Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A;
FDA Recall Z-1437-2026 · Posted 2026-02-20
Advertisement
Recalling FirmOlympus Corporation of the Americas
Recall StatusOpen, Classified
Product CodeGCP
Date Initiated2024-09-13
Product Quantity633 units
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.
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 WA22810A outer sheath.
5. If you have further distributed this product, please forward this notification to other users.
Root Cause
Under Investigation by firm
Distribution Pattern
Distribution US nationwide.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement