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Early Alert: Wound, Burn Dressing Issue from Integra LifeSciences
The FDA is aware that Integra LifeSciences has identified packaging failures related to all MediHoney Wound and Burn products and certain lots of CVS Wound Gel that could lead to a breach in the sterile barrier. Using products with a breached sterile barrier could lead to patient infection. The inability to use the device due to packaging failures may delay care.
As of December 19, 2025, Integra LifeSciences 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.
CDRH is issuing this Early Alert to notify the public of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.
Questions?
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Integra at 1-800-654-2873 or custsvcnj@integralife.com.
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