BRONCHOVIDEOSCOPE OLYMPUS BF-Q170

FDA Recall #Z-0060-2026 — Class I — September 11, 2025

Recall #Z-0060-2026 Date: September 11, 2025 Classification: Class I Status: Ongoing

Product Description

BRONCHOVIDEOSCOPE OLYMPUS BF-Q170

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 unit US; 2,306 units OUS

Distribution

US Nationwide Distribution.

Code Information

Model No. BF-Q170; UDI: 4953170342912; All Serial No.

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated