FDA (Devices) recall action 92362
The FDA (Devices) publishes a recall like this one as 7 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 7 pages.
There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Olympus BRONCHOVIDEOSCOPE Model BF-Q170 is recalled nationally due to complaints of endobronchial combustion during therapeutic laser procedures, classified as FDA Class I.
Olympus is recalling OES Bronchofiberscope models due to reports of combustion during laser procedures. This poses a serious burn injury risk to patients.
Olympus is recalling 9 bronchoscopes (Models BF-P150 and BF-1T150) due to complaints of endobronchial combustion during therapeutic laser procedures. The defect could cause fire and serious burn injuries.
Olympus bronchoscopes (Models BF-PE2 and BF-TE2) are recalled due to reports of combustion inside the airway during laser-assisted medical procedures. This is an FDA Class I recall.
Olympus is recalling 17,609 bronchovideoscope units nationwide due to complaints of endobronchial combustion during therapeutic laser procedures, which poses a fire and burn risk to patients.
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 FDA recalls 284 Olympus EVIS EXERA bronchoscopes due to complaints of combustion during therapeutic laser procedures. Users should stop using affected models immediately.