FDA Medical devices recall ·
BRONCHOFIBERSCOPE OLYMPUS BF TYPE TE2 recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-0064-2026
- 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; 5,286 units OUS
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
BRONCHOFIBERSCOPE OLYMPUS BF TYPE TE2
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-TE2; UDI: 4953170339998; 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-0064-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.