FDA-Device2025-10-22Class I
OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE 1T60
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
347 units US; 2,869 units OUS
Manufactured in
3500 Corporate Pkwy, Center Valley, PA, United States
Products
OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE 1T60
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0047-2026More Olympus Corporation of the Americas recalls
- FDA-Device2026-07-29Olympus OEV321UH 4K UHD LCD Monitor recalled for faulty HDMI and DisplayPort connectors
- FDA-Device2026-07-29Olympus High Flow Insufflation Unit UHI-4 recalled for unexpected display shutdown and air delivery loss
- FDA-Device2026-07-22Olympus Toomey Evacuator 50cc Model 188A recalled for inadequate sterilization parameters
- FDA-Device2026-07-22Olympus Glass Body for 194 Ellik Evacuator recalled for inadequate sterilization
- FDA-Device2026-07-22Olympus Toomey Evacuator 30cc with Adaptor recalled for inadequate sterilization
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