FDAHealthSeptember 11, 2025
Olympus Corporation of the Americas — BRONCHOVIDEOSCOPE OLYMPUS BF-H1100
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- September 11, 2025
US Nationwide Distribution.
What's affected?
- Product
- BRONCHOVIDEOSCOPE OLYMPUS BF-H1100
- Lot code
- Model No. BF-H1100; UDI: 4953170424229; All Serial No.
Additional details
Model No. BF-H1100; UDI: 4953170424229; All Serial No.
What should I do?
Recommended action
Class I recall. Voluntary: Firm initiated Quantity affected: 0 units US; 1,867 units OUS.
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