Z-1437-2026 Class II Ongoing
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;