Olympus recalls Single Use 3-Lumen Sphincterotome V (model KD-V411M-0720) due to potential deformation if not properly thermoformed, which may affect medical use.
Devices which did not undergo thermoforming could deform and lose performance.
Olympus is recalling its Single Use 3-Lumen Sphincterotome V (model KD-V411M-0720) because some units might deform if not properly thermoformed, potentially affecting medical performance. This recall affects medical professionals using the device during procedures.
The device may deform if not properly thermoformed, which could lead to reduced performance during medical procedures. This deformation might affect the device's ability to function correctly when used with an endoscope and guidewire.
Medical professionals who use this device during endoscopic procedures are most at risk. The recall applies to all units sold with the model number KD-V411M-0720.
Check for the model number KD-V411M-0720 on the device. This product was sold with a valid expiration date and is designed for use with Olympus endoscopes.
Look for the model number KD-V411M-0720 on the device to confirm if it is recalled.
The device is safe if properly thermoformed, but some units may deform and lose performance if not thermoformed correctly.
The official recall does not specify a remedy, so contact Olympus directly for guidance.
Check for the model number KD-V411M-0720 on the device; this is the only model recalled.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1272-2026 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1272-2026 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.
