FDA recall Z-1851-2026

Olympus Corporation of the Americas · Class II · device

Product

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

International distribution in the countries of Australia, Japan, Hong Kong, and Europe.

Key facts

Status
Ongoing
Initiation date
2026-03-23
Report date
2026-04-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1851-2026