FDA-Device2026-03-04Class IIPROCESSING DEFECT
Olympus Resection Sheath Model A22041T recalled for ceramic tip breakage
OTHERNationwide distribution
Stop using Olympus Resection Sheath Model A22041T
Olympus is recalling a urologic resection sheath because the ceramic tip can break during use. This affects Model No. A22041T units distributed nationwide. No injuries have been reported, but a broken tip could affect the device's function.
- Stop using this device immediately if you have it in your facility
- Contact Olympus or your supplier for instructions on return or replacement
- Check your inventory for Model No. A22041T (UDI: 04042761020978)
Hazard
Complaints of the ceramic tip of the resection sheath breaking have been received.
Sold states
US Nationwide Distribution.
Affected count
2,626 units
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
Olympus Resection Sheath, 24 Fr., with Deflecting Obturator; Model No. A22041T. Resection sheath for urologic applications.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1442-2026More Olympus Corporation of the Americas recalls
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- FDA-Device2026-07-22Olympus Ellik Evacuator Model 194 recalled for inadequate sterilization parameters
- FDA-Device2026-07-22Olympus Toomey Evacuator 30cc with Adaptor recalled for inadequate sterilization
- FDA-Device2026-07-22Olympus Glass Body for 194 Ellik Evacuator recalled for inadequate sterilization
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