FDA-Device2025-10-22Class I
EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS BF-XT190
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
361 units US; 258 units OUS
Manufactured in
3500 Corporate Pkwy, Center Valley, PA, United States
Products
EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS BF-XT190
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0066-2026More Olympus Corporation of the Americas recalls
- FDA-Device2026-04-08Olympus SOLTIVE Premium laser system recalled for defective power supply
- FDA-Device2026-04-08Olympus SOLTIVE Pro SuperPulsed Laser System recalled for power supply defect
- FDA-Device2026-04-01Olympus PKS Cutting Forceps recalled for defective welds causing jaw breakage
- FDA-Device2026-04-01Olympus MAJ-1443 and MAJ-1444 endoscope suction valves no longer compatible with OER-Pro and OER-Elite reprocessors
- FDA-Device2026-04-01Olympus PKS Cutting Forceps recalled for defective welds causing jaw breakage
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