The Recall Desk
CriticalFDA (Devices)·Z-2016-2023·Announced 2023-07-26

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.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. 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
Hazard
  • endobronchial-combustion
  • fire
  • burn-injury

Distribution

Distributed nationwide across the United States.