Olympus recalls disposable triple lumen sphincterotomes (model KD-401Q-0725) 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 (model KD-401Q-0725) that could deform and lose performance if they didn't undergo proper thermoforming. This risk affects medical procedures using endoscopes and guidewires.
These disposable surgical instruments are designed to be used with endoscopes and guidewires. If they didn't undergo proper thermoforming, they could deform and lose performance during medical procedures.
Medical professionals using these instruments during endoscopic procedures are most at risk. Patients receiving the procedure may also be affected if the device malfunctions.
Check for the model number KD-401Q-0725 on the instrument. The product was sold with valid expiration dates and used with Olympus endoscopes for papillotomy procedures.
Look for the model number KD-401Q-0725 on the instrument.
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 steps for affected products.
The recall indicates that devices without proper thermoforming may lose performance, but the official notice does not specify if the product is safe to use.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1294-2026 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1294-2026 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.
