Change in Reprocessing Methods with Certain Karl Storz Urological Endoscopes

4/4/22 — Following FDA reports about patient infections and possible contamination issues with reprocessed urological endoscopes, Karl Storz identified reprocessing failures following high-level disinfection. The company initiated a voluntary recall and issued an urgent field safety notice to instruct users to discontinue all high-level disinfection methods for all affected urological endoscopes and discontinue liquid chemical sterilization for most of the affected urological endoscopes. The affected urological endoscopes should be sterilized after each use by an appropriate sterilization method recommended in the instructions for use. Read the FDA letter to Healthcare Providers.