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Olympus Corporation of the Americas: Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm. Model Number: TB2-0545FC.

Medical DevicesSource: FDA (device) · Date: 2026-04-29

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Olympus Corporation of the Americas
Product
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm. Model Number: TB2-0545FC.
Reason / hazard
Potential for detachment of a distal tip component of the device during use.
Classification
Class II
Status
Ongoing
Distribution / sold at
International distribution in the countries of Australia, Japan, Hong Kong, and Europe.
Recall initiated
2026-03-23
Code info
Model Number: TB2-0545FC. UDI-DI: 04953170440021. All Lot Numbers.
Product quantity
490 units
Voluntary mandated
Voluntary: Firm initiated
City
Center Valley
State
PA
Country
United States
Event id
98550
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