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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DateProductReasonClassFirm
Mar 18, 2016 Boston Scientific Ultraflex Tracheobronchial Distal Release Stent System 12mm... Mislabeled: 10mm diameter x 30mm length Ultraflex Tracheobronchial stents were labeled as 12mm di... Class II Boston Scientific Corporation
Mar 15, 2016 Boston Scientific TSX Transseptal Needle, Model Number M004TSX60o; Used to c... Merit Medical Systems, Inc. is voluntarily conducting a recall of one lot of the TSX" Transseptal... Class II Merit Medical Systems, Inc.
Dec 10, 2015 Boston Scientific, PROPONENT" MRI DR Pacemakers, REF L211. These devices ... The literature packet packaged with the devices incorrectly describes the pacemaker as SR when it... Class II Boston Scientific Corporation
Dec 10, 2015 Boston Scientific, MRI PROPONENT" SR , REF L210 Pacemaker. These devices t... The literature packet packaged with the devices incorrectly describes the pacemaker as SR when it... Class II Boston Scientific Corporation
Nov 25, 2015 Boston Scientific ACUITY Pro Coronary Sinus Guide Catheter, 9 Fr. Model 8104... Potential for separation of the proximal handle from the shaft. Class II Boston Scientific Corporation
Nov 20, 2015 IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-10 OUS; Material Numbe... During routine monitoring of complaints, BSC noted that the IntellaTip MiFi XP N4 complaint rate ... Class II Boston Scientific Corp
Nov 20, 2015 IntellaTip MiFi XP Asymmetric (N4) Curve, 7/110/2.5/8-8 OUS; Material Numbe... During routine monitoring of complaints, BSC noted that the IntellaTip MiFi XP N4 complaint rate ... Class II Boston Scientific Corp
Nov 20, 2015 IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-10 ; Material Number: ... During routine monitoring of complaints, BSC noted that the IntellaTip MiFi XP N4 complaint rate ... Class II Boston Scientific Corp
Nov 20, 2015 IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-8 Material Number: M00... During routine monitoring of complaints, BSC noted that the IntellaTip MiFi XP N4 complaint rate ... Class II Boston Scientific Corp
Nov 19, 2015 Boston Scientific, Chariot ST-CCV Guiding Sheath, Sterilized using ethylene o... Boston Scientific is voluntarily recalling its Chariot" Guiding Sheath. To date, Boston Scientifi... Class I Boston Scientific Corporation
Oct 9, 2015 RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Dev... Boston Scientific is recalling its recently released RotaWire Elite Guidewire and wireClip Torque... Class I Boston Scientific Corporation
Oct 9, 2015 RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Dev... Boston Scientific is recalling its recently released RotaWire Elite Guidewire and wireClip Torque... Class I Boston Scientific Corporation
Sep 17, 2015 Boston Scientific SQ-RX Model 1010 subcutaneous pulse generator, (S-ICD). ... Devices shipped to US in dual-channel rather than US approved single-channel RF Telemetry communi... Class II Boston Scientific Corporation
Sep 11, 2015 One Step Button, Low Profile Initial Placement PEG Kit, gastro-enterostomy tube. Boston Scientific Corp. initiated a voluntary recall of specific lots of the EndoVive One Step Bu... Class II Boston Scientific Corp
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
Feb 11, 2015 Medical Device Exchange PT WIRE 300; Pouch, Tyvek/Mylar, Sterile, Single Us... EXP did not register as a medical device establishment, list the devices being recalled, or esta... Class II EXP Pharmaceutical Services Corp
Feb 3, 2015 IntellaTip MiFi Open-Irrigated radiofrequency Ablation Catheters: Material n... Reports of formation of char adherent to the proximal part of the distal tip electrodes Class I Boston Scientific Corp
Nov 20, 2014 IntellaMap Orion High Resolution Mapping Catheter; Material number: M004RC64... Some IntellaMap Orion High Resolution Mapping Catheters are exhibiting a failure mode in which a ... Class II Boston Scientific Corp
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
Sep 17, 2014 Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E11... Boston Scientific identified a subset of COGNISTM CRT-Ds and TELIGENTM ICDs that had experienced ... Class II Boston Scientific CRM Corp
Sep 17, 2014 Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillat... Boston Scientific identified a subset of COGNISTM CRT-Ds and TELIGENTM ICDs that had experienced ... Class II Boston Scientific CRM Corp
Jun 19, 2014 Boston Scientific ENDOTAK RELIANCE¿ SG, transvenous defibrillation lead, Mode... A review of manufacturing test records for Boston Scientific ENDOTAK RELIANCE implantable leads ... Class II Boston Scientific CRM Corp
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 31, 2014 Boston Scientific, NovaGold High Performance Guidewire, Rx only, Sterilized u... Neo Metrics, Inc. is recalling NovaGold Guidewire because the tip may uncoil and / detach more fr... Class II NEO METRICS, INC.
Mar 11, 2014 Teleflex Medical, Research Triangle Park, NC, Braided Polyester Rx Only, Ste... Product does not meet minimum needle attachment strength requirements; thus, the needle can becom... Class II Teleflex Medical
Mar 11, 2014 Teleflex Medical, Research Triangle Park, NC, Polypropylene, Rx Only, Steril... Product does not meet minimum needle attachment strength requirements; thus, the needle can becom... Class II Teleflex Medical
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

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.