FDA-Device2026-03-04Class IIPROCESSING DEFECT
Olympus Resection Inner Sheath recalled for ceramic tip breaking hazard
What this means
Olympus has recalled a urologic resection sheath (Model A22040A) because the ceramic tip can break during use. The FDA has classified this as a Class II recall affecting 6,949 units distributed nationwide. No injuries have been reported.
- Stop using this device immediately if you have it in stock or use.
- Contact your Olympus representative or the company for return or replacement instructions.
- Report any device failures or injuries to the FDA MedWatch program.
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
6,949 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. A22040A. Resection sheath for urologic applications.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1439-2026More 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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