Z-0364-2025 Class II Ongoing
FDA device recall Z-0364-2025 was initiated by Olympus Corporation of the Americas on September 11, 2024 and is designated Class II. Reason for recall: 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 pro… The recall status is ongoing. Affected quantity: 14,093 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 20, 2024
- Initiation Date
- September 11, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14,093 units
Product Description
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
Reason for Recall
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.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Australia, Canada, China, Germany, Hong Kong, Japan, Republic of South Korea, Singapore.
Code Information
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.