Olympus Corporation Of The Americas: Electrosurgical, Cutting & Coagulation & Accessories
Olympus is recalling Thunderbeat II Shears (Model TB2-0545FC), a surgical cutting device used in medical procedures, because the tip component may detach during use. This recall affects devices distributed in Australia, Japan, Hong Kong, and Europe. The company has classified this as a Class II recall, indicating a potential health hazard.
- Recalling firm
- Olympus Corporation of the Americas
- Product
- Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm. Model Number: TB2-0545FC.
- 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/589f4831-4edb-417e-ad4f-5402467c250a