The FDA’s Center for Devices and Radiological Health has issued an early alert warning of a potentially high-risk device issue involving certain wound and burn care products made by Integra LifeSciences Holdings Corporation (NASDAQ:IART), citing risks of infection tied to packaging and production failures.
Products Affected
According to the FDA website, Integra has notified affected customers and recommended the removal of all MediHoney Wound and Burn products, along with specific lots of CVS Wound Gel, from clinical use and retail settings.
The agency said it will continue to update the public as new information becomes available.
MediHoney Wound and Burn products and CVS Wound Gel are commonly used to treat burns and wounds.
They are designed to help maintain a moist wound environment, protect skin from irritation and breakdown, and reduce the risk of further damage during healing.
Packaging and Production Failures
Integra identified packaging failures in MediHoney Wound and Burn products that could compromise the sterile barrier. The FDA warned that use of a product with a breached sterile barrier could expose patients to infection.
In some cases, packaging failures could also prevent the product from being used, potentially delaying care. The agency said no additional patient follow-up is required if affected products were already used and standard operative care was followed.
For certain CVS Wound Gel products, Integra reported production and process control issues. If these products are used, the FDA said they may also pose an infection risk. Packaging failures could similarly limit the ability to use the device as intended.
Reported Injuries
As of December 19, 2025, Integra reported 11 serious injuries linked to MediHoney Wound and Burn products and three serious injuries associated with CVS Wound Gel products. No deaths have been reported in connection with the issue.
The FDA advised health care providers and users to immediately stop using affected products and remove them from service.
Integra sent letters to customers on January 16 outlining steps to quarantine impacted units, notify clinical staff, discard expired products per facility procedures, and ensure recalled items are not used.
Distributors were instructed to halt further distribution, notify customers, collect response forms and affected products, and manage customer communications directly, as Integra said it will route end users back to distributors for assistance.
IART Price Action: Integra Lifesciences shares were down 1.89% at $11.96 at the time of publication on Friday, according to Benzinga Pro data.
Photo by Tada Images via Shutterstock
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