FDA Issues a Class 1 Recall on Nidek Medical Products, Inc.'s Oxygen Concentrators
Published: Jun 20, 2012
Nidek Medical Products, Inc. recalled their Medical Mark5 Nuvo Lite Oxygen concentrators for instances of failure causing fire. Nidek Medical Products, Inc., today announced that the US Food and Drug Administration has classified the company’s voluntary recall of Medical Mark5 Nuvo Lite Oxygen concentrators as a Class I recall. The devices were recalled due to capacitor-related fires. According to the FDA, a capacitor component inside the concentrators were, in some instances, found to fail, which has caused residential and nursing home fires, and a loss of oxygen supply.