Olympus Cystoscope Outer Sheath recallZ-1437-2026 · Olympus Corporation of the Americas · initiated Sep 13, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Olympus Corporation of the Americas or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-1437-2026
- Status
- Open, Classified
- Initiated by the company
- Sep 13, 2024
- Posted by the FDA
- Feb 20, 2026
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 633 units
- Product code
- GCP
- FDA submissions
- K790071
- Distribution
- Distribution US nationwide.
Product description
Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A;
Code information (models, lots, serial numbers)
Model: WA2280A; UDI: 04042761051729; Lot#: All lots;
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Olympus WA22810AOLYMPUS Winter & Ibe GmbH · Endoscope, Ac-Powered And Accessories2 recalls8 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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