FDA Seeks Recall of Ozone Generators

The U.S. Food and Drug Administration has requested that Auburn, Calif.-based Applied Ozone Systems recall its AOS-1M Ozone Generator and AOS-1MD Ozone Generator devices, according to the agency.

The recall letter, dated Dec. 21, 2009, said that the FDA found the ozone generators are unapproved medical devices and that they could cause “serious adverse health consequences or death.”

During an October 2009 FDA inspection, the agency told Applied Zone Systems that it had not received clearance from the agency for the company’s devices, which the company claims treat cancer, AIDS, hepatitis, herpes and other diseases.