Olympus recalls disposable triple lumen sphincterotomes (model KD-411Q-0720) that may deform and lose performance if not properly thermoformed. Affected items were sold with valid expiration dates.
Devices which did not undergo thermoforming could deform and lose performance.
Olympus is recalling disposable triple lumen sphincterotomes (model KD-411Q-0720) that could 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 proper shape and function. If not properly thermoformed, they could deform and lose performance, potentially affecting medical procedures.
Medical professionals using these instruments during endoscopic procedures are most at risk. Patients undergoing papillotomy procedures with these instruments may be affected if the device deforms.
Look for the model number KD-411Q-0720 on the instrument. These were sold with valid expiration dates and used with Olympus endoscopes for papillotomy procedures.
Verify the model number on the instrument to confirm it is KD-411Q-0720.
The devices may deform and lose performance if they did not undergo proper thermoforming.
The recall does not specify a remedy, so no action is required beyond checking the model number.
The hazard is that the devices could deform and lose performance, which might affect medical procedures but does not pose a direct safety risk to users.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1285-2026 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1285-2026 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.
