Olympus recalls single-use sphincterotome instruments that may deform and lose performance if not properly thermoformed. Affected models include KD-V411M-3025. Contact Olympus for details.
Devices which did not undergo thermoforming could deform and lose performance.
Olympus is recalling single-use sphincterotome instruments that could deform and lose performance if they didn't undergo proper thermoforming. This affects medical devices used during endoscopic procedures.
The instruments require thermoforming to maintain shape and function. If not properly thermoformed, they may deform and lose performance during medical procedures.
Medical professionals using these instruments for endoscopic procedures. Patients undergoing papillotomy may be at risk if the device deforms during use.
Check for model number KD-V411M-3025 on the instrument. These devices were sold with valid expiration dates and used with Olympus endoscopes for papillotomy procedures.
Look for model number KD-V411M-3025 on the instrument.
The instruments may deform and lose performance if they did not undergo proper thermoforming.
Check for model number KD-V411M-3025 on the instrument.
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-1296-2026 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1296-2026 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.
