Olympus Bronchovideoscope Recalled Due to Oversized Diameter
Olympus is recalling two models of bronchovideoscope (Models BF-3C40 and BF-N20) because the endoscope diameter is too large and may become lodged in the endotracheal tube connector.
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: FDA Class II medical device recall for a mechanical defect creating a risk of airway obstruction during respiratory procedures. No injuries reported in source material; the hazard is a potential device malfunction rather than an actualized harm.
Plain-English summary
Olympus Corporation of the Americas is recalling the Olympus Bronchovideoscope Models BF-3C40 and BF-N20. A total of 881 units were distributed nationwide.
The endoscope has been found to have a diameter that is too large, which can cause the device to become lodged in the endotracheal tube connector during use. This mechanical defect poses a risk of airway obstruction if the endoscope becomes stuck during respiratory procedures.
The affected serial numbers include all units with UDI-DI codes 04953170308130, 04953170339219, 04953170051142, and 04953170442667. Healthcare facilities and clinicians using these models should immediately cease use of the affected devices and contact Olympus Corporation of the Americas for instructions on return or replacement.
The recalled product
- Product
- Olympus Bronchovideoscope, Models BF-3C40 & BF-N20.
- Manufacturer
- Olympus Corporation of the Americas
- Hazard
- mechanical-defect
- airway-obstruction
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 (5)
- UDI-DI: 04953170308130
- 04953170339219
- 04953170051142
- & 04953170442667
- All Serial Numbers.
Distribution
Distributed nationwide across the United States.
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