Olympus recalls single-use sphincterotome devices that may deform if not properly thermoformed, risking reduced performance 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 they didn't undergo proper thermoforming. This could affect the device's effectiveness during medical procedures.
The devices require thermoforming to maintain proper shape and function. If not thermoformed correctly, they may deform and lose performance during use, potentially affecting the procedure's effectiveness.
Medical professionals using these devices for endoscopic procedures are most at risk. Patients receiving the procedure may be affected if the device doesn't function as intended.
Check for model number KD-VC411Q-0730 on the device. These were sold with valid expiration dates and used with Olympus endoscopes for papillotomy procedures.
Look for model number KD-VC411Q-0730 on the device label.
The devices could deform and lose performance if they did not undergo proper thermoforming, potentially affecting their effectiveness during medical procedures.
The recall record does not specify a remedy or action for affected devices.
The recall indicates a risk of reduced performance, but no specific injury mechanism is described.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1279-2026 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1279-2026 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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