Olympus recalls single-use sphincterotome devices that may deform if not properly thermoformed, risking reduced effectiveness during medical procedures. Affected models include KD-V411M-0330.
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 not properly thermoformed. This means the devices might not work correctly during medical procedures, potentially affecting treatment outcomes.
The devices require thermoforming to maintain proper shape and function. If not thermoformed correctly, they may deform and lose performance, which could lead to ineffective medical procedures.
Medical professionals using Olympus Single Use 3-Lumen Sphincterotome V (model KD-V411M-0330) for procedures like papillotomy. Patients undergoing these procedures are at risk if the device deforms during use.
Check for model number KD-V411M-0330 on the device. These products were sold with valid expiration dates and are used with Olympus endoscopes for papillotomy procedures.
Look for model number KD-V411M-0330 on the device to confirm if it is affected.
The devices may deform and lose performance if not properly thermoformed, which could affect their effectiveness during medical procedures.
Check the model number on the device. If it is KD-V411M-0330, contact Olympus for guidance on next steps.
The recall is for potential reduced effectiveness during procedures, not a direct injury risk. The hazard is low risk as it relates to device performance, not immediate harm.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1271-2026 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1271-2026 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.
