Olympus Corporation Of The Americas: Olympus Thunderbeat II Shears W/ultrasonic Mode, 5mm, 45cm. Model Number: Tb2-0545fc
Recall Summary Olympus is recalling Thunderbeat II Shears (Model TB2-0545FC), a surgical instrument used in medical procedures, because a component at the tip of the device may detach during use. The device was distributed in Australia, Japan, Hong Kong, and Europe.
- 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
- U.S. Food and Drug Administration
- Recall date
- 2026-03-23
- Status
- Ongoing
- Distribution
- International distribution in the countries of Australia, Japan, Hong Kong, and Europe.
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/29ed62d6-b75b-4115-a4e2-cbaa3980dbc9