Change in Reprocessing Methods with Certain Urological Endoscopes – Regulatory Compliance

The FDA has issued a letter to healthcare providers regarding possible contamination issues with reprocessed urological endoscopes manufactured by Karl Storz. The affected urological endoscopes include cystoscopes, ureteroscopes, cystourethroscopes and ureterorenoscopes, used for viewing and accessing the urinary tract. Reprocessing instructions for these urological endoscopes have been found to be inadequate and are being updated by Karl Storz.

On April 1, 2022, Karl Storz 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.

Please reach out to the C&A team with further questions or for assistance with your regulatory compliance needs.

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