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Olympus Corporation of the Americas recalls BF-1T60 OES Bronchofiberscope, Model No. BF-1T60
Recalled October 6, 2021 · FDA recall Z-2567-2021 · 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
350
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-1T60 OES Bronchofiberscope, Model No. BF-1T60
Manufacturer(s)
Olympus Corporation of the Americas
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →