Recalling firm
Olympus Corporation of the Americas
Product type
Device
Status
Ongoing
Report date
2026-04-29
Distribution
International distribution in the countries of Australia, Japan, Hong Kong, and Europe.
Firm state
PA
Product quantity
3,360 units
Initiated by
Voluntary: Firm initiated
Reason for recall
Potential for detachment of a distal tip component of the device during use.
Product description
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm. Model Number: TB2-0535FC.
Code / lot info
Model Number: TB2-0535FC. UDI-DI: 04953170440014. All Lot Numbers.
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.