The Recall Desk
HighFDA (Devices)·Z-1440-2026·Announced 2026-03-04

Olympus resection inner sheath recalled after ceramic tip breakage complaints

Olympus is recalling its Resection Inner Sheath for 26 Fr outer sheath, model A22040T, used in urologic applications, after complaints that the ceramic tip of the resection sheath can break.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: this is an FDA Class II recall of a device that can break during a procedure, with no injuries or hospitalisations stated in the source.

Plain-English summary

Olympus Corporation of the Americas is recalling the Olympus Resection Inner Sheath for 26 Fr outer sheath, model number A22040T, a resection sheath for urologic applications. About 7,426 units were distributed nationwide in the United States. The FDA has classified this recall as Class II.

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

All lots are affected. The device carries UDI 04042761029360.

Facilities can identify affected devices by the model number and UDI above, and may contact Olympus Corporation of the Americas for further information.

The recalled product

Product
Olympus Resection Inner Sheath for 26 Fr. Outer Sheath. Model No. A22040T. Resection sheath for urologic applications.
Manufacturer
Olympus Corporation of the Americas
Category
Medical Device — Endoscopy
Hazard
  • device-breakage
  • surgical-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Model No. A22040T
  • UDI: 04042761029360
  • All Lots.

Distribution

Distributed nationwide across the United States.

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