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Regulatory Focus™ > News Articles > FDA Reaffirms Endoscope Washer Recall After Company Tries to Correct Devices

FDA Reaffirms Endoscope Washer Recall After Company Tries to Correct Devices

Posted 24 February 2016 | By Michael Mezher 

FDA Reaffirms Endoscope Washer Recall After Company Tries to Correct Devices

The US Food and Drug Administration (FDA) has reiterated its recall of Custom Ultrasonics' automated endoscope reprocessors (AERs) after the company had proposed to correct, rather than recall the AERs, which FDA rejected as the devices fail to adequately wash and disinfect endoscopes.


Duodenoscopes are a type of endoscope manufactured and sold in the US by Fujifilm, Pentax and Olympus and are notoriously difficult to clean.

Customs Ultrasonics AERs, which are used to clean these scopes, were referenced in a recent Senate investigation into superbug outbreaks linked to duodenoscopes which uncovered more than two dozen outbreaks in the US and Europe since 2012.

The Senate report states that "FDA is so concerned about Custom Ultrasonics AERs' ability to perform as marketed that the agency deemed a mandatory recall necessary to protect the public's health."

The report also found that Custom Ultrasonics' AERs were used to clean duodenoscopes at "at least nine out of 16 domestic hospitals that experienced infections … accounting for about 141 patient infections."

Additionally, FDA has warned all three duodenoscope manufacturers for not adequately validating their cleaning and sterilization procedures and failing to report adverse events related to the devices. In October, the agency ordered the manufacturers to conduct additional studies into their cleaning processes. Since then, all three duodenoscope manufacturers have validated new reprocessing instructions for the devices (Fujifilm, Pentax, Olympus).


In 2012 and 2013, FDA ordered Custom Ultrasonics to stop marketing its AERs after it "failed to obtain FDA clearance following a significant change to the software operating system." FDA later cleared the software change, but did not lift its ban on manufacturing or distributing the devices, though it allowed the company to service existing AERs.

However, in November, FDA ordered a recall of Custom Ultrasonics' System 83 AERs after an inspection of the company's facilities revealed that it had not sufficiently validated the devices ability to clean and disinfect endoscopes. Specifically, the order called on the company to submit a proposal detailing its plan to recall all System 83 AERs and submit monthly reports to the agency to provide updates on the status of the recall operations.

Following the recall, FDA recommended that health care facilities using Custom Ultrasonics AERs use alternative methods to clean and disinfect flexible endoscopes, including manual disinfection, liquid chemical sterilization, or other methods per the manufacturer's instructions for use.

According to a letter sent to Custom Ultrasonics President and CEO Alicia Nakonetschny on 29 January, FDA received a proposal from the company to "correct [its] devices presently on the market rather than to remove those devices from use as directed by the Recall Order."

At a meeting on 11 December, FDA denied the company's proposal to correct its devices and reaffirmed its order to recall all its System 83 AERs, citing the risk of infection the devices pose. The agency said that the changes Custom Ultrasonics presented would require a new clearance via the 510(k) pathway which takes about five months on average.

FDA says the company also failed to adequately address all six violations listed in the November recall order.

The agency also warns the company that it "may seek any and all appropriate legal and equitable remedies of the Court, including, but not limited to, civil or criminal contempt."

FDA Letter

Updated Safety Communication

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