Olympus recalls disposable triple lumen sphincterotomes (model KD-401Q-0330) 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-0330) that could deform and lose performance if they didn't undergo proper thermoforming. This could affect medical procedures using the device.
The device may deform and lose performance if it didn't undergo proper thermoforming. This could affect its function during medical procedures like papillotomy using high-frequency current.
Medical professionals using the device for endoscopic procedures are most likely affected. Patients undergoing papillotomy procedures with this device may be at risk if the instrument deforms.
Check for model number KD-401Q-0330 on the device. The product was sold with valid expiration dates and used with Olympus endoscopes for papillotomy procedures.
Look for model number KD-401Q-0330 on the disposable triple lumen sphincterotome.
The devices may deform and lose performance if they did not undergo proper thermoforming.
The recall record does not specify any remedy actions.
The recall indicates potential deformation and performance loss if not properly thermoformed, but no specific safety concerns are stated.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1287-2026 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1287-2026 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.
