Olympus Resection Sheath, 28 Fr. with Deflecting Obturator. Model No. A22043T. Resection sheath for urologic applications.
- Recall Initiated
- November 11, 2025
- Posted
- February 20, 2026
- Recall Number
- Z-1446-2026
- Quantity
- 207 units
- Firm Location
- Center Valley, PA
Reason for Recall
Complaints of the ceramic tip of the resection sheath breaking have been received.
Distribution
US Nationwide Distribution.
Lot / Code Info
Model No. A22043T; UDI: 04042761021012; All Lots.
Root Cause
Under Investigation by firm
Action Taken
An 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.