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 devices that could deform and lose performance if not properly thermoformed. This affects medical procedures where the device is used with an endoscope for papillotomy.
The devices could deform if they did not undergo proper thermoforming, which might cause them to lose performance during medical procedures. This could impact the effectiveness of the device when used with an endoscope for papillotomy.
Medical professionals using the Olympus Single Use 3-Lumen Sphincterotome V (Model KD-VC412Q-0215) for endoscopic procedures are most at risk. Patients receiving these procedures may also be affected if the device malfunctions.
Check for the model number KD-VC412Q-0215 on the device. The product was sold with a valid expiration date and includes specific material references.
Verify if the device underwent thermoforming by checking for proper material references and expiration date.
The devices could deform and lose performance if they did not undergo proper thermoforming during manufacturing.
The recall does not specify a remedy, so check with Olympus directly for guidance.
The recall indicates potential deformation risk if not properly thermoformed, but no specific safety concerns are stated for correctly manufactured devices.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1282-2026 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1282-2026 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.
