Olympus Bronchofiberscope BF-P40 Recalled for Instrument Channel Port Loosening
Olympus is recalling 5,607 Bronchofiberscope BF-P40 units because attaching non-Olympus accessories may loosen the instrument channel port.
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 device failure during use, representing a risk of harm where specific injuries have not yet been reported.
Plain-English summary
Olympus Corporation of the Americas is recalling 5,607 units of the Bronchofiberscope BF-P40. The recall covers all lot codes and includes products distributed in the United States and Canada.
The recall is due to a potential defect where the attachment of non-Olympus accessories to the bronchoscope's instrument channel port may have resulted in more applied force than expected. This excessive force could lead to the loosening of the instrument channel port.
Healthcare providers and consumers should stop using the affected devices and contact Olympus Corporation of the Americas for further instructions on the recall.
The recalled product
- Product
- Bronchofiberscope BF-P40
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Endoscopy
- Affected units
- 5,607
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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