Olympus Single Use Sphincterotome V: Deformation Risk in Medical Procedures

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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 single-use sphincterotome devices that could deform and lose performance if they didn't undergo proper thermoforming. This might affect medical procedures during endoscopic papillotomy.

Why it’s dangerous

The devices require thermoforming to maintain proper shape and function. If not thermoformed correctly, they could deform and lose performance during medical procedures, potentially affecting the outcome.

Who’s affected

Medical professionals using the Olympus Single Use Sphincterotome V (Distal Wire guided) model KD-VC431Q-0720 for endoscopic procedures are most at risk. Patients receiving these procedures may also be affected.

How to tell if you have this one

Check for the model number KD-VC431Q-0720 on the device. These products were sold with a valid expiration date and are 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 Device Condition
Inspect the device for signs of deformation or improper shape after use.

✎ GovInfoNow

Questions people ask

What is the specific model number of the recalled device?

The recalled model is KD-VC431Q-0720.

How can I tell if my device is affected?

Look for the model number KD-VC431Q-0720 on the device, which was sold with a valid expiration date for endoscopic papillotomy procedures.

What should I do if I have the recalled device?

The recall does not specify a remedy, so check the device for deformation and contact Olympus if you have concerns.

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-1269-2026 — Olympus Olympus

Hello,

I own a Olympus that is covered by recall Z-1269-2026 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-1269-2026 (January 7, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1269-2026 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: Single Use Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC431Q-0720 Product

Lower-risk recall