Official recall notice

FDA DeviceClass IINotable

FDA Recall: Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 25cm. Model Number: TB2-0525FC.

Recall date
2026-04-29
FDA class
Class II

Why it was recalled

Hazard

Potential for detachment of a distal tip component of the device during use.

Recommended action

What to do

365 units

Product description

Potential for detachment of a distal tip component of the device during use.

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