Olympus recalls UroPass ureteral access sheaths (models 61024BX-61354BX) due to UV exposure causing brittleness and potential broken tips during surgery.
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.
Olympus is recalling UroPass ureteral access sheaths that may become brittle when exposed to UV light, risking broken tips during surgical procedures. This could lead to complications for patients needing ureteral procedures.
The hydrophilic coating on the sheaths can degrade when exposed to UV radiation, causing the dilator tip to become brittle. This brittleness may lead to broken tips either in the packaging or during surgical use, potentially causing complications for patients.
Medical professionals using the UroPass ureteral access sheaths for surgical procedures are most at risk. Patients undergoing ureteral procedures with these sheaths may face complications if tips break.
Check for model numbers 61024BX through 61354BX on the sheath packaging. These sheaths were sold with the specific model numbers listed in the recall notice.
Inspect the sheaths for signs of brittleness, such as cracks or breaks in the dilator tip.
Reach out to Olympus Corporation of the Americas for guidance on next steps if you have the recalled sheaths.
UV radiation can cause the hydrophilic coating to degrade, making the dilator tip brittle and prone to breaking during use or storage.
The recall does not specify storage conditions, so it's unclear if dark storage prevents the issue. Always check for brittleness.
Look for model numbers 61024BX through 61354BX on the sheath packaging or product labels.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0364-2025 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0364-2025 from Olympus. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
