Olympus recalls Single Use 3-Lumen Sphincterotome V (model KD-V431M-0720) due to potential deformation if not properly thermoformed, affecting surgical use.
Devices which did not undergo thermoforming could deform and lose performance.
Olympus is recalling its Single Use 3-Lumen Sphincterotome V model KD-V431M-0720 because some units may deform and lose performance if not correctly thermoformed. This could impact surgical procedures requiring precise instrument function.
The instruments require proper thermoforming to maintain their shape and function. If not thermoformed correctly, they may deform and lose performance during surgical use, potentially affecting procedure accuracy.
Surgical professionals using the Olympus Single Use 3-Lumen Sphincterotome V model KD-V431M-0720 for endoscopic procedures are most at risk. Patients and healthcare facilities using this specific model may be affected.
Check for the model number KD-V431M-0720 on the instrument. This product was sold with a valid expiration date and is used with Olympus endoscopes for papillotomy procedures.
Verify the model number on the instrument to confirm it is KD-V431M-0720.
The instruments may deform and lose performance if not properly thermoformed, which could affect surgical procedures.
The recall record does not specify a remedy, so no action is required beyond checking the model number.
The product is safe if properly thermoformed, but some units may deform and lose performance.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1275-2026 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1275-2026 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.
