FDA-Device2026-03-04Class IIPROCESSING DEFECT
Olympus Resection Sheath Model A22041T recalled for ceramic tip breakage
What this means
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)
The agency's original wording
Hazard
Complaints of the ceramic tip of the resection sheath breaking have been received.
Intended for
Adults
Illnesses reported
None reported
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 recalls
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