Olympus recalls Single Use 3-Lumen Sphincterotome V (model KD-V411M-073: devices that didn't undergo thermoforming may deform and lose performance. Affected units sold with valid expiration dates.
Devices which did not undergo thermoforming could deform and lose performance.
Olympus is recalling Single Use 3-Lumen S: devices that didn't undergo thermoforming could deform and lose performance. This affects medical instruments used with endoscopes for papillotomy.
The devices require thermoforming to maintain proper shape and function. If not properly thermoformed, they may deform and lose performance, potentially affecting the procedure's effectiveness.
Medical professionals who use Olympus Single Use 3-Lumen Sphincterotome V instruments for endoscopic procedures. Patients undergoing papillotomy may be at risk if the device deforms during use.
Check for model number KD-V411M-0730 on the instrument. The product was sold with valid expiration dates and used with Olympus endoscopes for papillotomy procedures.
Inspect the sphincterotome for signs of deformation or improper shape after use.
The devices may deform and lose performance if they did not undergo proper thermoforming during manufacturing.
The model number is KD-V411M-0730.
The recall record does not specify a return or remedy action.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1274-2026 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1274-2026 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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