Olympus Resection Sheath, 28 Fr. with Deflecting Obturator. Model No. A22043T. Resection sheath for urologic application
FDA device recall Z-1446-2026 · posted 2026-02-20 · Open, Classified
Recall details
- Recalling firm
- Olympus Corporation of the Americas
- Reason for recall
- Complaints of the ceramic tip of the resection sheath breaking have been received.
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- FJL
- Quantity affected
- 207 units
- Distribution
- US Nationwide Distribution.
- Date initiated
- 2025-11-11
- Date posted
- 2026-02-20
- Location
- Center Valley, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RESECTOSCOPE SHEATH (K931995) | Olympus Corp. | 1993-07-23 |