FDA-Device2026-03-04Class II
Olympus Resection Sheath, 8 mm. Model No. A42011A. Resection sheath for gynecological 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
899 units
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
Olympus Resection Sheath, 8 mm. Model No. A42011A. Resection sheath for gynecological applications.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1448-2026Original summary
Olympus Resection Sheath, 8 mm. Model No. A42011A. Resection sheath for gynecological applications. Complaints of the ceramic tip of the resection sheath breaking have been received. Model No. A42011A; UDI: 04042761023658; All Lots. Distribution: US Nationwide Distribution. Affected quantity: 899 units
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