Olympus recalls BF-P180 EVIS EXERA II Bronchovideoscope with updated FDA-recommended reprocessing instructions to ensure safety in healthcare settings.
The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
Olympus is recalling its BF-P180 EVIS EXERA II Bronchovideoscope due to updated FDA reprocessing instructions. This change ensures safe use in healthcare settings without requiring immediate action from users.
The device requires updated reprocessing steps per FDA guidelines to maintain safety during medical procedures. This update addresses best practices for cleaning and sterilizing the bronchovideoscope without causing harm.
Healthcare professionals using the BF-P180 EVIS EXERA II Bronchovideoscope are affected. The risk is low as this involves updated reprocessing guidelines rather than a physical defect.
Check for the model number BF-P180 on the device or its packaging. All serial numbers are included in this recall.
Check the device for updated FDA-recommended reprocessing steps to ensure safe use in healthcare settings.
No, the recall involves updated reprocessing instructions, not a stop-use order.
Continue using the device with the latest FDA-recommended reprocessing steps.
The recall addresses reprocessing safety, not a direct injury risk from the device itself.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-2571-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-2571-2021 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.
