FDA Recalls Olympus EVIS EXERA III Bronchovideoscope for Combustion Risk
Olympus Corporation is recalling 3,948 EVIS EXERA III bronchovideoscope units nationwide due to risk of combustion during electrosurgical procedures when high-frequency cauterization is used with oxygen supply.
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: FDA Class I medical device recall. Although no injuries or deaths have been reported, the risk of endobronchial combustion during electrosurgical procedures represents a serious potential hazard, meeting the threshold for Severe classification.
Plain-English summary
Olympus Corporation of the Americas is recalling EVIS EXERA III bronchovideoscope units (Model Number BF-P190) that were distributed nationwide in the United States. Approximately 3,948 devices are affected.
The recall is due to a risk of endobronchial combustion. This hazard can occur when high-frequency cauterization is performed while oxygen is supplied and the electrode section of the electrosurgical accessory is positioned too close to the distal end of the endoscope.
These bronchovideoscopes are medical devices used in respiratory procedures. Healthcare facilities and medical professionals who use these devices should be aware of this recall and contact Olympus Corporation for further guidance.
The recalled product
- Product
- EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-P190
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 3,948
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model BF-P190 UDI-DI: 4953170342110
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 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.
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