Olympus recalls Ellik Evacuator model 194 due to potential failure to sterilize properly. Affected units may not be sterile after use, risking infection. Stop using immediately.
Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.
Olympus is recalling its Ellik Evacuator model 194 because some sterilization settings might not make it sterile enough. This could lead to infections if used improperly. Affected users should stop using the device immediately.
The device may not sterilize properly when using certain settings in the instructions. This means medical tools could become contaminated and cause infections during procedures.
Users of the Olympus Ellik Evacuator model 194 are affected. Healthcare professionals and medical facilities that use this device for sterilization are most at risk.
Check for the model number 194 on the glass body. The product includes a glass body, male connecting tubing, and latex bulb. All lot numbers are affected.
Immediately stop using the Olympus Ellik Evacuator model 194 as it may not sterilize properly.
The recall is because some sterilization parameters in the instructions may not consistently render the device adequately sterile, risking infections.
Model number 194 is affected. All lot numbers are included in the recall.
Look for the model number 194 on the glass body. The product includes a glass body, male connecting tubing, and latex bulb.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-2720-2026 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-2720-2026 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.