Olympus recalls Ellik Evacuator Adapter Model 190-NRS due to discrepancies between Japanese language sterilization instructions and English product instructions. Affected users should contact Olympus for details.
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 Evacuator Adapter Model 190-NRS because sterilization instructions in Japanese product packaging differ from the English instructions. This could lead to improper sterilization if users follow the wrong instructions.
The hazard arises from differences between Japanese language instructions and English product instructions for sterilization. If users follow the incorrect instructions, it could lead to improper sterilization of the device.
Users of the Ellik Evacuator Adapter Model 190-NRS, particularly those in medical settings that use the device for surgical procedures. Medical professionals handling the device are most at risk.
Check for the model number 190-NRS on the adapter. The product is sold with UDI-DI: 00821925003521 and all lot numbers.
Reach out to Olympus Corporation of the Americas for specific instructions on how to handle the recalled product.
The recall is due to discrepancies in sterilization instructions, not a safety hazard if used correctly.
Contact Olympus Corporation of the Americas for specific instructions on handling the recalled product.
The recall addresses potential improper sterilization, not direct injury risks.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-2145-2025 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-2145-2025 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.