FDA-Device2026-03-04Class II
Olympus Resection Inner Sheath for 26 Fr. Outer Sheath. Model No. A22040T. Resection sheath for urologic applications.
Olympus Corporation of the Americas
Hazard
Complaints of the ceramic tip of the resection sheath breaking have been received.
Sold states
US Nationwide Distribution.
Affected count
7,426 units
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
Olympus Resection Inner Sheath for 26 Fr. Outer Sheath. Model No. A22040T. Resection sheath for urologic applications.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1440-2026Original summary
Olympus Resection Inner Sheath for 26 Fr. Outer Sheath. Model No. A22040T. Resection sheath for urologic applications. Complaints of the ceramic tip of the resection sheath breaking have been received. Model No. A22040T; UDI: 04042761029360; All Lots. Distribution: US Nationwide Distribution. Affected quantity: 7,426 units
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