Olympus BF-N20 Bronchofiberscope Reprocessing Instructions Updated for Compliance
Olympus is updating reprocessing instructions for the BF-N20 Bronchofiberscope to comply with FDA 2015 guidance on medical device reprocessing validation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 a Class II labeling and instruction update with no reported illnesses, injuries, or hospitalizations. The recall represents a precautionary update to comply with FDA 2015 guidance on device reprocessing validation.
Plain-English summary
Olympus Corporation of the Americas is issuing updated reprocessing instructions for the BF-N20 Bronchofiberscope, affecting 377 units distributed domestically nationwide and globally.
The new reprocessing instructions are validated in accordance with the FDA 2015 guidance on reprocessing medical devices in healthcare settings. Healthcare facilities using these devices should implement the updated reprocessing procedures provided by Olympus.
The recalled product
- Product
- BF-N20 OES Bronchofiberscope, Model No. BF-N20
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 377
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.
Part of a larger recall action
This product is one of 10 recalled by Olympus Corporation of the Americas under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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