FDA Provides Update on Urological Endoscope Recall

The FDA has issued on update on Karl Storz’s April 1 recall of its flexible urological endoscopes.

Testing has shown that if users perform “manual high-level disinfection,” they won’t achieve the required level of disinfection, which can increase the risk of patients contracting infections, the agency said.

The single-channel endoscopes, which are intended for various diagnostic and therapeutic uses, include instructions for recommended methods of disinfection and liquid-chemical sterilization. But customers who don’t have access to an appropriate sterilization method recommended in the instructions for use should stop using the devices and return them to the manufacturer, the FDA said.