Olympus Disposable Triple Lumen Sphincterotome Recall: Deformation Risk

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

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Olympus is recalling disposable triple lumen sphincterotomes with model number KD-401Q-0720 because some units may deform and lose performance if they didn't undergo proper thermoforming. This could affect medical procedures requiring precise instrument function.

Why it’s dangerous

The devices may deform and lose performance if they did not undergo proper thermoforming. This could lead to improper function during medical procedures requiring high-frequency current for papillotomy.

Who’s affected

Medical professionals using these instruments during endoscopic procedures are most at risk. Patients undergoing papillotomy procedures with this device could be affected if the instrument deforms.

How to tell if you have this one

Check for model number KD-401Q-0720 on the instrument. These are disposable instruments used with Olympus endoscopes for papillotomy procedures.

Brand
Olympus
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Model Number
Look for model number KD-401Q-0720 on the instrument.

✎ GovInfoNow

Questions people ask

Why is this product being recalled?

The devices may deform and lose performance if they did not undergo proper thermoforming.

What should I do if I have this product?

Check the model number on the instrument. If it matches KD-401Q-0720, stop using it and contact Olympus for further instructions.

Is there a risk of serious injury?

The recall states the devices may deform and lose performance, but does not mention risk of serious injury.

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-1288-2026 — Olympus Olympus

Hello,

I own a Olympus that is covered by recall Z-1288-2026 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-1288-2026 (January 7, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1288-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 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 Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0720 Product Description: These

Lower-risk recall