Olympus recalls BF-3C40 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-3C40 OES Bronchofiberscope models due to updated FDA reprocessing guidelines. This recall ensures medical devices are safely cleaned and reused without risk of contamination.
The recall involves updated FDA reprocessing instructions to prevent contamination risks during device reuse. The hazard is related to ensuring safe cleaning procedures for medical devices in healthcare settings.
Healthcare providers using the BF-3C40 OES Bronchofiberscope are affected. Patients and staff at facilities using this model are at minimal risk if proper reprocessing is followed.
Check for the model number BF-3C40 on the device. All serial numbers are included in this recall.
Follow the new FDA-recommended reprocessing steps for safe reuse of the device.
Olympus is updating reprocessing instructions to comply with FDA guidelines for safe reuse of medical devices.
No, the device can continue to be used after following the updated reprocessing instructions.
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-2565-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-2565-2021 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.
