Olympus recalls disposable triple lumen sphincterotomes (model KD-401Q-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 (model KD-401Q-0730) that could deform and lose performance if they didn't undergo proper thermoforming. This means the instruments might not work correctly during medical procedures.
The instruments may deform if they didn't go through thermoforming, which could cause them to lose performance during medical procedures. This might lead to ineffective treatment or complications.
Medical professionals using these instruments during endoscopic procedures are most at risk. Patients receiving these procedures with affected instruments could experience improper treatment.
Check for the model number KD-401Q-0730 on the instrument. These were sold with valid expiration dates and used with Olympus endoscopes for papillotomy procedures.
Look for the model number KD-401Q-0730 on the instrument.
The instruments may deform and lose performance if they did not undergo proper thermoforming.
The recall does not specify a remedy, so check with Olympus for guidance.
The hazard could lead to improper treatment if the instrument deforms, but the recall indicates low risk.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1289-2026 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1289-2026 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.
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