Olympus Bronchovideoscope BF-3C160 Recalled for Instrument Channel Port Loosening
Olympus is recalling 2,318 Bronchovideoscope BF-3C160 units because attaching non-Olympus accessories may have caused the instrument channel port to loosen.
What this means for you
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 (loosening port) that poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Olympus Corporation of the Americas is recalling 2,318 units of the Bronchovideoscope BF-3C160. The recall covers all lot codes and includes products distributed in the United States and Canada.
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. This excessive force may have led to the loosening of the instrument channel port.
The source text does not specify specific actions for consumers or healthcare providers, nor does it report any injuries or illnesses associated with this defect.
The recalled product
- Product
- Bronchovideoscope BF-3C160
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Endoscopy
- Hazard
- Affected units
- 2,318
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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