Z-0066-2026 Class I Ongoing
FDA device recall Z-0066-2026 was initiated by Olympus Corporation of the Americas on September 11, 2025 and is designated Class I. Reason for recall: 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. The recall status is ongoing. Affected quantity: 361 units US; 258 units OUS.
Recall Details
- Product Type
- Devices
- Report Date
- October 22, 2025
- Initiation Date
- September 11, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 361 units US; 258 units OUS
Product Description
EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS BF-XT190
Reason for Recall
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.
Distribution Pattern
US Nationwide Distribution.
Code Information
Model No. BF-XT190; UDI: 4953170402470; All Serial No.