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Official recall record

Uropass Ureteral Access Sheath

Health Canada — Medical Devices · 2024-10-18 · CanadaType II
Issuing authority
Health Canada — Medical Devices
Published
2024-10-18
Country of alert
Canada
Alert level
Type II
Alert type
recall

What the authority reported

Olympus conducted an investigation after receiving complaints reporting broken dilator tips in the package and in patients during surgical procedures. The investigation determined that exposing the Uropass product to ultraviolet ("UV") radiation can cause brittleness of the device dilator tip, which may lead to breakage. Since April 2023, Olympus has received 2 adverse event complaints reporting broken Uropass dilator tips for devices still within their shelf life. Recall start date: October 4, 2024

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

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