Olympus recalls EVIS EXERA II Bronchovideoscope (Model BF-Q180-AC) for 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 EVIS EXERA II Bronchovideoscope (Model BF-Q180-AC) to provide updated reprocessing instructions aligned with FDA guidelines. This recall ensures medical devices are handled safely during cleaning and reuse in healthcare facilities.
The device requires updated reprocessing steps to meet FDA safety standards for reuse in medical settings. Without proper reprocessing, there could be risks of contamination or infection during device reuse.
Healthcare facilities using the EVIS EXERA II Bronchovideoscope with model number BF-Q180-AC are affected. Staff handling the device during reprocessing are at the highest risk.
Check for the model number BF-Q180-AC on the device. All units with this model number are included in the recall, regardless of serial number.
Follow the new FDA-recommended reprocessing steps for the device to ensure safe reuse in healthcare settings.
Olympus is issuing updated reprocessing instructions to comply with FDA guidelines for safe reuse of the device in healthcare settings.
No, the device can continue to be used after following the updated reprocessing instructions.
The official recall notice does not specify a deadline for implementing the new reprocessing instructions.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-2573-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-2573-2021 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.
