Olympus recalls single-use sphincterotome v (model KD-V411M-3030) that may deform if not properly thermoformed, risking reduced performance during medical procedures.
Devices which did not undergo thermoforming could deform and lose performance.
Olympus is recalling single-use sphincterotome v instruments (model KD-V411M-3030) that could deform and lose performance if not properly thermoformed. This affects medical devices used during endoscopic procedures. The recall is important because improper use could lead to ineffective treatment outcomes.
The instruments may deform if not properly thermoformed during manufacturing, which could lead to reduced performance during medical procedures. This might result in ineffective treatment outcomes if the device does not function as intended.
Medical professionals using Olympus single-use sphincterotome v instruments (model KD-V411M-3030) for endoscopic procedures are most affected. Patients receiving these instruments during papillotomy procedures may be impacted.
Check for model number KD-V411M-3030 on the instrument. These devices were sold with valid expiration dates and are used with Olympus endoscopes for papillotomy procedures.
Verify the model number on the instrument to confirm it is KD-V411M-3030.
The instruments may deform if not properly thermoformed, which could lead to reduced performance during medical procedures.
The official recall notice does not specify a remedy or action steps for affected products.
The recall describes a risk of reduced performance, not injury. The hazard does not mention physical harm.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1292-2026 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1292-2026 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.
