FDA-Device2026-03-04Class IIPROCESSING DEFECT
Olympus Resection Sheath 26 Fr. recalled for ceramic tip breaking hazard
What this means
Olympus has recalled its Resection Sheath 26 Fr. (Model A22042A) used in urologic procedures because the ceramic tip can break during use. The company has received complaints about this defect. All lots of this device are affected.
- Stop using Model A22042A immediately if you have this device in stock
- Contact your Olympus representative or call the company for return or replacement instructions
- Review any procedures performed with this sheath and consult your supervisor or medical director if needed
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
1,676 units
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
Olympus Resection Sheath, 26 Fr.; Model No. A22042A. Resection sheath for urologic applications.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1443-2026More Olympus recalls
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- FDA-Device2026-07-29Olympus High Flow Insufflation Unit UHI-4 recalled for unexpected display shutdown and air delivery loss
- 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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