FDA-Device2025-10-22Class I
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-H190
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.
Sold states
US Nationwide Distribution.
Affected count
5,221 units US; 4,321 units OUS
Manufactured in
3500 Corporate Pkwy, Center Valley, PA, United States
Products
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-H190
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0053-2026More Olympus Corporation of the Americas recalls
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- FDA-Device2026-07-22Olympus Toomey Evacuator 30cc with Adaptor recalled for inadequate sterilization
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