FDA orders recall of machine used to clean medical scopes

The agency ordered the action under terms of a 2007 legal settlement with the company. The settlement bars the firm from making or distributing the machines. Custom Ultrasonics has continued to service the machines.

But FDA inspectors uncovered ongoing problems with the company's technology during an April inspection. Inspectors said the company still cannot show that its devices adequately wash and disinfect endoscopes.

"The FDA's recall order stemmed from the company's continued violations of federal law and the consent decree and is necessary to protect the public health," said Dr. William Maisel, the FDA's deputy director for medical devices.

A consent decree is a form of legal settlement in which a company agrees to court-ordered actions without admitting fault or guilt. The decree generally remains in effect until the FDA determines the company has fixed the problems.

The FDA says hospitals and medical facilities should switch to alternate machines to avoid possible infections.

The announcement follows a series of life-threatening bacterial outbreaks that have been tied to medical scopes at hospitals across the U.S.