Boston Scientific recalls

Boston Scientific appears in 655 official U.S. recall notices indexed by RecallRadar, most recently on 2026-08-26.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

• OverStitch Suture Cinch, 1pk
  FDA Device · Class II · 2026-08-26 · Boston Scientific
• Suture Cinch Long 1pk
  FDA Device · Class II · 2026-08-26 · Boston Scientific
• Boston Scientific ENROUTE Transcarotid Neuroprotection System, Material Number SR-200-NPS
  FDA Device · Class I · 2026-08-26 · Boston Scientific
• Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus, Material Number SR-250-NPS
  FDA Device · Class I · 2026-08-26 · Boston Scientific
• Radial Jaw 4 Large Capacity Biopsy Forceps with the following descriptions and UPN: 1. Radial Jaw 4 LC 240cm Box 20
  FDA Device · Class II · 2026-08-12 · Boston Scientific
• Radial Jaw 4 Standard Capacity Biopsy Forceps with the following descriptions and UPN: 1. Radial Jaw 4 SC 240cm Box 20
  FDA Device · Class II · 2026-08-12 · Boston Scientific
• Radial Jaw 4 Jumbo Biopsy Forceps with the following descriptions and UPN: Radial Jaw 4 Jumbo 240cm Box 5
  FDA Device · Class II · 2026-08-12 · Boston Scientific
• FARADRIVE STEERABLE SHEATH (CLEAR) - US, used to facilitate access to the vasculature and into the chambers of the heart, Material Number M…
  FDA Device · Class II · 2026-07-29 · Boston Scientific
• FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401
  FDA Device · Class II · 2026-07-29 · Boston Scientific
• FARASTAR PFA Generator, Product ID M004PFCE61M460
  FDA Device · Class II · 2026-07-29 · Boston Scientific
• FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21M402,…
  FDA Device · Class II · 2026-07-29 · Boston Scientific
• FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401
  FDA Device · Class II · 2026-07-29 · Boston Scientific
• FARADRIVE STEERABLE SHEATH CLEAR OUS, used to facilitate access to the vasculature and into the chambers of the heart, Material Number M004…
  FDA Device · Class II · 2026-07-29 · Boston Scientific
• Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001
  FDA Device · Class II · 2026-07-29 · Boston Scientific
• FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401
  FDA Device · Class II · 2026-07-29 · Boston Scientific
• FARADRIVE Steerable Sheath Clear IDE, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21C6…
  FDA Device · Class II · 2026-07-29 · Boston Scientific
• Rapid Refill Continuous Injection System, UPN M00566001
  FDA Device · Class II · 2026-07-22 · Boston Scientific
• CRE Wireguided 10-12mm 240cm
  FDA Device · Class II · 2026-07-08 · Boston Scientific
• CRE Wireguided 15-18mm 240cm
  FDA Device · Class II · 2026-07-08 · Boston Scientific
• CRE Wireguided 6-8mm 240cm
  FDA Device · Class II · 2026-07-08 · Boston Scientific
• CRE Pro Wireguided 6-8mm 240cm
  FDA Device · Class II · 2026-07-08 · Boston Scientific
• CRE Wireguided 8-10mm 240cm
  FDA Device · Class II · 2026-07-08 · Boston Scientific
• CRE Pro Wireguided 15-18mm 240cm
  FDA Device · Class II · 2026-07-08 · Boston Scientific
• CRE Pro Wireguided 18-20mm 240cm
  FDA Device · Class II · 2026-07-08 · Boston Scientific
• CRE Wireguided 12-15mm 240cm
  FDA Device · Class II · 2026-07-08 · Boston Scientific
• CRE Pro Wireguided 12-15mm 240cm
  FDA Device · Class II · 2026-07-08 · Boston Scientific
• CRE Pro Wireguided 8-10mm 240cm
  FDA Device · Class II · 2026-07-08 · Boston Scientific
• CRE Pro Wireguided 10-12mm 240cm
  FDA Device · Class II · 2026-07-08 · Boston Scientific
• CRE Wireguided 18-20mm 240cm
  FDA Device · Class II · 2026-07-08 · Boston Scientific
• Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable drug delivery device
  FDA Device · Class II · 2026-07-01 · Boston Scientific
• Orca Single Use Air/Water and Suction Valves, Material Number (UPN) SUV-617-50
  FDA Device · Class II · 2026-06-17 · Boston Scientific
• 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…
  FDA Device · Class II · 2026-05-13 · Boston Scientific
• LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5
  FDA Device · Class II · 2026-05-13 · Boston Scientific
• Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VALITUDE CRT-P EL, Model Number U125
  FDA Device · Class I · 2026-05-06 · Boston Scientific
• Boston Scientific Pacemaker, Implantable Pulse Generator, Pacemaker (non- Cardiac Re-Synchronization Therapy) labeled as: 1. ESSENTIO SR SL…
  FDA Device · Class I · 2026-05-06 · Boston Scientific
• EndoVive Safety PEG Kit
  FDA Device · Class II · 2026-03-18 · Boston Scientific
• HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm
  FDA Device · Class I · 2026-02-11 · Boston Scientific
• AXIOS Stent and Electrocautery-Enhanced Delivery System - 8mm x 8mm
  FDA Device · Class I · 2026-02-11 · Boston Scientific
• *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mm x 8mm
  FDA Device · Class I · 2026-02-11 · Boston Scientific
• AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm
  FDA Device · Class I · 2026-02-11 · Boston Scientific
• *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm
  FDA Device · Class I · 2026-02-11 · Boston Scientific
• AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm
  FDA Device · Class I · 2026-02-11 · Boston Scientific
• Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F, 1) 2.5mm x120mm, 150 cm, UPM/Model No. REF H74939186251210
  FDA Device · Class II · 2026-01-21 · Boston Scientific
• Model Number L110, ESSENTIO SR SL MRI Pacemaker
  FDA Device · Class I · 2025-10-22 · Boston Scientific
• CX Preconnect with TENACIO Pump with InhibiZone
  FDA Device · Class II · 2025-10-22 · Boston Scientific
• TENACIO Pump without InhibiZone
  FDA Device · Class II · 2025-10-22 · Boston Scientific
• Model Number L211 PROPONENT DR SL MRI Pacemaker
  FDA Device · Class I · 2025-10-22 · Boston Scientific
• ACCOLADE DR EL (Model L321)
  FDA Device · Class I · 2025-10-22 · Boston Scientific
• Model Number U125, VALITUDE CRT-P EL
  FDA Device · Class I · 2025-10-22 · Boston Scientific
• CX Preconnect with TENACIO Pump without InhibiZone
  FDA Device · Class II · 2025-10-22 · Boston Scientific