Recall Z-1453-2026
Olympus Corporation of the Americas · initiated November 11, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Olympus Inner Sheath 21 Fr. Model No. A2660T. for endoscopic diagnosis and treatment in urological applications.
Codes / lots: Model No. A2660T; UDI: 04042761004183; All Lots.
Reason for recall
Complaints of the ceramic tip of the resection sheath breaking have been received.
FDA-determined 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.
Details
- Recall number
- Z-1453-2026
- Initiated
- November 11, 2025
- Posted by FDA
- February 20, 2026
- Product code
- FJL – Resectoscope
- Quantity
- 1 unit
- Distribution
- US Nationwide Distribution.
- Recalling firm
- Olympus Corporation of the Americas, Center Valley, PA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1438-2026 Class II | Olympus Resection Sheath. Model No. A22014A and A22014T. for endoscopic diagnosis and…Complaints of the ceramic tip of the resection sheath breaking have been received. | 11/11/2025Open, Classified |
| Z-1439-2026 Class II | Olympus Resection Inner Sheath, for 26 Fr. Outer Sheath. Model No. A22040A. Resection…Complaints of the ceramic tip of the resection sheath breaking have been received. | 11/11/2025Open, Classified |
| Z-1440-2026 Class II | Olympus Resection Inner Sheath for 26 Fr. Outer Sheath. Model No. A22040T. Resection…Complaints of the ceramic tip of the resection sheath breaking have been received. | 11/11/2025Open, Classified |
| Z-1441-2026 Class II | Olympus Resection Sheath, 24 Fr; Model No. A22041A. Resection sheath for urologic…Complaints of the ceramic tip of the resection sheath breaking have been received. | 11/11/2025Open, Classified |
| Z-1442-2026 Class II | Olympus Resection Sheath, 24 Fr., with Deflecting Obturator; Model No. A22041T.…Complaints of the ceramic tip of the resection sheath breaking have been received. | 11/11/2025Open, Classified |
| Z-1443-2026 Class II | Olympus Resection Sheath, 26 Fr.; Model No. A22042A. Resection sheath for urologic…Complaints of the ceramic tip of the resection sheath breaking have been received. | 11/11/2025Open, Classified |
| Z-1444-2026 Class II | Olympus Resection Sheath, 26 Fr. with Deflecting Obturator; Model No. A22042T. Resection…Complaints of the ceramic tip of the resection sheath breaking have been received. | 11/11/2025Open, Classified |
| Z-1445-2026 Class II | Olympus Resection Sheath, 28 Fr.; Model No. A22043A. Resection sheath for urologic…Complaints of the ceramic tip of the resection sheath breaking have been received. | 11/11/2025Open, Classified |
| Z-1446-2026 Class II | Olympus Resection Sheath, 28 Fr. with Deflecting Obturator. Model No. A22043T. Resection…Complaints of the ceramic tip of the resection sheath breaking have been received. | 11/11/2025Open, Classified |
| Z-1447-2026 Class II | Olympus Inner Sheath; Model No. A2660. for endoscopic diagnosis and treatment in…Complaints of the ceramic tip of the resection sheath breaking have been received. | 11/11/2025Open, Classified |
| Z-1448-2026 Class II | Olympus Resection Sheath, 8 mm. Model No. A42011A. Resection sheath for gynecological…Complaints of the ceramic tip of the resection sheath breaking have been received. | 11/11/2025Open, Classified |
| Z-1449-2026 Class II | Olympus Inner Sheath. Model No. A4741. for endoscopic diagnosis and treatment in…Complaints of the ceramic tip of the resection sheath breaking have been received. | 11/11/2025Open, Classified |
| Z-1450-2026 Class II | Olympus Inner Sheath, Long; Model No. WA22017A. Inner sheath for urological and…Complaints of the ceramic tip of the resection sheath breaking have been received. | 11/11/2025Open, Classified |
| Z-1451-2026 Class II | Olympus Inner Sheath, Long; Model No. WA22017T. Inner sheath for urological and…Complaints of the ceramic tip of the resection sheath breaking have been received. | 11/11/2025Open, Classified |
| Z-1452-2026 Class II | Olympus Resection Sheath; Model No. A2666. Resection sheath for urologic applications.Complaints of the ceramic tip of the resection sheath breaking have been received. | 11/11/2025Open, Classified |
| Z-1454-2026 Class II | Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatment in…Complaints of the ceramic tip of the resection sheath breaking have been received. | 11/11/2025Open, Classified |
| Z-1455-2026 Class II | Olympus Inner Sheath. Model No. A2641. for endoscopic diagnosis and treatment in…Complaints of the ceramic tip of the resection sheath breaking have been received. | 11/11/2025Open, Classified |
| Z-1456-2026 Class II | Olympus Inner Sheath. Model No. A2642. for endoscopic diagnosis and treatment in…Complaints of the ceramic tip of the resection sheath breaking have been received. | 11/11/2025Open, Classified |
| Z-1457-2026 Class II | Olympus Resection Sheath. Model No. A2666T. for endoscopic diagnosis and treatment in…Complaints of the ceramic tip of the resection sheath breaking have been received. | 11/11/2025Open, Classified |