PlainRecalls
FDA Devices Critical Class I Ongoing

EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE XT160

Reported: October 22, 2025 Initiated: September 11, 2025 #Z-0065-2026

Product Description

EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE XT160

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
262 units US; 558 units OUS
Distribution
US Nationwide Distribution.
Location
Center Valley, PA

Frequently Asked Questions

What product was recalled?
EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE XT160. Recalled by Olympus Corporation of the Americas. Units affected: 262 units US; 558 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-0065-2026.