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Z-1853-2026Class II
Olympus Corporation of the Americas
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
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. 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. Open the enforcement explorer →