FDA-Device2026-03-04Class II
Olympus Inner Sheath, Long; Model No. WA22017A. Inner sheath for urological and 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
437 units
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
Olympus Inner Sheath, Long; Model No. WA22017A. Inner sheath for urological and gynecological applications.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1450-2026Original summary
Olympus Inner Sheath, Long; Model No. WA22017A. Inner sheath for urological and gynecological applications. Complaints of the ceramic tip of the resection sheath breaking have been received. Model No. WA22017A; UDI: 04042761051514; All Lots. Distribution: US Nationwide Distribution. Affected quantity: 437 units
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