Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A;
FDA device recall Z-1437-2026 · posted 2026-02-20 · Open, Classified
Recall details
- Recalling firm
- Olympus Corporation of the Americas
- 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.
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- GCP
- Quantity affected
- 633 units
- Distribution
- Distribution US nationwide.
- Date initiated
- 2024-09-13
- Date posted
- 2026-02-20
- Location
- Center Valley, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ENDOSCOPE AND ACCESSORIES (K790071) | Olympus Corp. | 1979-04-02 |