Olympus recalls Single Use 3-Lumen Sphincterotome V (KD-VC433Q-0730) due to potential deformation from improper thermoforming, risking loss of performance during medical procedures.
Devices which did not undergo thermoforming could deform and lose performance.
Olympus is recalling single-use sphincterotome surgical tools that might deform if not properly thermoformed, which could lead to reduced effectiveness during medical procedures. This affects doctors and surgical teams using these instruments.
The device may deform if it did not undergo proper thermoforming, which could cause it to lose performance during medical procedures. This means the tool might not function correctly when used with an endoscope and guidewire for papillotomy.
Medical professionals using the Olympus Single Use 3-Lumen Sphincterotome V (model KD-VC433Q-0730) for procedures like papillotomy. Patients are not directly affected as the device is used by healthcare providers.
Check for the model number KD-VC433Q-0730 on the device. The product was sold with a valid expiration date and includes specific material references.
Look for the model number KD-VC433Q-0730 on the device to confirm if it is recalled.
The device may deform if it did not undergo proper thermoforming, which could cause it to lose performance during medical procedures.
Check for the model number KD-VC433Q-0730 on the device. The product was sold with a valid expiration date and includes specific material references.
The recall does not specify a remedy, so contact Olympus directly for guidance.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1284-2026 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1284-2026 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.
