FDA-Device2026-03-04Class IIPROCESSING DEFECT
Olympus Resection Sheath 28 Fr. recalled for ceramic tip breaking
OTHERNationwide distribution
Stop using Olympus Resection Sheath 28 Fr.
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)
Hazard
Complaints of the ceramic tip of the resection sheath breaking have been received.
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 Corporation of the Americas recalls
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- FDA-Device2026-04-01Olympus PKS Cutting Forceps recalled for defective welds causing jaw breakage
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