Olympus Corporation of the Americas: Device Recall

Recall #Z-0364-2025 · 09/11/2024

Class II: Risk

Recall Details

Recall Number
Z-0364-2025
Classification
Class II
Product Type
Device
Recalling Firm
Olympus Corporation of the Americas
Status
Ongoing
Date Initiated
09/11/2024
Location
Center Valley, PA, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
14,093 units

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.

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

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Australia, Canada, China, Germany, Hong Kong, Japan, Republic of South Korea, Singapore.

Other Recalls by Olympus Corporation of the Americas

View all recalls by Olympus Corporation of the Americas →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.