FDAFDA · Food and drugs·Recall number Z-0065-2026
EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE XT160
Published October 22, 2025 · Recall initiated: September 11, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- Olympus Corporation of the Americas
- Distributor
- US Nationwide Distribution.
- Lot
- Model No. BF-XT160; UDI: 4953170340147; All Serial No.
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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