FDA-Device2026-03-04Class IIPROCESSING DEFECT
Olympus Inner Sheath WA22017A recalled for ceramic tip breakage risk
What this means
Olympus has recalled its Inner Sheath Long (Model WA22017A), a medical device used in urological and gynecological procedures. The ceramic tip on the resection sheath can break during use. The FDA has classified this as a Class II recall affecting 437 units distributed nationwide.
- Stop using Model WA22017A immediately if you have this device
- Contact Olympus Corporation of the Americas for instructions on return or replacement
- Review your inventory for all lots of this model number
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
437 units
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
Olympus Inner Sheath, Long; Model No. WA22017A. Inner sheath for urological and gynecological applications.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1450-2026More Olympus recalls
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- 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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