FDA Enforcement
Class I
Ongoing
EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS BF-XT190
Recall: Z-0066-2026
·
Reported October 22, 2025
Enforcement
- Recall Number
- Z-0066-2026
- 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 b BRONCHOVIDEOSCOPE OLYMPUS BF-XT190
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-XT190; UDI: 4953170402470; All Serial No.
Distribution
US Nationwide Distribution.
Quantity
361 units US; 258 units OUS