Olympus EVIS EXERA III Bronchovideoscope Combustion Hazard Recall
Olympus is recalling EVIS EXERA III Bronchovideoscopes nationwide due to complaints of endobronchial combustion during therapeutic laser procedures. This FDA Class I recall affects approximately 9,684 units.
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 device is subject to an FDA Class I classification, which requires a minimum severity score of 4. The hazard involves endobronchial combustion during therapeutic procedures, which poses serious risk of burn injury. However, no deaths, hospitalizations, or specific injury incidents are documented in the source text.
Plain-English summary
Olympus Corporation of the Americas is recalling the EVIS EXERA III BRONCHOVIDEOSCOPE BF TYPE, including models BF-H190, BF-Q190, BF-XT190, and BF-1TH190, due to complaints of endobronchial combustion during therapeutic laser procedures with the device.
The recall affects approximately 9,684 units distributed nationwide across the United States. All serial numbers of the affected models are included in the recall. The FDA has classified this as a Class I recall, indicating a serious hazard that may result in adverse health consequences or death.
The recalled product
- Product
- Olympus EVIS EXERA III BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-H190, BF-Q190, BF-XT190, BF-1TH190
- Manufacturer
- Olympus Corporation of the Americas
- Hazard
- Affected units
- 9,684
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 Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- ModerateOlympus 4K UHD LCD Monitors Recalled Due to Potential Connector Faults
FDA (Devices) · 2026-07-29
- HighOlympus High Flow Insufflation Unit UHI-4 Recalled Due to Display and Air Delivery Failure
FDA (Devices) · 2026-07-29
- HighOlympus Toomey Evacuator 30cc medical device sterilization parameters recalled
FDA (Devices) · 2026-07-22
- HighOlympus Toomey Evacuator 50cc with Adaptor sterilization recall
FDA (Devices) · 2026-07-22
Same hazard · combustion
See all →- SevereOlympus Bronchovideoscope Recall for Combustion Risk with Electrosurgery
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
- SevereFive Olympus Bronchovideoscope Models Recalled for Endobronchial Combustion Risk
FDA (Devices) · 2023-11-15
- SevereOlympus Bronchovideoscope Recalled Due to Combustion Risk
FDA (Devices) · 2023-11-15