Olympus recalls EVIS EXERA Bronchovideoscope (BF-3C160) due to updated reprocessing instructions for chemicals and sterilization. All units with serial numbers are affected.
Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing steps after high-level disinfection, and a recommendation on using sterilization
Olymp: Olympus is recalling all EVIS EXERA Bronchovideoscopes (BF-3C16:160) because their reprocessing instructions for chemicals and sterilization need updating. This could lead to improper use if not followed correctly.
The device requires updated instructions for chemical reprocessing and sterilization to prevent potential issues with the reprocessing chemicals and sterilization steps. If not followed correctly, it could lead to improper cleaning or sterilization.
Healthcare professionals using the EVIS EXERA Bronchovideoscope for medical procedures are most affected. All units with the specified serial numbers are included in this recall.
Check the serial number on the device. The recall includes all units with the serial number range starting with 04953170340031.
Look for the serial number on the device to confirm if it is affected by this recall.
Yes, the recall includes all units with the serial number starting with 04953170340031.
Check the serial number on the device to see if it is affected by this recall. If it is, you should check the updated instructions for reprocessing and sterilization.
The recall is for updated instructions to ensure proper reprocessing and sterilization, which is a low-risk issue.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1047-2022 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1047-2022 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.
