Olympus recalls BF-1T180 EVIS EXERA II Bronchovideoscopes with updated reprocessing instructions per FDA 2015 guidance. All units with serial numbers are affected.
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 all BF-1T180 EVIS EXERA II bronchovideoscopes due to updated reprocessing instructions following FDA guidance. This is a safety update to ensure proper device handling in healthcare settings.
The device requires updated reprocessing steps to meet FDA 2015 guidelines. Improper reprocessing could lead to contamination or infection risks if not followed correctly.
Healthcare professionals using the BF-1T180 EVIS EXERA II bronchovideoscope are affected. Patients and staff at facilities with this model are most at risk if reprocessing is not done correctly.
Check for the model number BF-1T180 on the bronchovideoscope. All units with this model and any serial number are included in the recall.
Follow the updated FDA-recommended reprocessing steps for the device to ensure safety.
Olympus is issuing updated reprocessing instructions to comply with FDA 2015 guidance on medical device reprocessing.
No, but you must follow the updated reprocessing instructions to ensure safe use.
Check the model number and serial number; follow the updated reprocessing steps as provided by Olympus.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-2572-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-2572-2021 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.