FDA recall Z-1375-2026

Olympus Corporation of the Americas · Class II · device

Product

Olympus Thunderbeat 5 mm, 35 cm, Front-Actuated Grip

Reason for recall

Firm is initiating a removal due to continued reports of adverse events.

Distribution

Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Germany, Mexico, and Japan.

Key facts

Status
Ongoing
Initiation date
2025-10-22
Report date
2026-02-25
Voluntary/Mandated
Voluntary: Firm initiated
Location
Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1375-2026