FDA-Device2026-03-04Class IIPROCESSING DEFECT
Olympus WA22017T urological sheath recalled for ceramic tip breakage
What this means
Olympus has recalled its Inner Sheath, Long (Model WA22017T) used in urological and gynecological procedures because the ceramic tip of the resection sheath can break during use. The company received multiple complaints about this defect. About 1,141 units are affected nationwide.
- Stop using Model WA22017T immediately if you have stock.
- Contact your Olympus representative or the FDA for return or replacement instructions.
- Review any procedures performed with this device and follow up with affected patients 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
1,141 units
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
Olympus Inner Sheath, Long; Model No. WA22017T. Inner sheath for urological and gynecological applications.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1451-2026More 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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