FDA Warns on CVS Gel After Serious Injuries Reported

 The FDA warned on wound and burn care products from MediHoney and CVS after more than a dozen serious injuries were reported.

"Integra LifeSciences identified packaging failures related to the MediHoney Wound and Burn products that could lead to a breach in the sterile barrier," the FDA said, adding that "use of product with a breached sterile barrier could lead to patient infection."

Similarly, certain batches of CVS Wound Gel may also carry an infection risk.

The FDA said the inability to use the products -- which maintain a moist wound environment or protect skin from damage or irritation -- may delay needed care.

Eleven serious injuries linked to MediHoney's products and three serious injuries associated with the CVS gel have been reported as of Dec. 19, 2025, according to the agency.

Integra LifeSciences sent a letter to customers last week recommending that affected products be quarantined, disposed of if expired, and asked that its notice be forwarded so that any remaining batches of recalled product can be identified and removed from clinical areas.

Distributors should also remove affected products to ensure they are not further distributed.

https://www.medpagetoday.com/publichealthpolicy/productalert/119547