FDA Medical devices recall ·
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-Q190 recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-0063-2026
- 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
- 916 units US; 1,402 units OUS
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-Q190
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-Q190; UDI: 4953170434792, 4953170335198; 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-0063-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.