As of January 23, 2026, the FDA has issued an early alert regarding a potentially high-risk device issue with Integra LifeSciences’ MediHoney Wound and Burn products and certain lots of CVS Wound Gel.
This alert is crucial for healthcare professionals, patients, and distributors who use or sell these products.
What Changed?
Integra LifeSciences has identified packaging failures related to the MediHoney Wound and Burn products, which could lead to a breach in the sterile barrier. Additionally, production and process control issues were found with certain CVS Wound Gel products.
Reason for Early Alert
The FDA is aware of 11 serious injuries related to MediHoney Wound and Burn products and three serious injuries related to CVS Wound Gel products, with no reported deaths associated with this issue.
Affected Products
The affected products include various lots of MediHoney Wound and Burn products and CVS Wound Gel products, which are used for the treatment of burns and wounds.
Device Use
These products help maintain a moist wound environment, protect skin from breakdown and irritation, or protect the skin from damage.
What to Do
Customers are advised not to use the affected products and to immediately identify and remove them from service. Healthcare professionals and consumers can report adverse reactions or quality problems to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
Conclusion
In conclusion, the FDA’s early alert highlights the importance of monitoring medical device safety and taking prompt action when issues arise. Healthcare professionals and patients should be aware of this alert and take necessary steps to ensure patient safety.
Disclaimer
This information is not intended to be legal advice. Healthcare professionals should consult the FDA’s website for the most up-to-date information on this issue.
FDA Link
For full information about the FDA announcement, see the link below.
https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/early-alert-wound-and-burn-dressing-issue-integra-lifesciences