Olympus Corporation of the Americas recalls Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A;

Recall date

September 13, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1437-2026

FDA classification

Class II

Brand / firm

Olympus Corporation of the Americas

Sold / distributed

Distribution US nationwide.

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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