Z-0061-2026 Class I Ongoing
FDA device recall Z-0061-2026 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: 665 units US; 2,250 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
- 665 units US; 2,250 units OUS
Product Description
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180
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-Q180; UDI: 4953170339301; All Serial No.