Olympus recalls BF-N20 OES Bronchofiberscope with all serial numbers due to updated FDA reprocessing instructions for medical device safety.
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-N20 OES Bronchofiberscopes because they need updated reprocessing instructions to meet FDA safety standards. This recall ensures medical devices are handled safely during cleaning and reuse.
The device requires updated reprocessing steps to comply with FDA guidelines. Without these steps, there could be risks during cleaning and reuse, but the hazard is managed through proper procedures.
Healthcare facilities using the BF-N20 OES Bronchofiberscope are affected. Medical staff and patients using this device are at low risk if proper reprocessing is followed.
Check for the BF-N20 OES Bronchofiberscope model with all serial numbers. This device is sold by Olympus Corporation of the Americas.
Follow the updated FDA-recommended reprocessing steps for safe device handling.
Olympus is issuing updated reprocessing instructions to meet FDA safety guidelines for medical device reuse.
No, but you must follow the updated reprocessing instructions to ensure safe use.
The recall does not specify a deadline for following updated 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-2564-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-2564-2021 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.
