Olympus EVIS EXERA Bronchoscope Recalled for Combustion Risk During Laser Procedures
The FDA recalls 284 Olympus EVIS EXERA bronchoscopes due to complaints of combustion during therapeutic laser procedures. Users should stop using affected models immediately.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recalls require a minimum classification of Severe. The hazard of endobronchial combustion during laser procedures presents a serious risk of injury. While complaints of this hazard have been reported, the source does not explicitly document fatalities or serious injuries, which would elevate this to Critical.
Plain-English summary
Olympus Corporation of the Americas has recalled the EVIS EXERA BRONCHOVIDEOSCOPE BF TYPE, Model Number BF-XT160. The FDA has classified this as a Class I recall.
The recalled bronchoscope has been associated with complaints of endobronchial combustion during therapeutic laser procedures. Endobronchial combustion refers to fire or burning within the airway during the procedure.
The recall affects 284 units of this model that were distributed nationwide in the United States. All units with serial numbers beginning with BF-XT160* are affected.
Healthcare facilities and providers should discontinue use of this bronchoscope model and contact Olympus Corporation of the Americas for instructions on safe disposal or replacement.
The recalled product
- Product
- Olympus EVIS EXERA BRONCHOVIDEOSCOPE BF TYPE, Model Number BF-XT160
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device
- Hazard
- Affected units
- 284
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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