FDA-Device2026-03-04Class IIPROCESSING DEFECT
Olympus Resection Sheath Model A22042T recalled for ceramic tip breaking
What this means
Olympus Corporation of the Americas is recalling the Resection Sheath 26 Fr. with Deflecting Obturator (Model A22042T), a medical device used in urologic procedures. The ceramic tip on this device can break during use, which may affect the procedure or patient safety.
- Stop using the Olympus Resection Sheath Model A22042T immediately.
- Contact your hospital or surgical facility if you have this device in stock.
- Check your equipment inventory for Model No. A22042T and UDI 04042761020992.
- Report any incidents or injuries to Olympus at 1-888-352-6387 or the FDA.
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
1,634 units
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
Olympus Resection Sheath, 26 Fr. with Deflecting Obturator; Model No. A22042T. Resection sheath for urologic applications.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1444-2026More 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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