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Olympus Corporation of the Americas recalls EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-H190
Recalled October 22, 2025 · FDA recall Z-0053-2026 · Olympus Corporation of the Americas
Hazard
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. · FDA Class I
Units
5,221 units US; 4,321 units OUS
Sold at
US Nationwide Distribution.
Description
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.
Product
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-H190
Manufacturer(s)
Olympus Corporation of the Americas
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →