WASHINGTON -- The FDA has issued a class I recall for several models of oxygen concentrators because of a potential fire hazard.
A capacitor failure in the Nidek Medical Mark5 Nuvo and Nuvo Lite may cause fire and loss of supplemental oxygen, according to a statement from manufacturer Nidek Medical Products.
The recall affects devices manufactured and distributed from January 2004 to May 2010 and includes serial numbers 042-10000 to 102-09335. A full list of the 11 affected device models is available in the .
The company had not received any injury reports at the time of the recall.
The concentrators are indicated to provide supplemental oxygen in a home setting and are not considered life-support devices.
The manufacturer said it will supply replacement capacitors for affected devices.