Olympus recalls BF-MP160F bronchofiberscopes due to potential chemical reprocessing risks. All units with serial numbers listed are affected. Contact Olympus for details.
Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing steps after high-level disinfection, and a recommendation on using sterilization
Olympus is recalling all BF-MP160F bronchofiberscopes because updated reprocessing instructions for chemicals and sterilization may pose risks. This recall affects medical devices used in procedures like bronchoscopy.
The recall involves updated instructions for chemical reprocessing and sterilization to prevent potential risks during device cleaning. Incorrect use of chemicals or sterilization steps could lead to device malfunction or injury.
Healthcare professionals using bronchofiberscopes for medical procedures are most at risk. Patients undergoing bronchoscopy may also be affected if the device is not properly maintained.
Check for the model name 'BF-MP16: EVIS EXERA Bronchofiberscope' and serial numbers listed in the recall notice. All units with the UDI 04953170289064 are affected.
Look for the serial number on the device or its packaging to confirm if it is affected.
No, this recall specifically affects BF-MP160F models with the UDI 04953170289064.
Contact Olympus directly for instructions on how to handle the device, as the recall remedy is not specified in the record.
The recall indicates potential risks from improper chemical reprocessing, but the exact hazard is not detailed in the record.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1048-2022 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1048-2022 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.
