EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-P190
Pending LLM rewrite. Source: FDA_DEVICE Z-0057-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
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 recalled product
- Product
- EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-P190
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model No. BF-P190
- UDI: 4953170342110
- All Serial No.
Distribution
Distributed nationwide across the United States.
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