FDA recall Z-1437-2026

Olympus Corporation of the Americas · Class II · device

Product

Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A;

Reason for recall

Product being removed due to incompatibility when used in conjunction with a GreenLight Laser for BPH therapy which could damage the tip of the device.

Distribution

Distribution US nationwide.

Key facts

Status: Ongoing
Initiation date: 2024-09-13
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-1437-2026