Olympus recalls BF-1T60 OES Bronchofiberscope models 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-1T60 OES Bronchofiberscope models due to updated FDA reprocessing instructions. This recall ensures medical devices are safely cleaned and reused without risk of contamination.
The device requires updated reprocessing steps to prevent contamination risks. Following outdated procedures could lead to infections or device failure during medical procedures.
Healthcare facilities using the BF-1T60 OES Bronchofiberscope model are affected. Staff handling the device during procedures may be at risk if reprocessing is not done correctly.
Check for the model number BF-1T60 on the device. All serial numbers are included in this recall.
Follow the new FDA-recommended reprocessing steps for the device to ensure safety.
Olympus is issuing updated reprocessing instructions per FDA guidelines to ensure safe reuse of the device.
No, but you must follow the new reprocessing instructions to prevent contamination risks.
The official recall notice does not specify a deadline for updating reprocessing steps.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-2567-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-2567-2021 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.