Z-1853-2026 Class II Ongoing
FDA device recall Z-1853-2026 was initiated by Olympus Corporation of the Americas on March 23, 2026 and is designated Class II. Reason for recall: Potential for detachment of a distal tip component of the device during use. The recall status is ongoing. Affected quantity: 3,360 units.
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
- 3,360 units
Product Description
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm. Model Number: TB2-0535FC.
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: TB2-0535FC. UDI-DI: 04953170440014. All Lot Numbers.