Olympus recalls BF-XP160F EVIS EXERA Bronchovideoscope due to updated FDA reprocessing instructions. All units with serial numbers are affected. No immediate action needed but follow new safety protocols.
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-XP160F EVIS EXERA Bronchovideoscope to update reprocessing instructions per FDA guidelines. This is a safety update to ensure proper device handling in healthcare settings, but no immediate action is required for users.
The device requires updated reprocessing steps to meet FDA safety standards. Incorrect handling could lead to contamination or improper sterilization, though this is a procedural update rather than a physical hazard.
Healthcare professionals using the BF-XP160F EVIS EXERA Bronchovideoscope are affected. Patients and staff at facilities with this model are most at risk if reprocessing isn't done correctly.
Check if your bronchovideoscope has the model number BF-XP160F. All units with this model and any serial number are included in the recall.
Follow the updated FDA-recommended reprocessing instructions for the device to ensure safety.
No, the recall is for updated reprocessing instructions, not a stop-use order.
The recall addresses procedural safety, not a physical hazard that causes injury.
All BF-XP160F EVIS EXERA Bronchovideoscopes with any serial number are affected.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-2569-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-2569-2021 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.
