Olympus recalls Single Use 3-Lumen Sphincterotome V (model KD-V431M-0730) due to potential deformation if not properly thermoformed, affecting medical use safety.
Devices which did not undergo thermoforming could deform and lose performance.
Olympus is recalling its Single Use 3-Lumen Sphincterotome V model KD-V431M-0730 because some units may deform and lose performance if not correctly thermoformed. This could impact medical procedures requiring precise instrument function.
The device requires thermoforming to maintain shape and function. If not properly thermoformed, it may deform and lose performance, potentially causing inaccurate medical procedures.
Medical professionals using this instrument for endoscopic procedures are most at risk. Patients undergoing papillotomy may be affected if the instrument deforms during use.
Check for model number KD-V431M-0730 on the instrument. This product was sold with valid expiration dates and used with Olympus endoscopes for papillotomy procedures.
Verify the model number on the instrument to confirm it matches KD-V431M-0730.
The product may deform and lose performance if not properly thermoformed, which could affect medical procedure accuracy.
The recall does not specify a remedy, so contact Olympus directly for guidance.
The recall indicates potential performance issues but does not mention injury risks, so the risk level is low.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1276-2026 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1276-2026 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.
