombectomy Set: Peripheral - UPN 106553-004, Catalog No.... AngioJet products were distributed with an incorrect use-by (expiry) date. The correct date is N... Class II Boston Scientific Corporation
Jul 31, 2015 AngioJet AVX Thrombectomy Set: UPN 105039-001, Catalog No.105039, Sterilized ... AngioJet products were distributed with an incorrect use-by (expiry) date. The correct date is N... Class II Boston Scientific Corporation
Jul 31, 2015 AngioJet SOLENT Omni Thrombectomy Set: UPN 109681-004 & 109681-001, Catalog N... AngioJet products were distributed with an incorrect use-by (expiry) date. The correct date is N... Class II Boston Scientific Corporation
Jul 31, 2015 AngioJet SOLENT Dista Thrombectomy Set: UPN 111303-001, Catalog No. 111303, S... AngioJet products were distributed with an incorrect use-by (expiry) date. The correct date is N... Class II Boston Scientific Corporation
Jun 2, 2015 CLEARSIGN II Amplifier for LABSYSTEM PRO EP Recording System, 120 channels, ... Boston Scientific has received complaints indicating that, when using the blood pressure (BP) cha... Class II Boston Scientific Corporation
Apr 27, 2015 Extractor Pro RX Retrieval Balloon Catheter 9-12 mm Above Retrieval Balloon C... One lot of the Extractor" Pro RX Retrieval Balloon Catheter (9-12mm balloon) contains an incorrec... Class II Boston Scientific Corporation
Feb 25, 2015 Boston Scientific: Expel" Drainage Catheter with Twist-Loc" Hub APDL Drainag... Boston Scientific is initiating this Medical Device Field Correction of the Expel" APD and APDL ... Class II Boston Scientific Corporation
Feb 25, 2015 Various Lots of Expel Drainage Catheter with TwistLoc Hub Biliary Drainage Ca... Complaints of device fragmentation after the catheter was implanted in the biliary system. The mo... Class II Boston Scientific Corporation
Nov 19, 2014 Lotus TAVR 27mm, Transcatheter Aortic Valve Prosthesis Premounted on Delive... Lotus valve became unlocked during release from the delivery system. This may lead to percutaneo... Class I Boston Scientific Corporation
Nov 19, 2014 Lotus TAVR 25mm, Transcatheter Aortic Valve Prosthesis Premounted on Delive... Lotus valve became unlocked during release from the delivery system. This may lead to percutaneo... Class I Boston Scientific Corporation
Nov 19, 2014 Lotus TAVR 23mm, Transcatheter Aortic Valve Prosthesis Premounted on Delive... Lotus valve became unlocked during release from the delivery system. This may lead to percutaneo... Class I Boston Scientific Corporation
Sep 30, 2014 StarMedTec LightTrail¿ Reusable Fibers, 800 um; Material/Part Number: 6457 Product is not cleared for use with lasers other than the Auriga XL system Class II Boston Scientific Corporation
Sep 30, 2014 StarMedTec LightTrail¿ Reusable Fibers, 365 um; Material/Part Number: 6453 Product is not cleared for use with lasers other than the Auriga XL system Class II Boston Scientific Corporation
Sep 30, 2014 StarMedTec LightTrail¿ Reusable Fibers, 600 um; Material/Part Number: 6455 Product is not cleared for use with lasers other than the Auriga XL system Class II Boston Scientific Corporation
May 15, 2014 IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Large Cur... Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according ... Class II Boston Scientific Corporation
May 15, 2014 IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm); Asymmetr... Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according ... Class II Boston Scientific Corporation
May 15, 2014 IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm) Standard ... Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according ... Class II Boston Scientific Corporation
May 15, 2014 IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Asymmetri... Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according ... Class II Boston Scientific Corporation
May 15, 2014 IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Standard ... Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according ... Class II Boston Scientific Corporation
May 15, 2014 IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm); Large Cu... Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according ... Class II Boston Scientific Corporation
Apr 3, 2014 iLab Ultrasound Imaging System; iLab 3.0 (Polaris 1.0) software. Used for ul... Specific iLab Ultrasound Imaging Systems using newest 3.0 (Polaris 1.0) software change the pullb... Class II Boston Scientific Corporation
Mar 3, 2014 Boston Scientific, RunWay Guide Catheter, UPN H749389696640, Catalog Number 3... The sterile pouch of the devices from this lot may not be completely sealed and sterility may be ... Class II Boston Scientific Corporation
Feb 4, 2014 Boston Scientific, Coyote" MONORAIL" PTA Balloon Dilatation Catheter, UPN # H... Boston Scientific is initiating this Recall Removal of one lot of the Coyote" OVER-THE-WIRE PTA B... Class II Boston Scientific Corporation
Feb 4, 2014 Boston Scientific, 2.5mm Coyote" OVER-THE-WIRE PTA Balloon Dilation Catheter,... Boston Scientific is initiating this Recall Removal of one lot of the Coyote" OVER-THE-WIRE PTA B... Class II Boston Scientific Corporation
Jan 6, 2014 Atlantis PV, 8.5F, 15 MHz Peripheral Imaging Catheter: Sterile, R; Steriliz... Reports of physicians experiencing inability to pass a 0.035" guidewire through the guidewire lum... Class II Boston Scientific Corporation
Dec 18, 2013 Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 12-15 mm Inject... Extractor Pro XL Retrieval Balloon Catheters may have the incorrect skive hole location or balloo... Class II Boston Scientific Corporation
Dec 18, 2013 Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 12-15 mm Injec... Extractor Pro XL Retrieval Balloon Catheters may have the incorrect skive hole location or balloo... Class II Boston Scientific Corporation
Dec 18, 2013 Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 9-12 mm Injects... Extractor Pro XL Retrieval Balloon Catheters may have the incorrect skive hole location or balloo... Class II Boston Scientific Corporation
Nov 20, 2013 TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 5 configuration) Univ... Sterility of device may be compromised due to lack of pouch seal integrity Class II Boston Scientific Corporation
Nov 20, 2013 TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 10 configuration) Unive... Sterility of device may be compromised due to lack of pouch seal integrity Class II Boston Scientific Corporation
Nov 20, 2013 TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 1 configuration) Univ... Sterility of device may be compromised due to lack of pouch seal integrity Class II Boston Scientific Corporation
Nov 20, 2013 TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 5 configuration) Unive... Sterility of device may be compromised due to lack of pouch seal integrity Class II Boston Scientific Corporation
Nov 20, 2013 TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 10 configuration) Inte... Sterility of device may be compromised due to lack of pouch seal integrity Class II Boston Scientific Corporation
Nov 20, 2013 TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 1 configuration) Univ... Sterility of device may be compromised due to lack of pouch seal integrity Class II Boston Scientific Corporation
Nov 5, 2013 Navigator HD l3F/15F x 28 cm Ureteral Access Sheath Set Product No M00625022... The 13F/15F Navigator HD Ureteral Access SheathSet are being recalled after receipt of 5 reports ... Class II Boston Scientific Corporation
Nov 5, 2013 Navigator HD l3F/15F x 36cm Ureteral Access Sheath Set Product No M006250228... The 13F/15F Navigator HD Ureteral Access SheathSet are being recalled after receipt of 5 reports ... Class II Boston Scientific Corporation
Nov 5, 2013 Navigator HD l3F/15F x 46cm Ureteral Access Sheath Set Product No M006250228... The 13F/15F Navigator HD Ureteral Access SheathSet are being recalled after receipt of 5 reports ... Class II Boston Scientific Corporation
Jul 31, 2013 Boston Scientific, FlextomeTM Cutting BalloonTM, Sterilized using irradiatio... Boston Scientific is initiating a recall removal of the 4.0mm x 15mm size of Small Peripheral Cut... Class II Boston Scientific Corporation
Jul 31, 2013 Boston Scientific, Small Peripheral Cutting BalloonTM, Sterilized using irrad... Boston Scientific is initiating a recall removal of the 4.0mm x 15mm size of Small Peripheral Cut... Class II Boston Scientific Corporation
Jun 24, 2013 Stryker brand Neuroform 3 Microdelivery Stent System, 4.5 mm X 20 mm, REF Cat... The device is labeled incorrectly, in that, the device Model Number on the outer carton and inner... Class II Stryker Neurovascular
May 28, 2013 NephroMax high Pressure Nephrostomy Balloon Catheter. Material Number/Catalog... Incorrect sized renal sheath was packaged with the NephroMax high pressure nephrostomy Balloon Ca... Class II Boston Scientific Corporation
May 28, 2013 Alair Bronchial Thermoplasty Catheter, Bronchial Thermoplasty System; Materia... Boston Scientific has discovered an inconsistent "Use By" expiration date on a single lot/batch o... Class II Boston Scientific Corporation
May 28, 2013 NephroMax high Pressure nephrostomy Balloon Catheter Kit. Material Number/Ca... Incorrect sized renal sheath was packaged with the NephroMax high pressure nephrostomy Balloon Ca... Class II Boston Scientific Corporation
May 28, 2013 RigiflexTM 11 Single-Use Achalasia Balloon Dilator, Material Number (UPN) M00... Product labeled with incorrect expiration date. Class III Boston Scientific Corporation
Sep 17, 2012 Leveen Coaccess Needle Electrode (3.5/15) and (4.0/15). Disposable, mono... Leveen Standard and Leveen Coaccess Needle Electrode System, Directions for Use(DFU) in Portugue... Class II Boston Scientific Corporation
Sep 17, 2012 LeVeen Standard Needle Electrode System, Sterile (3.5/12), (3.5/15), (4.0/15)... Leveen Standard and Leveen Coaccess Needle Electrode System, Directions for Use(DFU) in Portugue... Class II Boston Scientific Corporation
Sep 17, 2012 Leveen Coaccess Introducer Set. Disposable, monopolar, electrosurgical dev... Leveen Standard and Leveen Coaccess Needle Electrode System, Directions for Use(DFU) in Portugue... Class II Boston Scientific Corporation
Sep 6, 2012 Boston Scientific, Z Flex 270, Steerable Sheath, Sterile EO, Rx only, Distri... During the investigation of four returned Z Flex 270 Steerable Sheaths that were used with cardia... Class II Greatbatch Medical

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.