Olympus recalls Single Use 3-Lumen Sphincterotome V model KD-V411M-0725 due to potential deformation if not properly thermoformed, risking loss of performance during medical procedures.
Devices which did not undergo thermoforming could deform and lose performance.
Olymp: Olympus recalls a specific medical device (Single Use 3-Lumen Sphincterotome V model KD-V411M-0725) because some units may deform and lose performance if not properly thermoformed. This could affect medical procedures requiring precise instrument function.
The device may deform and lose performance if it did not undergo proper thermoforming. This could lead to improper function during medical procedures like papillotomy using high-frequency current.
Medical professionals using this device for endoscopic procedures are most at risk. Patients receiving the procedure may be affected if the device malfunctions.
Check for model number KD-V411M-0725 on the device. The product was sold with valid expiration dates and is used with Olympus endoscopes and guidewires for papillotomy procedures.
Look for model number KD-V411M-0725 on the device to confirm if it is recalled.
The recall indicates some units may deform and lose performance if not properly thermoformed, so it is not recommended for use without verification.
Check the model number to see if it is recalled; if yes, contact Olympus for guidance.
This device is designed for use with an Olympus endoscope and guidewire to perform papillotomy using high-frequency current.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1273-2026 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1273-2026 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.
