FDA-Device2026-03-04Class IIPROCESSING DEFECT
Olympus Resection Inner Sheath Model A22040T recalled for ceramic tip fracture risk
What this means
Olympus has recalled a urologic resection sheath (Model A22040T) because the ceramic tip can break during use. The FDA has classified this as a Class II recall, meaning the defect could cause serious harm. No injuries have been reported so far.
- Stop using Model A22040T immediately if you have it in your facility
- Contact Olympus Corporation of the Americas for a replacement or return instructions
- Check your inventory for all lots of this model—all production lots are affected
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
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-1440-2026More Olympus recalls
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- FDA-Device2026-07-22Olympus Toomey Evacuator 50cc Model 188A recalled for inadequate sterilization parameters
- FDA-Device2026-07-22Olympus Glass Body for 194 Ellik Evacuator recalled for inadequate sterilization
- FDA-Device2026-07-22Olympus Toomey Evacuator 30cc with Adaptor recalled for inadequate sterilization
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