Integra Recalls Wound and Burn Products Over Sterile Packaging Issues

Integra LifeSciences has issued a recall of wound and burn care products following reports of 14 serious injuries, the FDA said. The alert comes after Integra informed customers of packaging failures that compromised the sterile barrier, potentially exposing patients to infection. Most affected products belong to the MediHoney line, with some CVS Wound Gel items also included.

As of December 19, 11 injuries were linked to MediHoney and three to CVS Wound Gel, though no deaths have been reported. The problems stem from breaches in sterile packaging and production control issues, which could delay care or lead to infections. Customers and distributors are advised to quarantine and remove affected devices and dispose of expired items. Healthcare providers who used recalled products under standard protocols do not need additional patient follow-up.

Integra acquired MediHoney through its 2017 acquisition of Derma Sciences, which had previously purchased the brand from Comvita for $13.3 million.

25-01-2026