Olympus Corporation Of The Americas: Electrosurgical, Cutting & Coagulation & Accessories
Olympus is recalling Thunderbeat II Shears (Model TB2-0525FC), a surgical cutting device, because the tip component may detach during use. This device was distributed internationally in Australia, Japan, Hong Kong, and Europe. The recall is classified as Class II, indicating a potential health risk but not an immediate danger to life.
- Recalling firm
- Olympus Corporation of the Americas
- Product
- Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 25cm. Model Number: TB2-0525FC.
- 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/86032609-66fe-4640-990c-94ede73c19a3