Olympus recalls Ellik Evacuators (model 191-NRS) due to sterilization instructions in Japanese packaging differing from English product manuals. 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).
Olymp: The Olympus Ellik Evacuator (model 191-NRS) is recalled 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 hazard comes from discrepancies between Japanese-language product packaging and English product instructions for sterilization. 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 (model 191-NRS) who follow Japanese sterilization instructions instead of the English product manual are at risk of improper sterilization. Medical professionals using this device are most affected.
Check for the model number 191-NRS on the Ellik Evacuator. The device is sold with the model number 191-NRS and UDI-DI: 00821925003545. All lot numbers are affected.
Review the English product instructions for sterilization to ensure you follow the correct procedure.
The recall is due to discrepancies between sterilization instructions in Japanese packaging and English product manuals.
The official notice does not specify a remedy, so contact Olympus directly for guidance.
The recall addresses potential improper sterilization, not direct injury risks. The hazard level is low risk.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-2146-2025 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-2146-2025 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
