Olympus BF-P60 Bronchofiberscope Reprocessing Instructions Updated to Meet FDA Guidance
Olympus Corporation has issued new, validated reprocessing instructions for the BF-P60 OES Bronchofiberscope to comply with FDA guidance. The recall affects 1,030 devices distributed nationwide and internationally.
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 device recall with no reported illnesses or injuries. The hazard is theoretical and related to proper reprocessing procedures. The firm is proactively issuing corrective instructions, consistent with a voluntary precautionary recall classified as Moderate per the rubric.
Plain-English summary
The BF-P60 OES Bronchofiberscope is a medical device manufactured by Olympus Corporation of the Americas. A total of 1,030 units have been distributed domestically nationwide and internationally, with all serial numbers included in this recall action.
Olympus Corporation is issuing new, validated reprocessing instructions for the BF-P60 OES Bronchofiberscope in accordance with FDA 2015 guidance on reprocessing medical devices in health care settings. The new instructions address validation methods and labeling requirements as outlined in the FDA guidance.
Healthcare facilities and healthcare providers using the BF-P60 OES Bronchofiberscope should obtain and implement the new reprocessing instructions provided by Olympus Corporation. Staff responsible for device reprocessing should be trained on the updated instructions to ensure proper handling and maintenance of the device.
The recalled product
- Product
- BF-P60 OES Bronchofiberscope, Model No. BF-P60
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 1,030
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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