Olympus Corporation Of The Americas: Electrosurgical, Cutting & Coagulation & Accessories

Olympus is recalling Thunderbeat II Shears (Model TB2-0535FC), a surgical cutting device used in medical procedures, because the tip component may detach during use. This is a Class II recall affecting devices distributed in Australia, Japan, Hong Kong, and Europe. The recall applies to medical facilities and healthcare providers who use this equipment.

Recalling firm

Olympus Corporation of the Americas

Product

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

Reason

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

Classification

Class II

Category

medical device recall

Country

United States

Agency

FDA-DEVICES

Recall date

2026-03-23

Status

Open, Classified

Distribution

International distribution in the countries of Australia, Japan, Hong Kong, and Europe.

Official recall notice from FDA-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/a4df4c0d-9f3c-4549-bcb1-4550e5bda745