EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-1TH190
FDA Recall #Z-0049-2026 — Class I — September 11, 2025
Product Description
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-1TH190
Reason for Recall
Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
Recalling Firm
Olympus Corporation of the Americas — Center Valley, PA
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Devices
Product Quantity
4,297 units US; 4,290 units OUS
Distribution
US Nationwide Distribution.
Code Information
Model No. BF-1TH190; UDI: 4953170434778; All Serial No.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated