Olympus Bronchovideoscope Recalled Due to Combustion Risk
Olympus is recalling 719 EVIS EXERA b Bronchovideoscope Model BF-XT190 devices due to risk of endobronchial combustion during high-frequency cauterization when oxygen is supplied or the electrode is too close to the device tip.
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 establishes a minimum severity level of 4 per regulatory guidelines. The hazard—risk of endobronchial combustion during routine clinical procedures—poses serious risk of internal thermal injury to patients.
Plain-English summary
Olympus Corporation of the Americas is recalling approximately 719 units of the EVIS EXERA b BRONCHOVIDEOSCOPE Model BF-XT190 nationwide. The affected devices are identified by UDI-DI: 4953170402470.
The recall is due to risk of endobronchial combustion (internal burning within the airway). This risk occurs when high-frequency cauterization (surgical burning) is performed while oxygen is supplied to the patient, or when the electrode section of the electrosurgical accessory is positioned too close to the distal end (tip) of the endoscope.
The devices were distributed to healthcare facilities nationwide. This recall is classified as FDA Class I, indicating a serious potential health hazard.
The recalled product
- Product
- EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-XT190
- Manufacturer
- Olympus Corporation of the Americas
- Hazard
- Affected units
- 719
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-XT190 UDI-DI: 4953170402470
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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