Olympus Bronchofiberscope BF-P60 Recalled Due to Instrument Channel Port Loosening
Olympus is recalling 5,545 Bronchofiberscope BF-P60 units because attaching non-Olympus accessories may cause the instrument channel port to loosen.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a structural defect that could lead to equipment failure during use, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Olympus Corporation of the Americas is recalling 5,545 units of the Bronchofiberscope BF-P60. The recall is due to a potential defect where the attachment of non-Olympus accessories to the bronchoscope's instrument channel port may result in more applied force than expected. This increased force can lead to the loosening of the instrument channel port.
The affected products were distributed nationwide in the United States and in Canada. The recall covers all lot codes for this specific model.
Healthcare providers and consumers should stop using the Bronchofiberscope BF-P60 immediately. They should contact Olympus Corporation of the Americas for instructions on how to return the device or obtain a replacement.
The recalled product
- Product
- Bronchofiberscope BF-P60
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Endoscopy
- Affected units
- 5,545
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 lot codes
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 30 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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