FDA-Device2026-03-04Class IIPROCESSING DEFECT
Olympus Resection Sheath 28 Fr. recalled for ceramic tip breaking
What this means
The ceramic tip on Olympus Resection Sheath model A22043A can break during use. This is a medical device used in urologic procedures. No injuries have been reported, but the broken tip could affect the device's function.
- Stop using affected Resection Sheath devices immediately
- Contact your facility's medical device coordinator or Olympus customer service for replacement or instructions
- Review your inventory for model A22043A (all lots affected)
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
118 units
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
Olympus Resection Sheath, 28 Fr.; Model No. A22043A. Resection sheath for urologic applications.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1445-2026More 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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