BF-P180 EVIS EXERA II Bronchovideoscope Reprocessing Instructions Validation Recall
Olympus Corporation issued updated reprocessing instructions for 1,177 BF-P180 EVIS EXERA II Bronchovideoscopes to ensure compliance with FDA validation standards for medical device sterilization.
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 issuing updated and validated reprocessing instructions to meet FDA 2015 guidance standards, classified as a preventive instruction correction.
Plain-English summary
Olympus Corporation of the Americas is recalling the BF-P180 EVIS EXERA II Bronchovideoscope to issue validated reprocessing instructions. The recall affects 1,177 units that have been distributed domestically nationwide and globally.
The firm is issuing new reprocessing instructions in accordance with FDA 2015 guidance on validating reprocessing methods and labeling for medical devices used in healthcare settings.
Healthcare facilities using this device should consult and implement the updated reprocessing instructions provided by Olympus Corporation.
The recalled product
- Product
- BF-P180 EVIS EXERA II Bronchovideoscope, Model No. BF-P180
- Manufacturer
- Olympus Corporation of the Americas
- Hazard
- labeling-correction
- reprocessing-error
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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