Recall Z-1446-2026 ยท FJL Resectoscope
Olympus Corporation of the Americas
Olympus Resection Sheath, 28 Fr. with Deflecting Obturator. Model No. A22043T. Resection sheath for urologic applications.
| Date | Feb 20, 2026 (initiated Nov 11, 2025) |
| Status | Open, Classified |
| Reason | Complaints of the ceramic tip of the resection sheath breaking have been received. |
| Root cause | Under Investigation by firm |
| Action | 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 |
| Quantity | 207 units |
| Distribution | US Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K931995 | RESECTOSCOPE SHEATH Olympus Corp., Jul 23, 1993 |