Z-1437-2026 Class II Ongoing

Recalled by Olympus Corporation of the Americas — Center Valley, PA

Recall Details

Product Type
Devices
Report Date
March 4, 2026
Initiation Date
September 13, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
633 units

Product Description

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 Pattern

Distribution US nationwide.

Code Information

Model: WA2280A; UDI: 04042761051729; Lot#: All lots;