Packaging failures prompt FDA alert for MediHoney and CVS wound care products
Summary: January 26, 2026 FDA alert from CDRH warns of packaging failures compromising sterility in specific MediHoney Wound and Burn products (all lots of Calcium Alginate Rope/Dressings/Gel) and CVS Wound Gel (lots 2446/2428). Integra LifeSciences reported 11 serious injuries for MediHoney and 3 for CVS as of Dec 19, 2025 (no deaths). Issues stem from production/process controls. Risks: Increased infection from non-sterile use in wounds/burns. Actions: Quarantine/remove/dispose affected products; notify distributors/customers; no additional patient follow-up needed if standard care followed. Integra issued recall notice Jan 16, 2026.
Key Highlights:
- Affected: Multiple MediHoney formats; specific CVS lots.
- Risks: Sterility breach → potential contamination/infection.
- Implications: Reminder of quality vigilance in moist-environment products like honey-based dressings.
- Relevance: Impacts common chronic wound treatments; stresses supply chain safety.
Keywords: FDA alert, MediHoney, packaging failure, sterility breach