Olympus Bronchofiberscope BF-40 Recalled for Instrument Channel Port Loosening
Olympus is recalling 1,347 Bronchofiberscope BF-40 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 is classified as FDA Class II, and the hazard involves a structural defect in a medical device that could lead to harm, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Olympus Corporation of the Americas is recalling 1,347 units of the Bronchofiberscope BF-40. The recall was initiated because the attachment of non-Olympus accessories to the bronchoscope's instrument channel port may have resulted in more applied force than expected, leading to the loosening of the instrument channel port.
The affected products were distributed in the United States nationwide and in Canada. The recall covers all lot codes for this specific device model.
Healthcare providers and consumers should stop using the affected Bronchofiberscope BF-40 units and contact Olympus Corporation of the Americas for further instructions on how to proceed with the recall.
The recalled product
- Product
- Bronchofiberscope BF-40
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Endoscopy
- Hazard
- Affected units
- 1,347
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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