PlainRecalls
FDA Devices Critical Class I Ongoing

EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180-AC

Reported: October 22, 2025 Initiated: September 11, 2025 #Z-0062-2026

Product Description

EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180-AC

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.

Details

Units Affected
395 units US; 165 units OUS
Distribution
US Nationwide Distribution.
Location
Center Valley, PA

Frequently Asked Questions

What product was recalled?
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180-AC. Recalled by Olympus Corporation of the Americas. Units affected: 395 units US; 165 units OUS.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on October 22, 2025. Severity: Critical. Recall number: Z-0062-2026.