Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall 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 Ol

U.S. FDA — Device Enforcement · United States · 2024-09-11 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0364-2025
Date of alert: 2024-09-11
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Olympus Corporation of the Americas
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00821925035317

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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