FDA aware of Integra recommending removal of MediHoney and Burn products

The FDA’s Center for Devices and Radiological Health issued an alert yesterday, saying it is aware that Integra LifeSciences (IART) has issued a letter to affected customers recommending all MediHoney Wound and Burn products and certain lots of CVS Wound Gel (CVS) be removed from where they are used or sold. “Do not use affected product,” the FDA said. “Immediately identify and remove affected product from service.” Integra LifeSciences identified packaging failures related to the MediHoney Wound and Burn products that could lead to a breach in the sterile barrier. As of December 19, 2025, Integra has reported 11 serious injuries related to MediHoney Wound and Burn products, three serious injuries related to CVS Wound Gel products, and no deaths associated with this issue.