The Recall Desk
SevereFDA (Devices)·Z-2014-2023·Announced 2023-07-26

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.

What this means for you

Illness, injury, or structural failure has been reported. 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
  • combustion
  • burn-injury

Distribution

Distributed nationwide across the United States.

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