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High risk Medical DevicesClass II

Olympus Thunderbeat II Shears Recall

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

Updated March 23, 2026

Olympus Thunderbeat II Shears (Model TB2-0545FC) can lose a component from the tip during surgery, potentially leaving debris in the patient. If you use this device professionally, stop and contact Olympus immediately.

Is the Olympus Corporation of the Americas recalled? Yes. This product was recalled by FDA on March 23, 2026. Details below.

What is recalled

Olympus Thunderbeat II Shears with Ultrasonic Mode, 5mm, 45cm length, Model Number TB2-0545FC.

Am I affected

You are affected if you own or use an Olympus Thunderbeat II Shears device with Model Number TB2-0545FC.

What to do right now

Stop using this device immediately. Contact Olympus Corporation of the Americas for instructions on repair, replacement, or return.

The hazard

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

Brands affected

Olympus Corporation of the Americas
Source
FDA
Category
Medical Devices
Recall ID
fda-Z-1854-2026
Classification
Class II
Recalled
March 23, 2026
Read the official notice

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