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November 16, 2015: Custom Ultrasonics Automated Endoscope Reprocessors Recall Ordered by FDA

On November 16, 2015, Custom Ultrasonics was ordered by the U.S. Food and Drug Administration (FDA) to recall all of its automated endoscope reprocessors (AERs). The recall entails removal of all automated endoscope reprocessors from health care facilities due to an increased risk of infection transmission from the device.
The AER recall was initiated due to Custom Ultrasonic’s repeated violations of FDA orders, specifically the company’s agreement to follow the stipulations of a consent decree they entered into with the FDA in 2007. The consent decree was entered as a settlement between the FDA and Custom Ultrasonics in order to resolve a dispute without admission of guilt on the company’s part.

The conditions of the decree entailed that Ultrasonics would not manufacture or distribute its automated endoscope reprocessors until the methods and controls used to manufacture the devices were into compliance with FDA’s Current Good Manufacturing Practice requirements of its Quality System (QS) regulation.

For more information about the FDA’s Manufacturing Practice Requirements visit Medical Devices: Current Good Manufacturing Practice, Quality System Regulation.

FDA Statement on Automated Endoscope Reprocessors Recall

William Maisel, M.D., M.P.H., deputy director for science and chief scientist in the FDA’s Center for Devices and Radiological Health reiterated the importance of the Automated Endoscope Reprocessors Recall, stating “We are taking action because Custom Ultrasonics failed to meet its legal and regulatory obligations,” adding, “The FDA’s recall order […] is necessary to protect the public health.”

As the original 2007 Consent Decree explains, “The company’s actions posed a potential public health hazard because endoscopes that are not properly cleaned and disinfected can be a source of transmission of pathogens between patients, causing life threatening infections.”

To see the 2007 Consent Decree Agreement Between Custom Ultrasonics and the FDA, visit Custom Ultrasonics Signs Consent Decree.

The Use of Automated Endoscope Reprocessors

According to the U.S. National Library of Medicine, endoscopes are devices used to look inside a body cavity or organ. The scope is inserted through a natural opening, such as the mouth during a bronchoscopy, or the rectum for a sigmoidoscopy.. At the tip of the scope is a movable “elevator” mechanism that allows the change of angle as instruments are passed through the scope during a procedure. According to the FDA, this movable feature can add to the challenge of cleaning and disinfecting these reusable devices.

As the FDA press announcement explains, “Automated Endoscope Reprocessors are used to wash and high-level disinfect endoscopes to decontaminate them between uses […] in order to kill microorganisms and prevent the spread of infection from these reusable medical devices. To date, Custom Ultrasonics has not demonstrated that its AERs can adequately wash and disinfect endoscopes to mitigate the risk of patient infection.”


The Weinberg Law Firm is currently accepting endoscope-linked infection personal injury cases nationwide. If you or someone you know has suffered a CRE infection (also called a “Superbug Infection”) after undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP) with a reprocessed endoscope, please contact our firm toll free at 1-877-934-6274 for a free legal case evaluation. You can also visit our Endoscope/Duodenoscope Infection Lawsuit Help page to contact one of our lawyers.

If you have a case-specific question, or a question regarding our legal services, please select
Contact Weinberg Law Firm. You may also call us 24/7 at our toll free number, 1(877) 934-6274.