The Recall Desk
SevereFDA (Devices)·Z-2013-2023·Announced 2023-07-26

Olympus Bronchoscope Recall: Risk of Combustion During Laser Procedures

Olympus is recalling 9 bronchoscopes (Models BF-P150 and BF-1T150) due to complaints of endobronchial combustion during therapeutic laser procedures. The defect could cause fire and serious burn injuries.

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: This is an FDA Class I medical device recall, which establishes a minimum severity score of 4. The hazard—endobronchial combustion during laser procedures—presents substantial risk of serious burn injury to patients, meeting the criteria for Severe classification.

Plain-English summary

Olympus Corporation of the Americas is recalling 9 Olympus BRONCHOVIDEOSCOPE units (Model Numbers BF-P150 and BF-1T150) distributed nationwide in the United States.

The recall is due to complaints of endobronchial combustion occurring during therapeutic laser procedures performed with the bronchoscope. Endobronchial combustion refers to an unintended fire occurring within the patient's bronchial passages during the laser treatment.

Patients undergoing bronchoscopy with laser therapy using these devices are at risk of serious burn injury. Hospitals and medical facilities that have these models should immediately cease use and contact Olympus Corporation of the Americas for instructions on return or replacement.

The recalled product

Product
Olympus BRONCHOVIDEOSCOPE BF Type, Model Numbers BF-P150, BF-1T150
Manufacturer
Olympus Corporation of the Americas
Category
Medical Device — Bronchoscopy / Endoscopy
Hazard
  • fire
  • burn-injury

Distribution

Distributed nationwide across the United States.

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