Olympus recalls single-use sphincterotome v (model KD-V411M-153: devices without proper thermoforming may deform and lose performance. Affected units sold with valid expiration dates.
Devices which did not undergo thermoforming could deform and lose performance.
Olympus is recalling single-use sphincterotome v devices that may deform and lose performance if they didn't undergo proper thermoforming. This could affect medical procedures requiring precise instrument function.
The devices require thermoforming to maintain shape and function. Without proper thermoforming, the instrument may deform and lose performance during medical procedures, potentially affecting procedure accuracy.
Medical professionals using these devices for endoscopic procedures are most at risk. Patients undergoing papillotomy procedures with this instrument could be affected if the device deforms.
Check for model number KD-V411M-1530 on the device. These units were sold with valid expiration dates and used with Olympus endoscopes for papillotomy procedures.
Look for model number KD-V411M-1530 on the device.
The devices may deform and lose performance if they did not undergo proper thermoforming.
Check for model number KD-V411M-1530 on the device. These units were sold with valid expiration dates and used with Olympus endoscopes for papillotomy procedures.
The recall record does not specify a remedy, so contact Olympus directly for guidance.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1291-2026 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1291-2026 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.
+ 1 more story
