FDA Announces Recall for MediHoney and CVS Wound Care Products Due to Sterility Concerns
Summary: The U.S. Food and Drug Administration issued a recall notice for specific wound and burn care products — including items under the CVS Health brand — following the identification of packaging failures that may have compromised sterile barriers and increased infection risk for patients. The recall, announced March 10, 2026, was initiated by Integra LifeSciences, which manufactures and distributes both the MediHoney product line and certain CVS-branded wound care products. Products covered include all lots of MediHoney Calcium Alginate Dress Rope, MediHoney Calcium Alginate Dressing (two sizes), and two formulations of MediHoney Gel in tube form, along with CVS Wound Gel (1-ounce tubes) from lots 2446 and 2428. Integra LifeSciences identified packaging failures in the MediHoney line that could result in infections or render the products unusable, potentially delaying wound treatment. Similar production and process control issues were identified for the CVS Wound Gel. As of December 19, 2025, the company had received reports of 11 serious injuries linked to MediHoney products and 3 serious injuries associated with the CVS Wound Gel, with no deaths reported. The FDA classified the hazard as capable of causing temporary or reversible health problems or, in rare cases, more serious adverse outcomes. Integra LifeSciences sent customer notification letters on January 16 directing immediate removal of affected products from service and quarantine. Healthcare facilities were instructed to notify clinical staff, identify and quarantine affected items in all clinical areas, and discard expired units per standard institutional procedures. Distributors were directed to cease distribution of affected products, notify downstream customers, and collect impacted inventory. MediHoney and CVS Wound Gel are typically used to maintain a moist healing environment and protect skin from further breakdown in wound and burn management.
Key Highlights:
- Recall initiated by Integra LifeSciences — covers MediHoney Calcium Alginate products (two sizes), MediHoney Gel (two formulations), and CVS Wound Gel lots 2446 and 2428; all used for moist wound healing and skin protection
- Cause: packaging failures that may compromise the sterile barrier — raising infection risk or rendering products unusable; both manufacturing process issues (MediHoney) and production/process control issues (CVS Wound Gel) identified
- Adverse events as of December 19, 2025: 11 serious injuries linked to MediHoney; 3 serious injuries linked to CVS Wound Gel; no deaths reported
- FDA classification: products could cause temporary or reversible health problems or, in rare cases, more serious medical complications
- Immediate action required for healthcare facilities: remove all affected product lots from clinical service, quarantine them, notify all relevant clinical staff, and discard expired units per standard procedures
- Distributor action required: immediately cease distribution of recalled lots, notify all customers, and collect impacted inventory — customers must not use affected products under any circumstances
Keywords: FDA wound care recall, MediHoney recall sterility, Integra LifeSciences recall, CVS wound gel recall, wound dressing sterility failure, medical device recall wound care
Integra LifeSciences