FDA DeviceClass IINotable

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

Date: 2026-04-29
Brand: Olympus Corporation of the Americas
Category: Medical Device
FDA Class: Class II

Description

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

Hazard

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

Remedy

3,360 units

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