Olymp: Ellik Evacuator tubing model 190-4 recalled due to Japanese language sterilization instructions differing from English product instructions. No remedy stated in official notice.
Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
Olympus is recalling tubing for their Ellik Evacuator model 190-4 because sterilization instructions in Japanese product packages don't match the English instructions. This could lead to improper sterilization if users follow the Japanese instructions instead of the English ones.
The Japanese language sterilization instructions on the product package differ from the English instructions published by the manufacturer. If users follow the Japanese instructions instead of the English ones, they might sterilize the tubing incorrectly, potentially leading to contamination.
Users of the Ellik Evacuator tubing model 190-4 who follow Japanese sterilization instructions instead of English ones. Medical professionals using this tubing for surgical procedures are most at risk.
Check for the model number 190-4 on the tubing. The product was sold with UDI-DI: 00821925003491. All lot numbers are affected.
Verify that you are using the English language sterilization instructions instead of Japanese ones.
The official recall notice does not state any remedy.
The model number is 190-4.
Look for the model number 190-4 and UDI-DI: 00821925003491 on the tubing.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-2142-2025 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-2142-2025 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.