FDA DevicesClass II
Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A;
Published: March 4, 2026Recall ID: Z-1437-2026Category: devicesCountry: US
Reason for Recall / Hazard
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.
Product Description & Identification
Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A;
Affected Products
Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A;
Additional Source Details
| Field | Value |
|---|---|
| City | Center Valley |
| State | PA |
| Event id | 98300 |
| Address 1 | 3500 Corporate Pkwy |
| Address 2 | N/A |
| Code info | Model: WA2280A; UDI: 04042761051729; Lot#: All lots; |
| Postal code | 18034-8229 |
| Report date | 20260304 |
| Product type | Devices |
| Product quantity | 633 units |
| 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20240913 |
| Initial firm notification | Letter |
| Center classification date | 20260220 |
Overview
- Recalling FirmOlympus Corporation of the Americas
- StatusOngoing
- Risk LevelClass II
- DistributionDistribution US nationwide.