FDA-Device2025-10-22Class I
OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE MP60
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
59 units US; 665 units OUS
Manufactured in
3500 Corporate Pkwy, Center Valley, PA, United States
Products
OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE MP60
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0054-2026More 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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