The federal government has ordered manufacturer Custom Ultrasonics to recall all automated endoscope reprocessors from hospitals and other health care facilties.

In announcing the recall, the Food and Drug Administration (FDA) cited an increased risk of infection transmission by the company’s equipment due to repeated violations of federal law. Hospitals and other facilities using automated endoscope reprocessors by Custom Ultrasonics should transition to alternative reprocessing methods. Also, facilities should report any infections that might be related to these reprocessors to both Custom Ultrasonics and the FDA MedWatch program.

An ECRI Institute report recently named dirty endoscopes as the top health technology hazard for patients in 2016. A series of carbapenem-resistant Enterobacteriaceae (CRE) infections in 2014 and 2015 were associated with the use of duodenoscopes that were not successfully disinfected between uses.

Contact Director of Policy Erin O’Malley at or 202.585.0127 with questions.