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Olympus Corporation of the Americas recalls EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160
Recalled September 29, 2021 · FDA recall Z-2497-2021 · Olympus Corporation of the Americas
Hazard
A gluing step was not performed during the manufacturing of the affected device's insertion tube. There is a potential for the insertion tube to develop a leak, which poses an infection control risk. · FDA Class II
Units
27 globally (21 US)
Sold at
US Nationwide distribution in the states of CA, IL, MA, MD, MI, NY, OH, OR, and PA.
Description
A gluing step was not performed during the manufacturing of the affected device's insertion tube. There is a potential for the insertion tube to develop a leak, which poses an infection control risk.
Product
EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160
Manufacturer(s)
Olympus Corporation of the Americas
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →