Z-1851-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- April 29, 2026
- Initiation Date
- March 23, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 830 units
Product Description
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm. Model Number: TB2-0520FC.
Reason for Recall
Potential for detachment of a distal tip component of the device during use.
Distribution Pattern
International distribution in the countries of Australia, Japan, Hong Kong, and Europe.
Code Information
Model Number: TB2-0520FC. UDI-DI Number: 04953170439995. All Lot Numbers.