[pending] Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A;
Pending LLM rewrite. Source: FDA_DEVICE Z-1437-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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 recalled product
- Product
- Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A;
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model: WA2280A
- UDI: 04042761051729
- Lot#: All lots
Distribution
Distributed nationwide across the United States.
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