Olymp: Green Silicone Seal for Accessories (Model CS-G7) recalled due to sterilization instructions in Japanese packaging differing from English IFU. No remedy stated in official notice.
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 reusable silicone seals for endoscopes (model CS-G7) because the sterilization instructions in the Japanese packaging don't match the English instructions. This could lead to improper sterilization if users follow the Japanese version instead of the English instructions.
The Japanese language product packaging has different sterilization instructions than the English Instructions For Use (IFU). If users follow the Japanese instructions instead of the English ones, they might not sterilize the seals properly, increasing infection risk.
Endoscopists and medical staff who use Olympus endoscopes with these seals. Those who follow Japanese sterilization instructions instead of the English ones are at risk of improper sterilization.
Look for the model number CS-G7 on the seal. These seals are sold with endoscopes in the U.S. by Olympus Corporation of the Americas. All lot numbers are affected.
Look for the model number CS-G7 on the seal to confirm it is affected.
The sterilization instructions in the Japanese language product packaging differ from the English Instructions For Use (IFU).
The official recall notice does not state a remedy, so no action is required beyond checking if you have the model CS-G7.
The recall is about improper sterilization due to instruction differences, not direct injury risks. No specific injury mechanism is described.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-2140-2025 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-2140-2025 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.
