Olympus UroPass Sheaths Recall: Dilator Tips May Break During Surgery

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Recalling firmOlympus Corporation of the Americas3500 Corporate Pkwy · Center Valley, PA 18034-8229

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Olympus is recalling certain UroPass ureteral access sheaths because dilator tips can break during surgery. This poses a risk of injury to patients. Affected products were made in 2018 or 2019 and include specific model numbers.

Why it’s dangerous

Dilator tips in the sheaths can break during surgical procedures, potentially causing injury to patients. This breakage occurs both in the packaging and during use in patients.

Who’s affected

Patients undergoing urological surgery who use the recalled sheaths are most at risk. Healthcare providers who use these sheaths for procedures may also be affected.

How to tell if you have this one

Check the model numbers listed: 61024BX through 61354BX. Products manufactured in 2018 or 2019 are affected. The manufacturing date is printed on the pouch label in YYYY-MM-DD format.

Brand
Olympus
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Model Numbers
Look for model numbers 61024BX through 61354BX on the product packaging.
Verify Manufacturing Date
Confirm the product was made in 2018 or 2019 by checking the manufacturing date on the pouch label.

✎ GovInfoNow

Questions people ask

Why is this recall happening?

Dilator tips in the sheaths can break during surgical procedures, potentially causing injury to patients.

What models are affected?

Models 61024BX through 61354BX (all products manufactured in 2018 and 2019).

How can I check if my product is affected?

Check the model number on the packaging and verify the manufacturing date is in 2018 or 2019.

Take action

Contact Olympus

We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-2401-2023 — Olympus Olympus

Hello,

I own a Olympus that is covered by recall Z-2401-2023 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.

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Where this comes from

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.

Official source: FDA Recall #Z-2401-2023 (May 19, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2401-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Olympus Corporation of the Americas recalls UroPass Ureteral Access Sheaths, 5 pieces/box

Lower-risk recall