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U.S. Department of Health and Human Services

Class 2 Device Recall Olympus Cystoscope Outer Sheath

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 Class 2 Device Recall Olympus Cystoscope Outer Sheathsee related information
Date Initiated by FirmSeptember 13, 2024
Date PostedFebruary 20, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1437-2026
Recall Event ID 98300
510(K)NumberK790071 
Product Classification Endoscope, ac-powered and accessories - Product Code GCP
ProductOlympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A;
Code Information Model: WA2280A; UDI: 04042761051729; Lot#: All lots;
Recalling Firm/
Manufacturer		 Olympus Corporation of the Americas
3500 Corporate Pkwy
Center Valley PA 18034-8229
For Additional Information ContactCynthia Ow
647-999-3203
Manufacturer 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 2		Under Investigation by firm
ActionOn 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.
Quantity in Commerce633 units
DistributionDistribution US nationwide.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = GCP
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