FDA-Device2026-03-04Class IIPROCESSING DEFECT

Olympus WA22017T urological sheath recalled for ceramic tip breakage

OTHERNationwide distributionMedical devices

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-1451-2026

More Olympus recalls

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