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Is Boston Scientific recalled?

Boston Scientific recalls - full list & free alerts

Official U.S. agency records list 82 recalls involving Boston Scientific in the last 12 months, most recently on 2026-09-30. Check each official notice for the exact products, lot codes and dates affected.

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Recalls (82)

Boston Scientific Corporation: Imager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5; M001314011 IMAGER II/5/ST/100/038 BX5; M001314021 IMAGER
Medical DevicesFDA (device) · 2026-09-30 · Class I
Boston Scientific Corporation: Boston Scientific Corporation StoneSmart Connect Console Contents: (1) Power Cord, (1) Power Adaptor, (1)DVI Cable, (1) DVI to HDMI Cable,
Medical DevicesFDA (device) · 2026-09-23 · Class II
Boston Scientific Corporation: LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS US, Model Number 7260, All Versions (Current 7.8)
Medical DevicesFDA (device) · 2026-09-09 · Class II
Boston Scientific Corporation: LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS EU, Model Number 7246, All Versions (Current 7.7)
Medical DevicesFDA (device) · 2026-09-09 · Class II
Boston Scientific Corporation: LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS ANZ, Model Number 7248, All Versions (Current 7.7)
Medical DevicesFDA (device) · 2026-09-09 · Class II
Boston Scientific Corporation: OverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device.
Medical DevicesFDA (device) · 2026-08-26 · Class II
Boston Scientific Corporation: Suture Cinch Long 1pk. Endoscopic tissue approximation device.
Medical DevicesFDA (device) · 2026-08-26 · Class II
Boston Scientific Corporation: Boston Scientific ENROUTE Transcarotid Neuroprotection System, Material Number SR-200-NPS; Percutaneous catheter
Medical DevicesFDA (device) · 2026-08-26 · Class I
Boston Scientific Corporation: Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus, Material Number SR-250-NPS; Percutaneous catheter
Medical DevicesFDA (device) · 2026-08-26 · Class I
Boston Scientific Corporation: Radial Jaw 4 Standard Capacity Biopsy Forceps with the following descriptions and UPN: 1. Radial Jaw 4 SC 240cm Box 20; Outer Box UPN:
Medical DevicesFDA (device) · 2026-08-12 · Class II
Boston Scientific Corporation: Radial Jaw 4 Large Capacity Biopsy Forceps with the following descriptions and UPN: 1. Radial Jaw 4 LC 240cm Box 20; Outer Box UPN: M00
Medical DevicesFDA (device) · 2026-08-12 · Class II
Boston Scientific Corporation: Radial Jaw 4 Jumbo Biopsy Forceps with the following descriptions and UPN: Radial Jaw 4 Jumbo 240cm Box 5; Outer Box UPN: M00513363;
Medical DevicesFDA (device) · 2026-08-12 · Class II
Boston Scientific Corporation: FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter
Medical DevicesFDA (device) · 2026-07-29 · Class II
Boston Scientific Corporation: FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401; Percutaneous Cardiac Ablation Catheter
Medical DevicesFDA (device) · 2026-07-29 · Class II
Boston Scientific Corporation: FARASTAR PFA Generator, Product ID M004PFCE61M460; Percutaneous Cardiac Ablation Catheter
Medical DevicesFDA (device) · 2026-07-29 · Class II
Boston Scientific Corporation: FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter
Medical DevicesFDA (device) · 2026-07-29 · Class II
Boston Scientific Corporation: FARADRIVE Steerable Sheath Clear IDE, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21C60
Medical DevicesFDA (device) · 2026-07-29 · Class II
Boston Scientific Corporation: FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21M402, I
Medical DevicesFDA (device) · 2026-07-29 · Class II
Boston Scientific Corporation: FARADRIVE STEERABLE SHEATH (CLEAR) - US, used to facilitate access to the vasculature and into the chambers of the heart, Material Number M0
Medical DevicesFDA (device) · 2026-07-29 · Class II
Boston Scientific Corporation: FARADRIVE STEERABLE SHEATH CLEAR OUS, used to facilitate access to the vasculature and into the chambers of the heart, Material Number M004P
Medical DevicesFDA (device) · 2026-07-29 · Class II
Boston Scientific Corporation: Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001; Radiological Image Processing System.
Medical DevicesFDA (device) · 2026-07-29 · Class II
Boston Scientific Corporation: Rapid Refill Continuous Injection System, UPN M00566001
Medical DevicesFDA (device) · 2026-07-22 · Class II
Boston Scientific Corporation: CRE Pro Wireguided 6-8mm 240cm
Medical DevicesFDA (device) · 2026-07-08 · Class II
Boston Scientific Corporation: CRE Pro Wireguided 8-10mm 240cm
Medical DevicesFDA (device) · 2026-07-08 · Class II
Boston Scientific Corporation: CRE Pro Wireguided 10-12mm 240cm
Medical DevicesFDA (device) · 2026-07-08 · Class II
Boston Scientific Corporation: CRE Pro Wireguided 12-15mm 240cm
Medical DevicesFDA (device) · 2026-07-08 · Class II
Boston Scientific Corporation: CRE Pro Wireguided 15-18mm 240cm
Medical DevicesFDA (device) · 2026-07-08 · Class II
Boston Scientific Corporation: CRE Pro Wireguided 18-20mm 240cm
Medical DevicesFDA (device) · 2026-07-08 · Class II
Boston Scientific Corporation: CRE Wireguided 6-8mm 240cm
Medical DevicesFDA (device) · 2026-07-08 · Class II
Boston Scientific Corporation: CRE Wireguided 8-10mm 240cm
Medical DevicesFDA (device) · 2026-07-08 · Class II
Boston Scientific Corporation: CRE Wireguided 10-12mm 240cm
Medical DevicesFDA (device) · 2026-07-08 · Class II
Boston Scientific Corporation: CRE Wireguided 12-15mm 240cm
Medical DevicesFDA (device) · 2026-07-08 · Class II
Boston Scientific Corporation: CRE Wireguided 15-18mm 240cm
Medical DevicesFDA (device) · 2026-07-08 · Class II
Boston Scientific Corporation: CRE Wireguided 18-20mm 240cm
Medical DevicesFDA (device) · 2026-07-08 · Class II
Boston Scientific Corporation: Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable drug delivery device
Medical DevicesFDA (device) · 2026-07-01 · Class II
Boston Scientific Corporation: Orca Single Use Air/Water and Suction Valves, Material Number (UPN) SUV-617-50; The Orca Air/Water Valve is intended to be used to control t
Medical DevicesFDA (device) · 2026-06-17 · Class II
Boston Scientific Corporation: LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5
Medical DevicesFDA (device) · 2026-05-13 · Class II
Boston Scientific Corporation: LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATITUDE DRAGON EU (Europe), Model 6446, Version 7.5, or SERVER SW
Medical DevicesFDA (device) · 2026-05-13 · Class II
Boston Scientific Corporation: Boston Scientific Pacemaker, Implantable Pulse Generator, Pacemaker (non- Cardiac Re-Synchronization Therapy) labeled as: 1. ESSENTIO SR
Medical DevicesFDA (device) · 2026-05-06 · Class I
Boston Scientific Corporation: Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VALITUDE CRT-P EL, Model Number U125; 2. VALITUDE CRT-P EL MRI,
Medical DevicesFDA (device) · 2026-05-06 · Class I
Boston Scientific Corporation: EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner Box Material Number (UPN): M00509000;
Medical DevicesFDA (device) · 2026-03-18 · Class II
Boston Scientific Corporation: AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm; Material Number (UPN): M00553660;
Medical DevicesFDA (device) · 2026-02-11 · Class I
Boston Scientific Corporation: AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm; Material Number (UPN): M00553680;
Medical DevicesFDA (device) · 2026-02-11 · Class I
Boston Scientific Corporation: AXIOS Stent and Electrocautery-Enhanced Delivery System - 8mm x 8mm; Material Number (UPN): M00553690;
Medical DevicesFDA (device) · 2026-02-11 · Class I
Boston Scientific Corporation: HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm; Material Number (UPN): M00553520;
Medical DevicesFDA (device) · 2026-02-11 · Class I
Boston Scientific Corporation: *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mm x 8mm; Material Number (UPN): M00553530;
Medical DevicesFDA (device) · 2026-02-11 · Class I
Boston Scientific Corporation: *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm; Material Number (UPN): M00553560;
Medical DevicesFDA (device) · 2026-02-11 · Class I
Boston Scientific Corporation: Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F, 1) 2.5mm x120mm, 150 cm, UPM/Model No. REF H74939186251210; 2)
Medical DevicesFDA (device) · 2026-01-21 · Class II
Boston Scientific Corporation: ACCOLADE SR SL (Model L300)
Medical DevicesFDA (device) · 2025-10-22 · Class I
Boston Scientific Corporation: ACCOLADE DR SL (Model L301)
Medical DevicesFDA (device) · 2025-10-22 · Class I
Boston Scientific Corporation: ACCOLADE SR SL MRI (Model L310)
Medical DevicesFDA (device) · 2025-10-22 · Class I
Boston Scientific Corporation: ACCOLADE DR SL MRI (Model L311)
Medical DevicesFDA (device) · 2025-10-22 · Class I
Boston Scientific Corporation: ACCOLADE DR EL (Model L321)
Medical DevicesFDA (device) · 2025-10-22 · Class I
Boston Scientific Corporation: ACCOLADE DR EL MRI (Model L331)
Medical DevicesFDA (device) · 2025-10-22 · Class I
Boston Scientific Corporation: PROPONENT SR SL (Model L200)
Medical DevicesFDA (device) · 2025-10-22 · Class I
Boston Scientific Corporation: PROPONENT DR SL (Model L201)
Medical DevicesFDA (device) · 2025-10-22 · Class I
Boston Scientific Corporation: Model Number L209 PROPONENT DR (VDD) SL Pacemaker
Medical DevicesFDA (device) · 2025-10-22 · Class I
Boston Scientific Corporation: Model Number L210 PROPONENT SR SL Pacemaker
Medical DevicesFDA (device) · 2025-10-22 · Class I
Boston Scientific Corporation: Model Number L211 PROPONENT DR SL MRI Pacemaker
Medical DevicesFDA (device) · 2025-10-22 · Class I
Boston Scientific Corporation: Model Number L221 PROPONENT DR EL Pacemaker
Medical DevicesFDA (device) · 2025-10-22 · Class I
Boston Scientific Corporation: Model Number L231, PROPONENT DR EL MRI Pacemaker
Medical DevicesFDA (device) · 2025-10-22 · Class I
Boston Scientific Corporation: Model Number L100, ESSENTIO SR SL Pacemaker
Medical DevicesFDA (device) · 2025-10-22 · Class I
Boston Scientific Corporation: Model Number L101, ESSENTIO DR SL Pacemaker
Medical DevicesFDA (device) · 2025-10-22 · Class I
Boston Scientific Corporation: Model Number L110, ESSENTIO SR SL MRI Pacemaker
Medical DevicesFDA (device) · 2025-10-22 · Class I
Boston Scientific Corporation: Model Number L111, ESSENTIO DR SL MRI Pacemaker
Medical DevicesFDA (device) · 2025-10-22 · Class I
Boston Scientific Corporation: Model Number L121 ESSENTIO DR EL Pacemaker
Medical DevicesFDA (device) · 2025-10-22 · Class I
Boston Scientific Corporation: Model Number L131, ESSENTIO DR EL MRI Pacemaker
Medical DevicesFDA (device) · 2025-10-22 · Class I
Boston Scientific Corporation: Model Number S701 ALTRUA 2 SR SL Pacemaker
Medical DevicesFDA (device) · 2025-10-22 · Class I
Boston Scientific Corporation: Model Number S702, ALTRUA 2 DR SL Pacemaker
Medical DevicesFDA (device) · 2025-10-22 · Class I
Boston Scientific Corporation: Model Number S722, ALTRUA 2 DR EL Pacemaker
Medical DevicesFDA (device) · 2025-10-22 · Class I
Boston Scientific Corporation: Model Number U125, VALITUDE CRT-P EL
Medical DevicesFDA (device) · 2025-10-22 · Class I
Boston Scientific Corporation: Model Number U128, VALITUDE CRT-P EL MRI
Medical DevicesFDA (device) · 2025-10-22 · Class I
Boston Scientific Corporation: Model Number U225 VISIONIST CRT-P EL
Medical DevicesFDA (device) · 2025-10-22 · Class I
Boston Scientific Corporation: Model Number U226, VISIONIST CRT-P EL
Medical DevicesFDA (device) · 2025-10-22 · Class I
Boston Scientific Corporation: Model Number U228, VISIONIST CRT-P EL MRI
Medical DevicesFDA (device) · 2025-10-22 · Class I
Boston Scientific Corporation: TENACIO Pump with InhibiZone; UPN: 72404429;
Medical DevicesFDA (device) · 2025-10-22 · Class II
Boston Scientific Corporation: TENACIO Pump without InhibiZone; UPN: 72404420;
Medical DevicesFDA (device) · 2025-10-22 · Class II
Boston Scientific Corporation: CX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404486 (15CM IP), (2) 72404488 (21CM IP);
Medical DevicesFDA (device) · 2025-10-22 · Class II
Boston Scientific Corporation: LGX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404405 (12CM IP), (2) 72404407 (18CM IP);
Medical DevicesFDA (device) · 2025-10-22 · Class II
Boston Scientific Corporation: CX Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404430 (12CM PS IZ), (2) 72404431 (15CM PS IZ), (3) 72404432 (18CM PS IZ)
Medical DevicesFDA (device) · 2025-10-22 · Class II
Boston Scientific Corporation: CXR Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404461 (12CM PS IZ), (2) 72404462 (14CM PS IZ), (3) 72404463 (16CM PS IZ
Medical DevicesFDA (device) · 2025-10-22 · Class II
Boston Scientific Corporation: LGX Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404450 (12CM PS IZ), (2) 72404451 (15CM PS IZ), (3) 72404452 (18CM PS IZ
Medical DevicesFDA (device) · 2025-10-22 · Class II
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