Olymp: Blue Silicone Reusable Seal 6-12 FR (Model CS-B612) recalled due to Japanese sterilization instructions differing from English product instructions. This may lead to improper sterilization.
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 Blue Silicone Reusable Silicone Seal 6-12 FR (Model CS-B612) because sterilization instructions in Japanese product packages differ from the English instructions. This discrepancy could lead to improper sterilization of the seal, potentially causing infections during medical procedures.
The seals are designed to fit over biopsy ports on endoscopes to seal the working channel. If sterilization instructions differ between Japanese and English versions, the seals might not be properly sterilized, increasing infection risk during procedures.
Medical professionals who use endoscopes with these seals during procedures. Patients undergoing endoscopic procedures may be at risk if the seals are not properly sterilized.
Look for the Blue Silicone Reusable Silicone Seal 6-12 FR with model number CS-B612. The product was sold with UDI-DI numbers 00821925038318 and 00821925001176. All lot numbers are affected.
Identify the model number CS-B612 and UDI-DI numbers 00821925038318 or 00821925001176 to confirm if your seal is affected.
The recall is due to discrepancies between Japanese sterilization instructions in product packages and English instructions published in the manufacturer's product Instructions For Use.
Check for model number CS-B612 and UDI-DI numbers 00821925038318 or 00821925001176. All lot numbers are affected.
The recall does not specify a remedy, so contact Olympus Corporation of the Americas for further instructions.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-2139-2025 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-2139-2025 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.
