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U.S. Department of Health and Human Services

Medical Devices

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Information About STERIS System 1

Updated December 22, 2011: Health Care Facilities Must Replace their Steris SS1s

STERIS Corporation (STERIS) has significantly modified the SS1, and FDA has not approved or cleared this modified product. Thus, FDA has not determined whether the SS1 is safe or effective for its labeled claims, including claims that it sterilizes medical devices.

This page lists the documents that explain this situation. It will be updated as new information becomes available.


FDA Warning Letters about Steris System 1 (SS1)