Agency classClass IOur severity:Severe FDA (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.

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 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
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 →

Same manufacturer · Olympus Corporation of the Americas

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