Official recall notice

FDA DeviceClass IINotable

FDA Recall: Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm. Model Number: TB2-0535FC.

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

3,360 units

Product description

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

Verify with the official notice →
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