Olympus Bronchovideoscope Recalled for Endobronchial Combustion Risk
Olympus is recalling 17,609 bronchovideoscope units nationwide due to complaints of endobronchial combustion during therapeutic laser procedures, which poses a fire and burn risk to patients.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: FDA Class I recall classification qualifies as Critical per the regulatory severity rubric. Endobronchial combustion during therapeutic procedures poses a serious risk of airway burn injury.
Plain-English summary
Olympus Corporation of the Americas is recalling 17,609 units of the EVIS EXERA II BRONCHOVIDEOSCOPE (Model Numbers BF-P180, BF-Q180, BF-Q180-AC, BF-1T180, and BF-1TQ180) distributed nationwide in the United States. This is a Class I recall issued by the U.S. Food and Drug Administration (FDA).
There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchovideoscope. Endobronchial combustion—burning within the airway—poses a serious risk of injury to patients undergoing these procedures.
Healthcare facilities and medical professionals using these devices should discontinue use and contact Olympus Corporation of the Americas for instructions regarding return or replacement of affected equipment. Patients who have undergone or are scheduled for procedures with these devices should consult their healthcare provider about any concerns.
The recalled product
- Product
- Olympus EVIS EXERA II BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-P180, BF-Q180, BF-Q180-AC, BF-1T180, BF-1TQ180
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 17,609
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 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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