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.
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: 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
- Affected units
- 1,535
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.
See all 7 products in this recall →Related recalls
Same manufacturer · Olympus Corporation of the Americas
See all →- ModerateOlympus DisplayPort Cable Recalled for Video Dropout Risk
FDA (Devices) · 2026-10-07
- ModerateOlympus M3 Gold Autoclavable Foroblique Telescope Recalled for Sterilization Labeling Discrepancy
FDA (Devices) · 2026-10-07
- ModerateOlympus M3 Gold Autoclavable Lateral Telescope 70 Recalled for Sterilization Labeling Discrepancies
FDA (Devices) · 2026-10-07
- ModerateOlympus Endoscopic Balloon Dilator Recalled for Incorrect Inflation Chart Label
FDA (Devices) · 2026-09-30
- SevereOlympus BiCOAG Hemostasis Probe Recall Due to Ceramic Tip Detachment Risk
FDA (Devices) · 2026-09-30
Same hazard · combustion
See all →- SevereFive Olympus Bronchovideoscope Models Recalled for Endobronchial Combustion Risk
FDA (Devices) · 2023-11-15
- SevereFDA Recalls Olympus EVIS EXERA III Bronchovideoscope for Combustion Risk
FDA (Devices) · 2023-11-15
- SevereOlympus Bronchovideoscopes Recalled for Endobronchial Combustion Risk
FDA (Devices) · 2023-11-15
- SevereOlympus Bronchovideoscope Recall for Combustion Risk with Electrosurgery
FDA (Devices) · 2023-11-15
- SevereOlympus Bronchovideoscope Recalled Due to Combustion Risk
FDA (Devices) · 2023-11-15
Similar recalls
- SevereFive Olympus Bronchovideoscope Models Recalled for Endobronchial Combustion Risk
FDA (Devices) · 2023-11-15
- CriticalBF-1T60 bronchofiberscopes recalled for updated instructions on energy therapy equipment
FDA (Devices) · 2025-10-22
- SevereOlympus Bronchovideoscopes Recalled for Endobronchial Combustion Risk
FDA (Devices) · 2023-11-15
- SevereOlympus Bronchovideoscope Recalled Due to Combustion Risk
FDA (Devices) · 2023-11-15
- SevereOlympus Bronchovideoscope Recalled for Fire Risk During Cauterization
FDA (Devices) · 2023-11-15
- CriticalBF-XT40 bronchofiberscopes recalled for updated therapy equipment use instructions
FDA (Devices) · 2025-10-22