Z-1437-2026Class II

Olympus Corporation of the Americas

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm

Product type

Device

Status

Ongoing

Report date

2026-03-04

Distribution

Distribution US nationwide.

Firm state

Product quantity

633 units

Initiated by

Voluntary: Firm initiated

Reason for recall

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.

Product description

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

Code / lot info

Model: WA2280A; UDI: 04042761051729; Lot#: All lots;

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →