Olympus Inner Sheath. Model No. A4741. for endoscopic diagnosis and treatment in gynecological applications.
Recall
- Recall Number
- Z-1449-2026
- Event Number
- 98288
- Firm
- Olympus Corporation of the Americas
- FEI Number
- 2429304
- Product Code
- HIH
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- November 11, 2025
- Posted
- February 20, 2026
- Address
- 3500 Corporate Pkwy, Center Valley, PA, 18034-8229
Description
Olympus Inner Sheath. Model No. A4741. for endoscopic diagnosis and treatment in gynecological applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
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 [email protected] or by phone at 947-999-3203.
US Nationwide Distribution.
91 units