Olympus recalls BF-XT160 EVIS EXERA Bronchovideoscopes due to updated FDA-recommended reprocessing instructions for medical devices.
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-XT160 EVIS EXERA Bronchovideoscopes to update reprocessing instructions following FDA guidance. This ensures safe medical device handling without changing the product itself.
The recall follows FDA guidance requiring updated reprocessing instructions for medical devices. This ensures safe reuse of the bronchovideoscope without introducing risks from improper cleaning or sterilization.
Healthcare professionals using the BF-XT160 Bronchovideoscope in medical settings. Patients are not at risk as the recall involves updated procedures, not a product defect.
Check for the model number BF-XT160 on the device. All units with this model are affected, regardless of serial number.
Olympus has issued updated reprocessing instructions per FDA 2015 guidance for safe medical device use.
Olymp: Olympus is updating reprocessing instructions to comply with FDA 2015 guidance for safe medical device handling.
No, the recall does not require stopping use. Updated reprocessing instructions ensure safe continued use.
No, this is a procedural update for reprocessing to meet FDA standards, not a product defect.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-2570-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-2570-2021 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.
