FDAFDA · Food and drugs·Recall number Z-0364-2025
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 Olympus UroPass Ureteral Access Sheath Set consists of a hydrophilic coated outer sheath and an inner tapered dilator intended to establish a conduit for the passage of endoscopes and retrieval devices into the ureter. The hydrophilic coating on the UroPass Ureteral Access Sheath eases passage and placement. Both the outer sheath and inner dilator are radio-opaque for ease of viewing radiographically. Intended for single use only. Component: N/A
Published November 20, 2024 · Recall initiated: September 11, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Olympus Corporation of the Americas
- Distributor
- Worldwide distribution - US Nationwide and the countries of Australia, Canada, China, Germany, Hong Kong, Japan, Republic of South Korea, Singapore.
- Lot
- Model/UDI-DI: 61024BX/00821925035317, 61038BX/00821925035324, 61046BX/00821925035331, 61054BX/00821925035348, 61124BX/00821925035355, 61138BX/00821925035362, 61146BX/00821925035379, 61154BX/00821925035386, 61224BX/00821925035393, 61238BX/00821925035409, 61246BX/00821925035416, 61254BX/00821925035423, 61324BX/00821925035430, 61338BX/00821925035447, 61346BX/00821925035454, 61354BX/00821925035461.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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