FDA-Device2025-10-22Class I
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-Q190
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
916 units US; 1,402 units OUS
Manufactured in
3500 Corporate Pkwy, Center Valley, PA, United States
Products
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-Q190
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0063-2026More Olympus Corporation of the Americas recalls
- FDA-Device2026-07-22Olympus Ellik Evacuator Model 194 recalled for inadequate sterilization parameters
- FDA-Device2026-07-22Olympus Toomey Evacuator 30cc with Adaptor recalled for inadequate sterilization
- FDA-Device2026-07-22Olympus Glass Body for 194 Ellik Evacuator recalled for inadequate sterilization
- FDA-Device2026-07-22Olympus Toomey Evacuator 50cc Model 188A recalled for inadequate sterilization parameters
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