Olympus recalls Ellik Evacuator model 194 due to differences in sterilization instructions between Japanese packaging and English product manuals. All units are affected.
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 its Ellik Evacuator model 194 because sterilization instructions in Japanese packaging differ from those in English product manuals. This discrepancy could lead to improper sterilization if users follow the incorrect instructions.
The sterilization instructions in the Japanese product packaging differ from the English Instructions For Use. If users follow the Japanese instructions, they might not sterilize the device correctly, increasing infection risk.
Medical professionals using the Ellik Evacuator for surgical procedures are likely affected. Those who follow the Japanese instructions instead of the English ones may face improper sterilization.
Check for model number 194 on the Ellik Evacuator. All units are affected, including those sold with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
Check the English Instructions For Use for correct sterilization procedures.
Yes, if you have the Ellik Evacuator model 194, it is affected due to differences in sterilization instructions between Japanese packaging and English product manuals.
The recall does not require returning the device; users should follow the correct sterilization instructions from the English product manuals.
Following the Japanese instructions may lead to improper sterilization. Always use the English Instructions For Use for correct procedures.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-2143-2025 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-2143-2025 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.
