Olympus recalls disposable triple lumen sphincterotomes (model KD-431Q-0720) 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-431Q-0720) that could deform and lose performance if they did not undergo proper thermoforming. This risk affects medical use where precise instrument function is critical.
These disposable surgical instruments are designed to be used with endoscopes and guidewires. If they did not undergo proper thermoforming, they could deform and lose performance during medical procedures.
Healthcare professionals using these instruments for endoscopic procedures are most at risk. Patients receiving the procedure may be affected if the instrument malfunctions.
Check for model number KD-431Q-0720 on the instrument. The product was sold with valid expiration dates and includes specific material references.
Look for model number KD-431Q-0720 on the instrument to confirm if it is affected.
The instruments could deform and lose performance if they did not undergo proper thermoforming.
Check for model number KD-431Q-0720 on the instrument. The product was sold with valid expiration dates.
The recall does not specify a remedy, so contact Olympus directly for guidance.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1270-2026 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1270-2026 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.
