FDA Medical devices recall ·

BRONCHOVIDEOSCOPE OLYMPUS BF-Q170 recall

This is an FDA Class I recall — the most serious type.

Recall number
Z-0060-2026
Date
(initiated September 11, 2025)
Company / brand
Olympus Corporation of the Americas
3500 Corporate Pkwy, Center Valley, PA, United States
Category
Medical devices › Class I
Classification
Class I
Status
Ongoing
Units affected
1 unit US; 2,306 units OUS
Initiated by
Voluntary: Firm initiated

Read the official FDA notice ↗

Product

BRONCHOVIDEOSCOPE OLYMPUS BF-Q170

Why was it 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.

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

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

Distribution

US Nationwide Distribution.

What does Class I mean?

Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.

Source: FDA (medical devices), recall Z-0060-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.