Official recall notice

FDA DeviceClass IINotable

FDA Recall: Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A;

Recall date
2026-03-04
FDA class
Class II

Why it was recalled

Hazard

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.

Recommended action

What to do

633 units

Product description

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.

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