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UPDATE: Change in Reprocessing Methods with Certain Karl Storz Urological Endoscopes - Letter to Health Care Providers
Today, the U.S. Food and Drug Administration (FDA) issued a Letter to Health Care Providers to ensure that health care providers and users are aware of the change in reprocessing methods for certain urological endoscopes manufactured 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.
The Letter to Health Care Providers includes important information about affected urological endoscopes, including:
- Recommendations for health care providers and users
- Background on the issue
- Actions that the FDA continues to take related to the risk of patient infections and contamination issues associated with reprocessed urological endoscopes
- Instructions for reporting problems with reprocessed urological endoscopes.
Questions?
If you have questions about this Letter to Health Care Providers, contact the Division of Industry and Consumer Education (DICE).
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