Olympus recalls Single Use 3-Lumen Sphincterotome V (KD-VC411Q-0320) due to potential deformation from improper thermoforming, risking loss of performance during medical procedures.
Devices which did not undergo thermoforming could deform and lose performance.
Olympus is recalling a single-use medical device that may deform if not properly thermoformed, which could lead to loss of function during endoscopic procedures. This affects medical professionals using the device for papillotomy.
The device may deform if it did not undergo proper thermoforming, causing it to lose performance during medical procedures. This could affect the device's ability to function correctly when used with an endoscope and guidewire for papillotomy.
Medical professionals who use the Olympus Single Use 3-Lumen Sphincterotome V (model KD-VC411Q-0320) for endoscopic procedures are most at risk. The recall applies to all units with valid expiration dates.
Check for the model number KD-VC411Q-0320 on the device. The product was sold with valid expiration dates and is designed for use with Olympus endoscopes and guidewires.
Look for the model number KD-VC411Q-0320 on the device to confirm it is affected.
The device may deform if it did not undergo proper thermoforming, which could cause it to lose performance during medical procedures.
The recall does not specify a remedy, so no action is required beyond checking the model number.
The device is safe if it underwent proper thermoforming, but the recall indicates some units may deform and lose performance.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1280-2026 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1280-2026 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
