Recall Z-1437-2026
Olympus Corporation of the Americas · initiated September 13, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A;
Codes / lots: Model: WA2280A; UDI: 04042761051729; Lot#: All lots;
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.
FDA-determined cause: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-1437-2026
- Initiated
- September 13, 2024
- Posted by FDA
- February 20, 2026
- Product code
- GCP – Endoscope, Ac-Powered And Accessories
- Quantity
- 633 units
- Distribution
- Distribution US nationwide.
- Recalling firm
- Olympus Corporation of the Americas, Center Valley, PA