Z-1437-2026 Class II Ongoing
FDA device recall Z-1437-2026 was initiated by Olympus Corporation Of The Americas on Sep 13, 2024 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 633 units.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 4, 2026
- Initiation Date
- Sep 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;
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1437-2026
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026