Olympus BF-XP60 Bronchofiberscope Reprocessing Instructions Updated for Validation Compliance
Olympus Corporation issued updated reprocessing instructions for the BF-XP60 bronchofiberscope to align with FDA 2015 guidance on medical device reprocessing validation and labeling.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The recall involves updated reprocessing instructions for a medical scope; while proper sterilization is critical to prevent contamination, the source provides no evidence of adverse events.
Plain-English summary
Olympus Corporation of the Americas has issued updated, validated reprocessing instructions for the BF-XP60 OES Bronchofiberscope, Model No. BF-XP60. The recall affects approximately 180 units distributed nationwide and globally.
The firm is issuing these validated reprocessing instructions in accordance with FDA 2015 guidance titled 'Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.' This update ensures that reprocessing procedures comply with current FDA standards for medical device sterilization and disinfection.
Healthcare facilities and medical centers using this device should implement the new reprocessing instructions immediately. Contact Olympus Corporation of the Americas for the updated instructions if you have not already received them.
The recalled product
- Product
- BF-XP60 OES Bronchofiberscope, Model No. BF-XP60
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Endoscope
- Hazard
- contamination
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All serial numbers
Distribution
Distributed nationwide across the United States.
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