Olympus A2641 Inner Sheath Recall: Ceramic Tip Breakage Risk

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Contact the company & request your remedy

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

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Olympus is recalling its A2641 Inner Sheath for urological endoscopy procedures because ceramic tips have broken. This could lead to complications during medical procedures if the sheath fails unexpectedly.

Why it’s dangerous

The ceramic tip of the sheath can break during use, potentially causing complications in urological procedures. This breakage may lead to unexpected sheath failure during endoscopic treatments.

Who’s affected

Urology doctors and medical staff using the Olympus A2641 Inner Sheath for endoscopic procedures are affected. Patients undergoing urological treatments with this device may be at risk if the sheath breaks during use.

How to tell if you have this one

Check for the model number A2641 on the sheath. All lots with the unique device identifier (UDI) 04042761004060 are affected.

Brand
Olympus
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Model
Verify the model number on the sheath is A2641.
Contact Manufacturer
Reach out to Olympus Corporation of the Americas for further assistance.

✎ GovInfoNow

Questions people ask

Is this recall affecting patients directly?

The recall affects medical staff using the device, but patients are not directly affected unless the device breaks during their procedure.

How can I tell if I have the recalled model?

Look for the model number A2641 and the unique device identifier (UDI) 04042761004060 on the sheath.

What should I do if I have the recalled sheath?

Contact Olympus Corporation of the Americas for guidance on next steps.

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-1455-2026 — Olympus Olympus

Hello,

I own a Olympus that is covered by recall Z-1455-2026 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-1455-2026 (November 11, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1455-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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 Olympus Inner Sheath. Model No. A2641. for endoscopic diagnosis and treatment in urological applications.

Lower-risk recall