Olympus recalls single-use sphincterotome devices that may deform and lose performance if not properly thermoformed. Affected models include KD-V411M-1520 with valid expiration dates.
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 they didn't undergo proper thermoforming. This risk affects medical procedures where precise instrument function is critical.
The devices require thermoforming to maintain proper shape and function. Without this process, they may deform during use, potentially losing performance in critical medical procedures.
Healthcare professionals using these devices for medical procedures are most at risk. Patients undergoing sphincterotome procedures with affected instruments may experience reduced effectiveness.
Check for model number KD-V411M-1520 on the device. These instruments were sold with valid expiration dates and used with Olympus endoscopes for papillotomy procedures.
Look for model number KD-V411M-1520 on the device packaging or instrument itself.
The devices may deform and lose performance if they did not undergo proper thermoforming.
The recall record does not specify a remedy or action for affected devices.
The recall indicates potential performance issues if the device did not undergo thermoforming, but no specific safety concerns are described.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1290-2026 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1290-2026 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.
