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Olympus Corporation of the Americas recalls BF-P180 EVIS EXERA II Bronchovideoscope, Model No. BF-P180
Recalled October 6, 2021 · FDA recall Z-2571-2021 · Olympus Corporation of the Americas
Hazard
The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling." · FDA Class II
Units
1177
Sold at
Domestic distribution nationwide. Product also distributed globally.
Description
The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
Product
BF-P180 EVIS EXERA II Bronchovideoscope, Model No. BF-P180
Manufacturer(s)
Olympus Corporation of the Americas
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →