FDA Enforcement
Class I
Ongoing
EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE XT160
Recall: Z-0065-2026
·
Reported October 22, 2025
Enforcement
- Recall Number
- Z-0065-2026
- Event ID
- 97441
- Classification
- Class I
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Olympus Corporation of the Americas
- Voluntary / Mandated
- Voluntary: Firm initiated
- Report Date
- October 22, 2025
- Initiation Date
- September 11, 2025
- Classification Date
- October 16, 2025
- Address
- 3500 Corporate Pkwy, Center Valley, PA, 18034-8229, United States
Description
EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE XT160
Reason
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.
Code Info
Model No. BF-XT160; UDI: 4953170340147; All Serial No.
Distribution
US Nationwide Distribution.
Quantity
262 units US; 558 units OUS