FDA recall Z-0058-2026

Olympus Corporation of the Americas · Class I · device

Product

OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE P60

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-0058-2026