FDAClass IIMarch 4, 2026

Olympus Cystoscope Outer Sheath recall

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

Why was Olympus Cystoscope Outer Sheath 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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A;
Recalling firm
Olympus Corporation of the Americas
Quantity
633 units
Distribution
Distribution US nationwide.
Recall date
March 4, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls