Olympus EVIS EXERA II BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-P180, BF-Q180, BF-Q180-AC, BF-1T180, BF-1TQ180 — FDA record Z-2016-2023

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Jun 8, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product
Olympus EVIS EXERA II BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-P180, BF-Q180, BF-Q180-AC, BF-1T180, BF-1TQ180
Reason
There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.
Classification
Class I
Recalling firm
Olympus Corporation of the Americas
Quantity
17,609 units
Agency-reported status
Ongoing
Source record identifier
Z-2016-2023

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label fieldDetails supplied by the agency
Lot, code or applicabilityAll serial numbers BF-P180* EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P180 UDI: 04953170339288 BF-Q180** EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180 UDI: 04953170339301 BF-Q180-AC* EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180-AC UDI: 04953170340086 BF-1T180* EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T180 UDI: 04953170339325 BF-1TQ180* EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1TQ180 UDI: 04953170339349

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

US Nationwide Distribution.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date
Jul 26, 2023
Recall initiation date
Jun 8, 2023
Center classification date
Jul 17, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

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