Integra LifeSciences has announced a recall for certain MediHoney and CVS wound and burn care products that may not be sterile due to a packaging defect, which could pose a risk of serious infections.
Integra LifeSciences reported 11 serious injuries from the recalled MediHoney products and 3 additional serious injuries linked to the CVS Wound Gel as of December 19, 2025. No deaths were reported.
The recall covers the entire MediHoney Wound and Burn line as well as specific lots of CVS Wound Gel. The recalled MediHoney products include:
- MediHoney Calcium Alginate Dressing Rope (¾” x 12″, SKU 31012) — a rope-shaped dressing designed to pack into deep or cavity wounds to promote healing from the inside out
- MediHoney Calcium Alginate Dressing (2″ x 2″, SKU 31022) — a small square dressing for minor wounds, abrasions, and localized skin breakdown
- MediHoney Calcium Alginate Dressing (4″ x 5″, SKU 31045) — a larger square dressing for broader wound coverage, commonly used on burns and surgical wounds
- MediHoney Gel Tube, 0.5 fl oz Twist-Off — Sterile (SKU 31805) — a small single-use-style gel tube for applying Manuka honey-based gel directly to a wound
- MediHoney Gel Tube, 1.5 fl oz Flip Cap — Sterile (SKU 31815) — a larger gel tube for ongoing wound care treatment; the flip cap allows for repeated use
The recall also includes this CVS Wound Gel product:
- CVS Wound Gel, 1 oz Tube (SKU CVS405406, Lots 2446 and 2428) — a store-brand wound gel sold at CVS pharmacy locations; only these two specific lot numbers are affected, which can be found printed on the packaging
The FDA classified the action as a Class II Recall on March 6, 2026, meaning the products may cause temporary or reversible health problems, though more serious harm is considered unlikely.
On January 16, 2026, the company sent letters to all affected customers instructing them to immediately remove the products from service and quarantine any remaining inventory. Distributors were told to halt further distribution and contact customers. The FDA issued an Early Alert on January 22, 2026, before upgrading the recall this week.
Anyone who has already used these products and followed standard wound care practices does not need additional follow-up, according to Integra. However, patients or caregivers who suspect they used a compromised product and experienced signs of infection should contact their healthcare provider.
Consumers and healthcare professionals with questions about the recall can contact Integra LifeSciences at 1-800-654-2873 or by email at custsvcnj@integralife.com. Adverse reactions can also be reported to the FDA’s MedWatch program at FDA.gov/MedWatch.
Patients who were harmed after using recalled wound care products may have legal options and should consider speaking with a personal injury attorney.