Olympus recalls single-use sphincterotome devices that may deform if not properly thermoformed, risking loss of function during medical procedures.
Devices which did not undergo thermoforming could deform and lose performance.
Olympus is recalling single-use sphincterotome surgical instruments that could deform and lose performance if not properly thermoformed. This affects medical use where precise function is critical.
The devices require thermoforming to maintain proper shape and function. Without this process, they may deform during use, potentially causing loss of performance in critical medical procedures.
Medical professionals using these instruments for endoscopic procedures. Patients undergoing papillotomy procedures with this device may be at risk if the instrument deforms.
Check for model number KD-VC411Q-0720 on the instrument. These were sold with valid expiration dates and used with Olympus endoscopes for papillotomy procedures.
Look for model number KD-VC411Q-0720 on the instrument.
The devices could deform and lose performance if not properly thermoformed, which may affect their function during medical procedures.
The recall does not specify a remedy, so contact Olympus directly for guidance.
The device is safe if properly thermoformed, but may deform if not, potentially affecting performance.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1278-2026 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1278-2026 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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