Z-0057-2026 Class I Ongoing
FDA device recall Z-0057-2026 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: 3,046 units US; 2,414 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
- 3,046 units US; 2,414 units OUS
Product Description
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-P190
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-P190; UDI: 4953170342110; All Serial No.