Olympus recalls single-use sphincterotome devices that may deform if not properly thermoformed, potentially affecting medical procedures. Affected models include KD-VC431Q-0720.
Devices which did not undergo thermoforming could deform and lose performance.
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.
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.
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.
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.
Inspect the device for signs of deformation or improper shape after use.
The recalled model is KD-VC431Q-0720.
Look for the model number KD-VC431Q-0720 on the device, which was sold with a valid expiration date for endoscopic papillotomy procedures.
The recall does not specify a remedy, so check the device for deformation and contact Olympus if you have concerns.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
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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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.
