Published by If you used CVS Wound Gel or MediHoney wound and burn products included in this removal and developed an infection or required medical care, you may want a legal review of your options.
A case evaluation can help assess potential compensation for medical expenses and other documented losses tied to the affected product.
Table Of Contents
- What’s the Problem?
- Latest Updates
- Recalled Products
- Reason for the Removal
- Where and How These Products Are Used
- Infection Risk and Symptoms
- What Consumers and Facilities Should Do
- Do You Qualify for a CVS Burn Gel Recall Lawsuit?
- Legal Theories and Liability Considerations
- Statute of Limitations
- Why Acting Promptly Matters
- References
What’s the Problem?
FDA information states packaging failures involving MediHoney wound and burn products could breach the sterile barrier. Use of a product with a breached sterile barrier could lead to patient infection, and unusable product may delay care.
FDA information also states certain CVS Wound Gel products had production and process control issues. Use of affected CVS Wound Gel may lead to infection, and inability to use the product may delay care.
Latest Updates
- January 2026 – FDA posted an early alert describing Integra LifeSciences’ removal of certain MediHoney wound and burn products and certain lots of CVS Wound Gel due to sterility and production concerns that could lead to infection, and it reported 11 serious injuries linked to MediHoney products and three serious injuries linked to CVS Wound Gel products. [1]
Recalled Products
FDA information indicates Integra LifeSciences recommended removing all MediHoney Wound and Burn products and certain lots of CVS Wound Gel. Product identification depends on the SKU/UDI and lot information listed in the FDA posting and related customer communications.
- MediHoney Wound and Burn products identified in the FDA posting, including MediHoney calcium alginate dressing products and MediHoney gel products listed by SKU/UDI
- CVS Wound Gel products identified in the FDA posting, limited to certain lots
Reason for the Removal
FDA information states the MediHoney issue involves packaging failures that could breach the sterile barrier. A breached sterile barrier increases infection risk when the product is used on burns or wounds.
FDA information states the CVS Wound Gel issue involves production and process control problems. Infection risk can exist if affected product is used on compromised skin.
Where and How These Products Are Used
FDA information states these products are used for treatment of burns and wounds. Use may involve maintaining a moist wound environment and protecting skin from breakdown or irritation.
Infection risk can be more consequential for people with burns, open wounds, or weakened immune defenses. Medical evaluation can be important if symptoms develop after exposure.
Infection Risk and Symptoms
Infection can present with increased pain, redness, swelling, warmth, drainage, fever, or delayed healing. Any rapidly worsening symptoms should be treated as urgent, especially for burns, surgical wounds, or chronic wounds.
People who already used the product should follow clinical guidance, and anyone concerned about infection should contact a healthcare provider. Product identifiers and timing can matter if testing or treatment occurs.
What Consumers and Facilities Should Do
Stop using any product that matches the affected identifiers. Remove affected product from areas where it is used or sold and follow the return or disposal instructions provided through the customer communication pathway.
Facilities may need to review traceability records to identify where affected product was shipped or used. Keeping documentation of lot numbers, purchase dates, and where product was applied can help with follow-up.
Do You Qualify for a CVS Burn Gel Recall Lawsuit?
A legal review may be relevant if CVS Wound Gel or a MediHoney wound and burn product was used and an infection occurred. Review may also be relevant if medical treatment, hospitalization, or long-term complications followed use of an affected product.
Claims are generally stronger when product identification and timing are documented. Lot and SKU information, along with medical records, often becomes central to evaluating causation.
Evidence to Gather
- Photos of the packaging showing the product name, SKU/UDI, and lot information
- Receipts, invoices, or facility supply records showing purchase and distribution
- Medical records, lab results, and treatment notes documenting infection and care
- A written timeline showing application dates and symptom onset
- Documentation of additional costs, including follow-up care and time off work
Potential Damages
Potential damages may include medical expenses, follow-up care, and related out-of-pocket costs. Depending on the facts, damages may also include lost income and compensation tied to pain, complications, or scarring.
Legal Theories and Liability Considerations
Medical product infection cases are often evaluated under product liability and negligence theories. Analysis commonly focuses on sterility controls, manufacturing processes, warnings, and whether the product reached users in an unsafe condition.
A safety removal does not automatically establish liability in an individual case. Evidence of exposure, infection, and damages still drives claim evaluation.
Statute of Limitations
Deadlines vary by state and may depend on the date of injury, diagnosis, or discovery. Preserving documentation early can help protect legal options.
Why Acting Promptly Matters
Infection claims often depend on early clinical notes, culture results, and product identifiers. Packaging and lot information can be lost quickly, so photographs and records matter.
References
- 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