EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P180
FDA Recall #Z-0056-2026 — Class I — September 11, 2025
Product Description
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P180
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
1,070 units US; 2,180 units OUS
Distribution
US Nationwide Distribution.
Code Information
Model No. BF-P180; UDI: 4953170339288; All Serial No.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated