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Olympus Corporation of the Americas recalls Brand Name: UroPass Ureteral Access Sheaths Product Name: Ureteral Access Sheaths Model/Catalog Number: 61024BX, 61038
Recalled November 20, 2024 · FDA recall Z-0364-2025 · Olympus Corporation of the Americas
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. · FDA Class II
Units
14,093 units
Sold at
Worldwide distribution - US Nationwide and the countries of Australia, Canada, China, Germany, Hong Kong, Japan, Republic of South Korea, Singapore.
Description
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.
Product
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
Manufacturer(s)
Olympus Corporation of the Americas
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →