Recall Z-1437-2026 ยท GCP Endoscope, Ac-Powered And Accessories
Olympus Corporation of the Americas
Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A;
| Date | Feb 20, 2026 (initiated Sep 13, 2024) |
| Status | Open, Classified |
| Reason | 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 | Under Investigation by firm |
| Action | 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 WA2281 |
| Quantity | 633 units |
| Distribution | Distribution US nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K790071 | ENDOSCOPE AND ACCESSORIES Olympus Corp., Apr 2, 1979 |