Olympus Corporation Of The Americas: Olympus Thunderbeat II Shears W/ultrasonic Mode, 5mm, 35cm. Model Number: Tb2-0535fc
Recall Summary Olympus Corporation of the Americas is recalling Thunderbeat II Shears (Model TB2-0535FC), a surgical instrument used in medical procedures, because the tip of the device may detach during use. The product was distributed in Australia, Japan, Hong Kong, and Europe. This is classified as a Class II recall.
- 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
- 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/e6cab712-83d7-4334-a6a5-bc9d4e96cb8d