The company recalled various cystoscopes, ureteroscopes, cystourethroscopes and ureterorenoscopes April 1 after identifying several reprocessing issues. Karl Storz is instructing healthcare providers to discontinue all high-level disinfection methods for the endoscopes. Liquid chemical sterilization should also not be used for some devices.
“The FDA will continue to work with Karl Storz to evaluate the root cause of reprocessing failures and to ensure that an adequate supply of urological endoscopes are available for users and patient care,” the agency said.
The company will also provide updated sterilization instructions for affected endoscopes.
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