Boston Scientific recalls

31 recent recalls on record for Boston Scientific in connected official government data as of September 7, 2026 at 6:00 AM UTC.

Models with recalls

Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as (1)Boston Scientific Pacemaker (1)Boston Scientific TheraSphere 360 Y-90 Management Platform (1)CRE Pro Wireguided 10-12mm 240cm (1)CRE Pro Wireguided 12-15mm 240cm (1)CRE Pro Wireguided 15-18mm 240cm (1)CRE Pro Wireguided 18-20mm 240cm (1)CRE Pro Wireguided 6-8mm 240cm (1)CRE Pro Wireguided 8-10mm 240cm (1)CRE Wireguided 10-12mm 240cm (1)CRE Wireguided 12-15mm 240cm (1)CRE Wireguided 15-18mm 240cm (1)CRE Wireguided 18-20mm 240cm (1)CRE Wireguided 6-8mm 240cm (1)CRE Wireguided 8-10mm 240cm (1)FARADRIVE STEERABLE SHEATH (CLEAR) - US (1)FARADRIVE STEERABLE SHEATH CLEAR (1)FARADRIVE STEERABLE SHEATH CLEAR OUS (1)FARADRIVE Steerable Sheath Clear IDE (1)FARASTAR Ablation Generator EU (2)FARASTAR PFA Generator (1)FARASTAR Pulsed Field Ablation Generator (1)Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump (1)LUX-DX II (1)LUX-Dx II Plus (1)Orca Single Use Air/Water and Suction Valves (1)Radial Jaw 4 Jumbo Biopsy Forceps with the following descriptions and UPN (1)Radial Jaw 4 Large Capacity Biopsy Forceps with the following descriptions and UPN (1)Radial Jaw 4 Standard Capacity Biopsy Forceps with the following descriptions and UPN (1)Rapid Refill Continuous Injection System (1)

All Boston Scientific recalls

FDA Class II · Medical device · August 12, 2026

Radial Jaw 4 Jumbo Biopsy Forceps with the following descriptions and UPN recall — Boston Scientific Corporation

Potential for breach in sterile barrier of device packaging.

Official ID Z-2840-2026 · Official record ↗

FDA Class II · Medical device · August 12, 2026

Radial Jaw 4 Large Capacity Biopsy Forceps with the following descriptions and UPN recall — Boston Scientific Corporation

Potential for breach in sterile barrier of device packaging.

Official ID Z-2839-2026 · Official record ↗

FDA Class II · Medical device · August 12, 2026

Radial Jaw 4 Standard Capacity Biopsy Forceps with the following descriptions and UPN recall — Boston Scientific Corporation

Potential for breach in sterile barrier of device packaging.

Official ID Z-2838-2026 · Official record ↗

FDA Class II · Medical device · July 29, 2026

Boston Scientific TheraSphere 360 Y-90 Management Platform recall — Boston Scientific Corporation

Software anomaly occurs when a user adds one or more vials to the cart and subsequently returns to the Activity Calculator to modify one or more input. When a user modifies an inpu…

Official ID Z-2771-2026 · Official record ↗

FDA Class II · Medical device · July 29, 2026

FARADRIVE STEERABLE SHEATH CLEAR OUS recall — Boston Scientific Corporation

Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orient…

Official ID Z-2757-2026 · Official record ↗

FDA Class II · Medical device · July 29, 2026

FARADRIVE STEERABLE SHEATH (CLEAR) - US recall — Boston Scientific Corporation

Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orient…

Official ID Z-2756-2026 · Official record ↗

FDA Class II · Medical device · July 29, 2026

FARADRIVE STEERABLE SHEATH CLEAR recall — Boston Scientific Corporation

Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orient…

Official ID Z-2755-2026 · Official record ↗

FDA Class II · Medical device · July 29, 2026

FARADRIVE Steerable Sheath Clear IDE recall — Boston Scientific Corporation

Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orient…

Official ID Z-2754-2026 · Official record ↗

FDA Class II · Medical device · July 29, 2026

FARASTAR Ablation Generator EU recall — Boston Scientific Corporation

Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter.

Official ID Z-2753-2026 · Official record ↗

FDA Class II · Medical device · July 29, 2026

FARASTAR PFA Generator recall — Boston Scientific Corporation

Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.

Official ID Z-2752-2026 · Official record ↗

FDA Class II · Medical device · July 29, 2026

FARASTAR Pulsed Field Ablation Generator recall — Boston Scientific Corporation

Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.

Official ID Z-2751-2026 · Official record ↗

FDA Class II · Medical device · July 29, 2026

FARASTAR Ablation Generator EU recall — Boston Scientific Corporation

Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.

Official ID Z-2750-2026 · Official record ↗

FDA Class II · Medical device · July 22, 2026

Rapid Refill Continuous Injection System recall — Boston Scientific Corporation

Devices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There is a risk of syringe loosening or disconnecting from the manifold, resulting in loo…

Official ID Z-2725-2026 · Official record ↗