Olympus recalls single-use sphincterotome devices that may deform and lose performance if not properly thermoformed. Affected models include KD-V411M-3020. Consumers should check product details and contact Olympus for guidance.
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 devices used during endoscopic procedures. The recall is for specific model numbers sold with valid expiration dates.
These devices require proper thermoforming to maintain their shape and function. If not thermoformed correctly, they may deform and lose performance during medical procedures, potentially affecting treatment outcomes.
Medical professionals using Olympus Single Use 3-Lumen Sphincterotome V devices with model number KD-V411M-3020 are most at risk. Patients undergoing endoscopic procedures with these devices may also be affected.
Check for model number KD-V411M-3020 on the device. The product was sold with valid expiration dates and used with Olympus endoscopes for papillotomy procedures.
Look for model number KD-V411M-3020 on the device label.
The devices may deform and lose performance if not properly thermoformed, which could affect medical procedures.
Check for model number KD-V411M-3020 on the device label. The product was sold with valid expiration dates and used with Olympus endoscopes for papillotomy procedures.
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-1295-2026 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1295-2026 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.
