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The FDA issued an Early Alert on January 22, 2026 after Integra LifeSciences sent letters to affected customers on January 16 recommending that all MediHoney Wound and Burn products be removed from where they are used or sold. [1] Integra identified packaging failures related to MediHoney Wound and Burn products that could lead to a breach in the sterile barrier, and use of product with a breached sterile barrier could lead to patient infection. [1]
Sterile Barrier Packaging Failures
Integra LifeSciences identified packaging failures in MediHoney Wound and Burn products that compromise the sterile barriers protecting wound care devices from contamination during storage and distribution. These packaging defects allow bacteria, fungi, and other microorganisms to penetrate supposedly sterile products before they reach patients.
When sterile barriers fail, wound care products become contaminated with environmental pathogens. Patients and healthcare providers relying on sterile MediHoney products unknowingly apply bacteria-laden gels and dressings directly to open wounds and burns, creating serious infection risks.
All MediHoney Lots Recalled
The recall affects all lots of five MediHoney Wound and Burn products manufactured and distributed by Integra LifeSciences:
- MEDIHONEY Calcium Alginate Dress Rope, ¾” x 12″ (SKU 31012, UDI-DI 10381780486909) – All lots
- MEDIHONEY Calcium Alginate Dressing, 2″ x 2″ (SKU 31022, UDI-DI 10381780486916) – All lots
- MEDIHONEY Calcium Alginate Dressing, 4″ x 5″ (SKU 31045, UDI-DI 10381780486923) – All lots
- MEDIHONEY Gel in Tube, 0.5 fl oz Twistoff Sterile (SKU 31805, UDI-DI 10381780486978) – All lots
- MEDIHONEY Gel in Tube, 1.5 fl oz Flipcap Sterile (SKU 31815, UDI-DI 10381780486886) – All lots
Eleven Serious Injuries Reported
As of December 19, 2025, Integra reported 11 serious injuries to the FDA related to MediHoney Wound and Burn products, with no deaths. The serious injuries are consistent with wound infections introduced through compromised sterile packaging that allowed bacterial contamination of supposedly sterile wound care devices.
Patients using MediHoney products on burns, surgical wounds, diabetic ulcers, pressure sores, and chronic wounds experienced infections from contaminated dressings and gels. These vulnerable patient populations suffer more severe complications when non-sterile products introduce bacteria into already compromised tissue.
Infection and Delayed Care Risks
Use of MediHoney products with breached sterile barriers leads to patient infections ranging from localized wound complications to systemic sepsis requiring hospitalization. Contaminated wound gels and dressings applied directly to open injuries introduce pathogenic bacteria where immune defenses are weakest.
Packaging failures may also prevent device use when healthcare providers or patients identify obviously damaged or compromised packaging. The inability to use devices due to packaging failures delays necessary wound care and increases infection risks from untreated injuries.
Device Uses and Applications
MediHoney Wound and Burn products treat burns and wounds by maintaining moist wound environments that promote healing, protecting skin from breakdown and irritation, and preventing additional damage. Healthcare facilities use these products for surgical wound care, burn treatment units, diabetic wound clinics, and nursing home pressure ulcer management.
Home care patients also rely on MediHoney products for chronic wound management under medical supervision. The recall affects hospitals, outpatient clinics, long-term care facilities, wound care centers, and individual patients managing wounds at home.
FDA Class II Recall Classification
The FDA classified this issue as a Class II Recall on March 6, 2026, indicating devices that may cause temporary or reversible health problems. However, infections from contaminated wound care products can cause permanent complications including sepsis, tissue necrosis requiring surgical debridement, chronic osteomyelitis, and long-term antibiotic-resistant infections.
Manufacturing and Quality Control Failures
The packaging failures affecting all MediHoney lots demonstrate systemic manufacturing and quality control defects in Integra’s production processes. The company failed to ensure sterile barrier integrity across its entire MediHoney product line before distributing wound care devices to healthcare facilities and patients nationwide.
Integra’s inability to identify and correct packaging failures before distribution shows inadequate quality assurance testing and inspection protocols. Proper manufacturing controls require sterile barrier integrity testing for medical devices where contamination poses serious patient safety risks.
Legal Claims
Strict products liability claims allege Integra manufactured and sold defective MediHoney wound care devices with compromised sterile barriers that create unreasonable infection dangers for burn and wound patients. Design defect claims assert the packaging system is inherently flawed and incapable of maintaining sterile barriers throughout distribution and storage.
Manufacturing defect claims allege packaging failures created products that deviate from Integra’s design specifications and FDA requirements for sterile medical device packaging. Negligence claims assert Integra breached its duty to implement adequate quality control systems to detect sterile barrier breaches before distributing contaminated wound care products.
Failure to Warn
Failure to warn claims allege Integra knew or should have known about packaging failures creating infection risks but failed to promptly notify healthcare providers and patients. The delay between identifying packaging defects and issuing recall notices allowed continued use of contaminated products and additional patient injuries.
Personal Injury and Medical Expenses
Patients who developed infections from recalled MediHoney products may recover damages for medical expenses including hospitalization, surgical procedures, intravenous antibiotics, wound debridement, prolonged wound care, and infection treatment costs. Additional damages include lost wages from extended recovery periods, pain and suffering from infection complications, and permanent scarring or disfigurement.
Wrongful Death Claims
Although no deaths have been reported as of December 2025, families of patients who die from infections traceable to contaminated MediHoney products may pursue wrongful death claims. Sepsis and systemic infections from contaminated wound care devices can prove fatal in elderly, immunocompromised, or critically ill patients.
Economic Loss and Healthcare Facility Claims
Healthcare facilities, clinics, and wound care centers that purchased recalled MediHoney products suffered economic losses from buying defective medical devices requiring disposal and replacement. Facilities also incurred costs for identifying affected products, notifying patients, quarantining inventory, and implementing recall procedures.
Contact an Attorney
If you developed a wound or burn infection after using recalled MediHoney Wound and Burn products, contact a product liability attorney immediately. Preserve product packaging with lot numbers, purchase receipts, medical records documenting infections and treatments, and all communications with Integra LifeSciences or healthcare providers.
References
1. https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/wound-and-burn-dressing-recall-integra-lifesciences-removes-certain-medihoney-and-cvs-wound-and-burn