Brand Name: UroPass Ureteral Access Sheaths Product Name: Ureteral… — Class II medical device recall Z-0364-2025
Ongoing recall by Olympus Corporation of the Americas, reported 2024-11-20, distributed nationwide. Exposure of the UroPass product to Ultraviolet ( UV ) Radiation can cause brittleness of the device dilator ti
| Recall number | Z-0364-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Olympus Corporation of the Americas, Center Valley, PA, United States |
| Recall initiated | 2024-09-11 |
| Classified | 2024-11-12 |
| Reported by FDA | 2024-11-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CN, DE, HK, JP, KR, SG |
| Quantity | 14,093 units |
| UPC / GTIN / UDI-DI | 00821925035317, 00821925035324, 00821925035331, 00821925035348, 00821925035355, 00821925035362, 00821925035379, 00821925035386, 00821925035393, 00821925035409, 00821925035416, 00821925035423, 00821925035430, 00821925035447, 00821925035454, 00821925035461 |
| Model numbers | 61024BX, 61038BX, 61046BX, 61054BX, 61124BX, 61138BX, 61146BX, 61154BX, 61224BX, 61238BX, 61246BX, 61254BX, 61324BX, 61338BX, 61346BX, 61354BX |
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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0364-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.