Olympus recalls single-use sphincterotome devices that may deform and lose performance if not properly thermoformed. Affected models include KD-VC411Q-0330. No remedy specified in official 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 they didn't undergo proper thermoforming. This risk affects medical devices used during endoscopic procedures.
The devices require thermoforming to maintain proper shape and function. If not thermoformed correctly, they may deform and lose performance during medical procedures.
Medical professionals using these devices for endoscopic procedures are most at risk. Patients receiving the procedure may be affected if the device deforms during use.
Check for model number KD-VC411Q-0330 on the device. These devices were sold with valid expiration dates and are used with Olympus endoscopes for papillotomy procedures.
Look for model number KD-VC411Q-0330 on the device packaging or label.
The devices could deform and lose performance if they did not undergo proper thermoforming.
The official recall notice does not specify a remedy or action for affected devices.
The recall describes a risk of deformation and performance loss, but does not mention serious injury or death.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1281-2026 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1281-2026 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.
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