Olympus recalls disposable triple lumen sphincterotomes with model KD-411Q-0730 that may deform and lose performance if not properly thermoformed. Affected units were sold with valid expiration dates.
Devices which did not undergo thermoforming could deform and lose performance.
Olympus is recalling disposable triple lumen sphincterotomes with model number KD-411Q-0730 because some units may deform and lose performance if they didn't undergo proper thermoforming. This could affect medical procedures requiring precise instrument function.
These disposable surgical instruments are designed to be used with endoscopes and guidewires for papillotomy. If the instrument did not undergo proper thermoforming, it could deform and lose performance during use, potentially affecting the procedure's effectiveness.
Medical professionals using these instruments during endoscopic procedures are most at risk. Patients receiving these procedures may be affected if the instrument malfunctions.
Check for the model number KD-411Q-0730 on the instrument. The product was sold with valid expiration dates and is used with Olympus endoscopes for medical procedures.
Look for the model number KD-411Q-0730 on the instrument to confirm if it is affected.
The instruments may deform and lose performance if they did not undergo proper thermoforming.
Check the model number to see if it is affected; if so, contact Olympus for guidance.
The recall states the instruments could lose performance, but no specific injury risk is mentioned.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1286-2026 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1286-2026 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.
