Olympus recalls single-use sphincterotome devices that may deform and lose performance if not properly thermoformed. Affected models include KD-VC411Q-0725. No remedy specified in recall notice.
Devices which did not undergo thermoforming could deform and lose performance.
Olympus is recalling single-use sphincterotome devices that could deform and lose performance if not properly thermoformed. This affects medical devices used during endoscopic procedures. The recall is for specific model numbers and does not include software versions.
The devices may deform and lose performance if they did not undergo proper thermoforming. This could affect their function during endoscopic procedures but does not pose a direct risk of injury in normal use.
Medical professionals using the Olympus Single Use 3-Lumen Sphincterotome V (model KD-VC411Q-0725) for endoscopic procedures. Patients receiving these devices during surgery are at minimal risk if the device was properly thermoformed.
Check for model number KD-VC411Q-0725 on the device. These are single-use instruments designed for endoscopic papillotomy procedures. The recall applies to all lots with valid expiration dates.
Look for model number KD-VC411Q-0725 on the device packaging or label.
The recall notice states software version is N/A (not applicable).
The recall notice does not specify a remedy or return process.
The device may lose performance if not properly thermoformed, but the recall does not indicate this causes injury.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1297-2026 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1297-2026 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.
