Olympus Corporation of the Americas recalls Olympus Cystoscope Outer Sheath
- Recalling company
- Olympus Corporation of the Americas
- Product
- Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A;
- Reason
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Sep 13, 2024
- Reported
- Mar 4, 2026
- Distribution
- Distribution US nationwide.
- Status
- Ongoing
- Quantity
- 633 units
- Lot / codes
- Model: WA2280A; UDI: 04042761051729; Lot#: All lots;
- Company location
- Center Valley, PA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-1437-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-1437-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.