Olympus recalls single-use sphincterotome devices that may deform without proper thermoforming, risking loss of function during medical procedures.
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 use during endoscopic procedures and requires checking the model number for recall.
Devices that skip thermoforming may deform and fail to function properly during medical procedures. This could lead to ineffective treatment or complications during endoscopic papillotomy using high-frequency current.
Medical professionals using the Olympus Single Use 3-Lumen Sphincterotome V (model KD-VC431Q-0730) for endoscopic procedures are most at risk. Patients using these devices during papillotomy are also affected.
Check for model number KD-VC431Q-0730 on the device. The product was sold with valid expiration dates and used with Olympus endoscopes and guidewires for papillotomy.
Verify the model number on the device to confirm if it is KD-VC431Q-0730.
The devices could deform and lose performance if not properly thermoformed, which may affect their function during medical procedures.
Check the model number to see if it is KD-VC431Q-0730. If so, contact Olympus for guidance on next steps.
The recall states devices may deform and lose performance, but no specific injury risk is mentioned in the official notice.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1277-2026 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1277-2026 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
