Class IIOngoingZ-2840-2026
Boston Scientific Corporation recalls Radial Jaw 4 Jumbo Biopsy Forceps with the following descriptions and UPN: Radial…
Potential for breach in sterile barrier of device packaging.
Boston Scientific Corp…MAAug 12, 2026
Boston Scientific Corporation recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–12 of 124 recalls
Class IIOngoingZ-2839-2026
Boston Scientific Corporation recalls Radial Jaw 4 Large Capacity Biopsy Forceps with the following descriptions and UPN:…
Potential for breach in sterile barrier of device packaging.
Boston Scientific Corp…MAAug 12, 2026
Class IIOngoingZ-2838-2026
Boston Scientific Corporation recalls Radial Jaw 4 Standard Capacity Biopsy Forceps with the following descriptions and UPN:…
Potential for breach in sterile barrier of device packaging.
Boston Scientific Corp…MAAug 12, 2026
Class IIOngoingZ-2771-2026
Boston Scientific Corporation recalls Boston Scientific TheraSphere 360 Y-90 Management Platform
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.…
Boston Scientific Corp…MNJul 29, 2026
Class IIOngoingZ-2757-2026
Boston Scientific Corporation recalls FARADRIVE STEERABLE SHEATH CLEAR OUS
Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation.…
Boston Scientific Corp…MNJul 29, 2026
Class IIOngoingZ-2756-2026
Boston Scientific Corporation recalls FARADRIVE STEERABLE SHEATH (CLEAR) - US
Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation.…
Boston Scientific Corp…MNJul 29, 2026
Class IIOngoingZ-2755-2026
Boston Scientific Corporation recalls FARADRIVE STEERABLE SHEATH CLEAR
Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation.…
Boston Scientific Corp…MNJul 29, 2026
Class IIOngoingZ-2754-2026
Boston Scientific Corporation recalls FARADRIVE Steerable Sheath Clear IDE
Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation.…
Boston Scientific Corp…MNJul 29, 2026
Class IIOngoingZ-2753-2026
Boston Scientific Corporation recalls FARASTAR Ablation Generator EU
Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter.
- Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
- Under Investigation by firm
Boston Scientific Corp…MNJul 29, 2026
Class IIOngoingZ-2752-2026
Boston Scientific Corporation recalls FARASTAR PFA Generator
Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.
- Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
- Under Investigation by firm
Boston Scientific Corp…MNJul 29, 2026
Class IIOngoingZ-2751-2026
Boston Scientific Corporation recalls FARASTAR Pulsed Field Ablation Generator
Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.
- Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
- Under Investigation by firm
Boston Scientific Corp…MNJul 29, 2026
Class IIOngoingZ-2750-2026
Boston Scientific Corporation recalls FARASTAR Ablation Generator EU
Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.
- Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
- Under Investigation by firm
Boston Scientific Corp…MNJul 29, 2026