Olympus recalls BF-XP60 OES Bronchofiberscope with updated reprocessing instructions per FDA 2015 guidance. No immediate action needed for 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 its BF-XP60 OES Bronchofiberscope due to updated reprocessing instructions following FDA guidance. This does not pose an immediate safety risk to users.
The device requires updated reprocessing instructions to comply with FDA 2015 guidance. This ensures proper cleaning and sterilization without introducing safety risks.
Healthcare professionals using the BF-XP60 OES Bronchofiberscope are affected. The risk is low as this involves updated reprocessing procedures rather than a safety hazard.
Check for the model number BF-XP60 on the device. All units with this model are affected, regardless of serial number.
Follow the updated reprocessing instructions provided by Olympus to ensure safe use.
No, the recall does not require stopping use. Updated reprocessing instructions are needed for safety.
The device itself is not dangerous; the recall involves updated reprocessing procedures to comply with FDA guidelines.
All BF-XP60 OES Bronchofiberscope models are affected, regardless of serial number.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-2566-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-2566-2021 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
