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U.S. Department of Health and Human Services

Safety

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Human Tissue Processed by Cryolife, Inc.

Audience: Surgeons and other healthcare professionals

FDA notified healthcare professionals that Cryolife, a human tissue-processing firm, was ordered to recall all distributed human allograft tissues, except allograft heart valves, that have been processed by Cryolife since October 3, 2001. This FDA recall order was issued after FDA discovered regulatory violations related to the processing of human tissue by Cryolife, documented fungal and bacterial contamination of Cryolife tissues, and found that Cryolife had not fully implemented adequate corrective actions.

[August 21, 2002 - Public Health Notification - FDA]