HIGH

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.

Quick Facts at a Glance

Recall Date
September 13, 2024
Hazard Level
HIGH
Brand
Olympus Corporation of the Americas
Geographic Scope
1 states

Hazard Information

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 You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Olympus Corporation of the Americas or your healthcare provider for instructions. Notification method: Letter

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Full Description

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. Quantity: 633 units. Distribution: Distribution US nationwide.

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Product Classification

Product Details

Model Numbers
Model: WA2280A
UDI: 04042761051729
Lot#: All lots
Affected States
ALL
Report Date
March 4, 2026
Recall Status
ACTIVE

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