FDA recall Z-1438-2026

Olympus Corporation of the Americas · Class II · device

Product

Olympus Resection Sheath. Model No. A22014A and A22014T. for endoscopic diagnosis and treatment in urological applications.

Reason for recall

Complaints of the ceramic tip of the resection sheath breaking have been received.

Distribution

US Nationwide Distribution.

Key facts

Status
Ongoing
Initiation date
2025-11-11
Report date
2026-03-04
Voluntary/Mandated
Voluntary: Firm initiated
Location
Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1438-2026