FDA

FDA issues alert on MediHoney and CVS wound care products tied to serious injuries

January 23, 2026

FDA has issued an Early Alert after Integra LifeSciences identified packaging failures affecting all MediHoney Wound and Burn products and certain lots of CVS Wound Gel. The agency reported that the failures may compromise the sterile barrier, increasing the risk of patient infection and potentially delaying care if products are unusable.

As of December 19, 2025, Integra reported 11 serious injuries associated with MediHoney products and three serious injuries linked to CVS Wound Gel; no deaths have been reported. FDA characterized the issue as potentially high risk and advised not using affected products and immediately removing them clinical and retail settings.

FDA will continue to update the alert as new information becomes available. Clinicians are encouraged to report adverse events or product quality concerns and to contact Integra LifeSciences with questions regarding affected dressings.

Source:

(2026, February 22). FDA. Early Alert: Wound and Burn Dressing Issue from Integra LifeSciences. https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/early-alert-wound-and-burn-dressing-issue-integra-lifesciences