2015-11-16 20:40:06 UTC

FDA Warning: Stop Using Custom Ultrasonics' Automated Endoscope Reprocessors

Nov. 17, 2015

FDA has issued a recall of the 2,800 AERs manufactured by Custom Ultrasonics currently in use in the U.S.

Due to violations that could result in an increased risk of infection transmission, FDA has ordered Custom Ultrasonics to recall all of its automated endoscope reprocessors (AERs) from health-care facilities. If you are currently using Custom Ultrasonics' AERs, FDA recommends you transition away from their use to alternative methods to reprocess flexible endoscopes as soon as possible. 

FDA advises health-care facilities currently using Custom Ultrasonics' AERs to:

  • Identify and transition to alternate methods to reprocess flexible endoscopes, such as manual high-level disinfection, liquid chemical sterilization, alternative AERs or other cleaning and sterilization methods according to the endoscope manufacturer’s reprocessing instructions.
  • Before transitioning to an alternative method, verify that the endoscopes used by the facility are compatible with the alternative method by referring to the endoscope manufacturer’s reprocessing instructions.
  • Submit a report to Custom Ultrasonics and to FDA via MedWatch if your health-care facility suspects that a Custom Ultrasonics AER has caused or contributed to patient infection.

An estimated 2,800 AERs manufactured by Custom Ultrasonics are currently in hospitals and outpatient clinics throughout the U.S. FDA’s recall order applies to all Custom Ultrasonics' AERs, including the System 83 Plus, System 83 Plus 2 and System 83 Plus 9. Custom Ultrasonics is required to provide a written recall proposal to FDA this week — additional information and next steps will be available at that time.

This recall is based on both the recent violations of the law and consent decree and reports that endoscopes reprocessed by Custom Ultrasonics' AERs have been used in health-care facilities that reported the transmission of serious bacterial infections.

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