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FDASeptember 11, 2024device

Brand Name: UroPass Ureteral Access Sheaths Product Name: Ureteral Access Sheaths Model/Catalog Number: 61024BX, 61038BX, 61046BX, 61054BX, 61124BX, 61138BX, 61146BX, 61154BX, 61224BX, 61238BX, 61246BX, 61254BX, 61324BX, 61338BX, 61346BX, 61354BX Software Version: N/A Product Description: The Oly...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Exposure of the UroPass product to Ultraviolet ( UV ) Radiation can cause brittleness of the device dilator tip, which may lead to broken dilator tips in the package or in patients during surgical procedures.

What to do

FDA enforcement status: Ongoing

Brands named

olympus

UPCs

008219250353170082192503532400821925035331008219250353480082192503535500821925035362008219250353790082192503538600821925035393008219250354090082192503541600821925035423

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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