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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 and certain lots of CVS Wound Gel be removed from where they are used or sold. [1] Integra identified packaging failures related to MediHoney products that could lead to a breach in the sterile barrier, and production and process control issues for certain CVS Wound Gel products that may lead to infection. [1]
Packaging Failures and Sterile Barrier Breaches
Integra LifeSciences identified packaging failures in MediHoney Wound and Burn products that compromise the sterile barrier protecting the wound care dressings from contamination. When sterile barriers are breached, bacteria and microorganisms can contaminate the gels and dressings, transforming wound care products into sources of infection.
Production and Process Control Issues
Integra identified production and process control issues affecting CVS Wound Gel lots 2446 and 2428 manufactured at facilities with inadequate quality controls. These production defects create the same infection risks as packaging failures, allowing contamination of products intended for treating open wounds and burns.
Affected Products
The recall includes all lots of six MediHoney Wound and Burn products and two specific CVS Wound Gel lots:
- MEDIHONEY Calcium Alginate Dress Rope, ¾” x 12″ (SKU 31012) – All lots
- MEDIHONEY Calcium Alginate Dressing, 2″ x 2″ (SKU 31022) – All lots
- MEDIHONEY Calcium Alginate Dressing, 4″ x 5″ (SKU 31045) – All lots
- MEDIHONEY Gel in Tube, 0.5 fl oz Twistoff Sterile (SKU 31805) – All lots
- MEDIHONEY Gel in Tube, 1.5 fl oz Flipcap Sterile (SKU 31815) – All lots
- CVS Wound Gel 1 oz Tube (SKU CVS405406) – Lots 2446 and 2428 only
Serious Injuries Reported
As of December 19, 2025, Integra reported 14 serious injuries to the FDA with no deaths. The 11 serious injuries from MediHoney products and 3 serious injuries from CVS Wound Gel lots 2446 and 2428 are consistent with wound infections introduced through compromised sterile packaging.
Patients suffering from burns, chronic wounds, or post-surgical sites are especially vulnerable to infections from contaminated wound care products. These vulnerable populations experience more severe complications when non-sterile products introduce bacteria to already compromised tissue.
Infection Risks
Use of products with breached sterile barriers can lead to patient infections ranging from minor wound complications to life-threatening sepsis. Contaminated wound gels and dressings applied to open burns and wounds introduce bacteria directly into injured tissue where immune defenses are already compromised.
Packaging failures may also delay care when healthcare providers and patients cannot use defective devices due to obviously damaged or compromised packaging. Delayed wound treatment increases infection risks and can worsen patient outcomes.
Device Uses and Patient Populations
MediHoney Wound and Burn products and CVS Wound Gel treat burns and wounds by maintaining moist wound environments, protecting skin from breakdown and irritation, and preventing additional damage during healing. These products are used in hospitals, clinics, nursing homes, and home care settings for patients with surgical wounds, diabetic ulcers, pressure sores, burns, and chronic wounds.
FDA Classification
The FDA classified this issue as a Class II Recall on March 6, 2026. Class II recalls involve devices that may cause temporary or reversible health problems, or where the probability of serious health problems is remote.
Manufacturing Defects
Integra’s packaging failures and production control issues represent fundamental manufacturing defects that allowed non-sterile wound care products to reach consumers. The company failed to implement adequate quality control measures to ensure sterile barrier integrity and proper production processes before distributing products nationwide.
Legal Claims
Strict products liability claims allege Integra manufactured and sold defective wound care devices with compromised sterile barriers that pose unreasonable infection dangers. Manufacturing defect claims assert packaging failures and production control issues created products that deviate from design specifications and industry sterility standards.
Negligence claims allege Integra breached its duty to implement adequate quality control testing to detect sterile barrier breaches and production defects before distribution. Failure to warn claims assert Integra failed to immediately notify healthcare providers and consumers about infection risks from compromised wound care products.
Personal Injury Claims
Patients who developed infections from recalled MediHoney or CVS Wound Gel products may recover damages for medical expenses, hospitalization costs, additional wound care treatments, lost wages, pain and suffering, and permanent scarring. Severe infections requiring surgical debridement, prolonged antibiotic therapy, or resulting in sepsis create substantial medical costs and long-term complications.
Medical Monitoring
Patients who used recalled products but have not yet developed infections may seek medical monitoring damages for ongoing surveillance and testing. Some bacterial infections have delayed onset or create chronic complications requiring long-term medical oversight.
Economic Loss
Healthcare facilities, clinics, and consumers who purchased recalled wound care products suffered economic losses from buying defective medical devices. Even without experiencing infections, purchasers paid for sterile wound care products but received contaminated devices requiring disposal and replacement.
Contact an Attorney
If you developed a wound infection after using recalled MediHoney Wound and Burn products or CVS Wound Gel lots 2446 or 2428, contact a product liability attorney immediately. Preserve product packaging, purchase receipts, medical records documenting infections and treatments, and all communications with Integra LifeSciences.
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