Olympus recalls glass body for 194 Ellik Evacuator (model 190A) due to inconsistent sterilization. Affected units may not be sterile after use, posing infection risks. Contact Olympus for details.
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 glass bodies for the 194 Ellik Evacuator (model 190A) because some sterilization settings might not properly sterilize the device. This could lead to infections if the device is used without proper sterility.
The sterilization process may not consistently render the device sterile due to incorrect settings in the instructions. This could allow harmful bacteria to remain on the device, increasing infection risk during medical procedures.
Healthcare professionals using the 194 Ellik Evacuator in medical settings are most at risk. The recall applies to all units with model number 190A.
Check for the model number 190A on the glass body. The product was sold with the UDI-DI: 00821925003538 and all lot numbers.
Look for model number 190A on the glass body to confirm if it is affected.
The sterilization parameters in the instructions may not consistently render the device sterile, increasing infection risk.
Check for model number 190A on the glass body. The product was sold with UDI-DI: 00821925003538 and all lot numbers.
The recall does not specify a remedy, so contact Olympus directly for guidance.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-2721-2026 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-2721-2026 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.
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