—#218207

Product

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

FDA product code: GCP — Endoscope, Ac-Powered And Accessories
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K790071
Affected lot / code info: Model: WA2280A; UDI: 04042761051729; Lot#: All lots;

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

On January 15, 2026 URGENT: MEDICAL DEVICE REMOVAL letters were sent to customers. Actions to be taken: 1. Examine your inventory and quarantine any identified devices immediately. 2. Immediately cease usage of any affected products in your inventory. 3. Olympus requests that you acknowledge receipt of this letter through the recall web portal provided. 4. Please contact Customer Service at 1-800-848-9024, option 2, to obtain a Return Material Authorization. Olympus will arrange for the return of your device to Olympus. Olympus will issue a credit to your facility upon receipt of your WA22810A outer sheath. 5. If you have further distributed this product, please forward this notification to other users.

Recalling firm

Firm: Olympus Corporation of the Americas
Address: 3500 Corporate Pkwy, Center Valley, Pennsylvania 18034-8229

Distribution

Distribution pattern: Distribution US nationwide.

Timeline

Recall initiated: 2024-09-13
Posted by FDA: 2026-02-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #218207. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.