FDA-Device2026-03-04Class IIPROCESSING DEFECT

Olympus Resection Inner Sheath Model A22040T recalled for ceramic tip fracture risk

OTHERNationwide distribution

Stop using Olympus Resection Inner Sheath A22040T

Olympus has recalled a urologic resection sheath (Model A22040T) because the ceramic tip can break during use. The FDA has classified this as a Class II recall, meaning the defect could cause serious harm. No injuries have been reported so far.

  • Stop using Model A22040T immediately if you have it in your facility
  • Contact Olympus Corporation of the Americas for a replacement or return instructions
  • Check your inventory for all lots of this model—all production lots are affected
Hazard

Complaints of the ceramic tip of the resection sheath breaking have been received.

Sold states
US Nationwide Distribution.
Affected count
7,426 units
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
Olympus Resection Inner Sheath for 26 Fr. Outer Sheath. Model No. A22040T. Resection sheath for urologic applications.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1440-2026

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