The Recall Desk
SevereFDA (Devices)·Z-2011-2023·Announced 2023-07-26

Olympus OES Bronchofiberscope Models Recalled for Combustion Risk During Laser Procedures

Olympus is recalling OES Bronchofiberscope models due to reports of combustion during laser procedures. This poses a serious burn injury risk to patients.

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 mandates a minimum severity score of 4 per the rubric. The hazard—endobronchial combustion during laser procedures—directly poses serious thermal burn injury risk to patients.

Plain-English summary

Olympus Corporation of the Americas is recalling specific models of the OES Bronchofiberscope: the BF-XT40, BF-P60, BF-MP60, and BF-1T60. Approximately 1535 units of these devices have been distributed nationwide in the United States.

The FDA has classified this as a Class I recall due to reports of endobronchial combustion occurring during therapeutic laser procedures when using these bronchofiberscopes. Endobronchial combustion poses a serious risk of thermal burn injury to patients undergoing these procedures.

The recalled product

Product
Olympus OES BRONCHOFIBERSCOPE BF Type, Model Numbers BF-XT40, BF-P60, BF-MP60, BF-1T60
Manufacturer
Olympus Corporation of the Americas
Category
Medical Device — Bronchoscopy
Hazard
  • combustion
  • burn-injury

Distribution

Distributed nationwide across the United States.

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