FDA: Automated Endoscope Reprocessors Recalled

Share this content:
FDA: Automated Endoscope Reprocessors Recalled
FDA: Automated Endoscope Reprocessors Recalled

MONDAY, Nov. 16, 2015 (HealthDay News) -- Nearly 2,800 machines used to disinfect medical scopes are being recalled because they may put patients at risk for infections, the U.S. Food and Drug Administration says.

The agency ordered Custom Ultrasonics of Warminster, Pa., to recall all its endoscope reprocessing devices, which are used at hospitals and medical clinics nationwide, the Associated Press reported. The devices are meant to clean flexible endoscopes so they can be re-used safely, but Custom Ultrasonics has a history of violating federal rules for manufacturing and quality control, the FDA said.

The recall was ordered under terms of a 2007 legal agreement with the company that forbids it from making or distributing the endoscope reprocessing devices. Custom Ultrasonics has continued to service the devices, the AP reported. However, the FDA says the company still cannot prove that its devices adequately wash and disinfect endoscopes.

Hospitals and medical clinics with the Custom Ultrasonics devices should use other endoscope cleaning machines to reduce the risk of patient infections, the FDA said. A number of dangerous bacterial outbreaks associated with medical scopes have occurred at hospitals across the U.S., the AP reported.

More Information

Share this content:

is free, fast, and customized just for you!

Already a member?

Sign In Now »


Sign up for myCME e-newsletters


Drug Lookup

Browse drugs by: BrandGenericDisease


More in Home

Dermatography Helps Lessen Appearance of Surgical Scars

Dermatography Helps Lessen Appearance of Surgical Scars

Pigments can restore more natural skin appearance that patients are happy with

Drug-Resistant Bacteria Live in America's Water Systems

Drug-Resistant Bacteria Live in America's Water Systems

Bacteria found in plumbing may sicken thousands each year

Deep Brain Stimulation May Improve TBI Symptoms

Deep Brain Stimulation May Improve TBI Symptoms

Deep brain stimulation appears to boost function and quality of life

is free, fast, and customized just for you!

Already a member?

Sign In Now »