Editor's Note

The Food and Drug Administration (FDA) on November 13 ordered Custom Ultrasonics (Ivyland, Pennsylvania) to recall all of its automated endoscope reprocessors from healthcare facilities because of federal law violations and a consent decree entered with the company in 2007.

The violations could result in an increased risk of infection transmission, the FDA says.

An estimated 2,800 automated endoscope reprocessors manufactured by Custom Ultrasonics are currently in use in the US.

The U.S. Food and Drug Administration today ordered Custom Ultrasonics to recall all of its automated endoscope reprocessors (AERs) from health care facilities due to the firm's continued violations of federal law and a Consent Decree entered with the company in 2007. The identified violations could result in an increased risk of infection transmission.