FDA Medical devices recall ·
Olympus Cystoscope Outer Sheath recall
- Recall number
- Z-1437-2026
- Date
- (initiated September 13, 2024)
- Company / brand
- Olympus Corporation of the Americas
3500 Corporate Pkwy, Center Valley, PA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 633 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A;
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model: WA2280A; UDI: 04042761051729; Lot#: All lots;
Distribution
Distribution US nationwide.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1437-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.