Olymp: 194 Ellik Evacuator glass bodies (model 190A) recalled due to sterilization instructions in Japanese packaging differing from English product manuals.
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 194 glass bodies for the Ellik Evacuator (model 190A) because sterilization instructions in Japanese packaging don't match the English product manual. This could lead to improper sterilization if users follow the Japanese instructions instead of the English ones.
The Japanese language product package inserts have different sterilization instructions than the English product Instructions For Use (IFU). If users follow the Japanese instructions instead of the English ones, they might sterilize the device incorrectly, potentially leading to contamination.
Users of the Ellik Evacuator surgical device who purchased the glass body (model 190A) from Olympus. Surgeons and medical staff using the device are most at risk if they follow the Japanese instructions instead of the English ones.
Check for the model number 190A on the glass body. The product was sold with the Ellik Evacuator and compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths. All lot numbers are affected.
Verify the model number on the glass body is 190A.
Ensure you are using the English product Instructions For Use (IFU) for sterilization, not the Japanese package inserts.
The Japanese language product package inserts have different sterilization instructions than the English product Instructions For Use (IFU).
Model number 190A for the Ellik Evacuator glass body.
The official recall does not provide a fix; users must follow the English product Instructions For Use (IFU) for sterilization.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-2141-2025 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-2141-2025 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.
