Olympus Resection Sheath Recall: Ceramic Tip Breakage Risk

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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 8mm resection sheaths (model A42011A) for gynecological use because ceramic tips have broken in complaints. This could lead to injury during medical procedures if the broken piece causes damage.

Why it’s dangerous

The ceramic tip of the resection sheath can break during use, potentially causing injury to the patient or medical staff. This breakage may occur during gynecological procedures and could lead to complications if the broken piece causes damage.

Who’s affected

Gynecologists and medical professionals using the Olympus Resection Sheath model A42011A for procedures are most at risk. Patients undergoing these procedures may also be affected if the sheath breaks during use.

How to tell if you have this one

Check for the model number A42011A on the sheath. The product was sold with a unique device identifier (UDI) starting with 04042761023658. All lots of this model are affected.

Brand
Olympus
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Verify the model number A42011A and UDI starting with 04042761023658 on the sheath.

✎ GovInfoNow

Questions people ask

Why is this sheath being recalled?

Olympus has received complaints about the ceramic tip breaking, which could cause injury during gynecological procedures.

Is there a fix for this issue?

The recall record does not mention a remedy or fix for the broken ceramic tip.

How can I tell if I have the recalled sheath?

Look for the model number A42011A and a unique device identifier (UDI) starting with 04042761023658.

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-1448-2026 — Olympus Olympus

Hello,

I own a Olympus that is covered by recall Z-1448-2026 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-1448-2026 (November 11, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1448-2026 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 Resection Sheath, 8 mm. Model No. A42011A. Resection sheath for gynecological applications.

Use caution until it’s fixed