FDAHealthSeptember 13, 2024
Olympus Corporation of the Americas — Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A;
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- September 13, 2024
Distribution US nationwide.
What's affected?
- Product
- Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A;
- Lot code
- All
Additional details
Model: WA2280A; UDI: 04042761051729; Lot#: All lots;
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 633 units.
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