Olympus recalls Ellik Latex Bulb and Evacuator model 194-2 due to inconsistent sterilization instructions in Japanese vs. English product guides. Affected units may not be properly sterilized, risking infection.
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 Ellik Latex Bulb and Ellik Evacuator model 194-2 because sterilization instructions differ between Japanese packaging and English product guides. This could lead to improper sterilization and infection risks if the devices are used without following the correct instructions.
The sterilization instructions in the Japanese language product package inserts do not match the English Instructions For Use (IFU). This discrepancy could lead to improper sterilization of the devices, increasing the risk of infection during medical procedures.
Medical professionals using these devices during surgeries or procedures are most at risk. Patients using these devices may face infection if not properly sterilized.
Check for model number 194-2 on the Ellik Latex Bulb or Ellik Evacuator. The device also has a unique device identifier (UDI) starting with 00821925002593. All units produced are affected.
Review the English Instructions For Use (IFU) to ensure proper sterilization procedures are followed.
The sterilization instructions in the Japanese language product package inserts differ from the English Instructions For Use (IFU), which could lead to improper sterilization and infection risks.
Model number 194-2 for Ellik Latex Bulb and Ellik Evacuator.
No immediate stop is required, but you should follow the English Instructions For Use (IFU) for proper sterilization to avoid infection risks.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-2144-2025 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-2144-2025 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.
