FDA recall Z-0063-2026

Olympus Corporation of the Americas · Class I · device

Product

EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-Q190

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.

Distribution

US Nationwide Distribution.

Key facts

Status: Ongoing
Initiation date: 2025-09-11
Report date: 2025-10-22
Voluntary/Mandated: Voluntary: Firm initiated
Location: Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0063-2026