The Recall Desk
SevereFDA (Devices)·Z-2017-2023·Announced 2023-07-26

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
Category
Medical Device — Bronchoscope / Endoscopy
Hazard
  • combustion
  • burn-injury

Distribution

Distributed nationwide across the United States.

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