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U.S. Department of Health and Human Services

Class 2 Device Recall Inner Sheath

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 Class 2 Device Recall Inner Sheathsee related information
Date Initiated by FirmNovember 11, 2025
Date PostedFebruary 20, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1456-2026
Recall Event ID 98288
510(K)NumberK931995 
Product Classification Resectoscope - Product Code FJL
ProductOlympus Inner Sheath. Model No. A2642. for endoscopic diagnosis and treatment in urological applications.
Code Information Model No. A2642; UDI: 04042761004084; All Lots.
Recalling Firm/
Manufacturer		 Olympus Corporation of the Americas
3500 Corporate Pkwy
Center Valley PA 18034-8229
For Additional Information ContactCynthia Ow
647-9993203
Manufacturer Reason
for Recall		Complaints of the ceramic tip of the resection sheath breaking have been received.
FDA Determined
Cause 2		Under Investigation by firm
ActionAn URGENT MEDICAL DEVICE CORRECTIVE ACTION notice was sent to consignees 1/6/2026. Consignees are instructed to ensure all personnel are familiar with the contents of the notification. Users are to adhere to the Inspection and Testing and Caution sections of the IFU for both the resection/inner sheath, as well as the Inspection Before Each Use section in the Resectoscope System Manual. Additional instructions include having an extra resection sheath and inspect during and after procedure for device fragments. Consignees are to retain a copy of the notification with the IFU. Consignees with any questions may contact Cynthia Ow at Cynthia.Ow@Olympus.com or by phone at 947-999-3203.
Quantity in Commerce0 units
DistributionUS Nationwide Distribution.
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 = FJL
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