FDAHealthMarch 23, 2026
Olympus Corporation of the Americas — Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm. Model Number: TB2-0535FC.
⚠️ Potential for detachment of a distal tip component of the device during use.
Is this relevant to me?
- Geography
- Unknown
- Source agency
- FDA
- Category
- Health
- Published
- March 23, 2026
International distribution in the countries of Australia, Japan, Hong Kong, and Europe.
What's affected?
- Product
- Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm. Model Number: TB2-0535FC.
- Lot code
- s
Additional details
Model Number: TB2-0535FC. UDI-DI: 04953170440014. All Lot Numbers.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 3,360 units.
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