Olympus recalls BF-P60 OES Bronchofiberscopes 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 all BF-P60 OES Bronchofiberscopes due to updated FDA reprocessing guidelines. This ensures safe use in medical settings without immediate safety risks to users.
The device requires specific reprocessing steps to prevent contamination and infection risks. Failure to follow updated FDA guidelines could lead to improper cleaning and potential health hazards in medical environments.
Healthcare professionals using the BF-P60 OES Bronchofiberscope are affected. Patients and staff at facilities using this model are most at risk if reprocessing is not followed correctly.
Check for the model number BF-P60 on the device. All serial numbers are included in this recall. The product was sold by Olympus Corporation of the Americas.
Follow the updated FDA-recommended reprocessing steps for the BF-P60 OES Bronchofiberscope to ensure safety.
No, the recall does not require stopping use. Updated reprocessing instructions are provided to ensure safe use.
Continue using the device but follow the new FDA-recommended reprocessing steps to maintain safety.
The recall does not specify a deadline for following updated 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-2568-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-2568-2021 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.
