Published by If you used MediHoney wound and burn products included in this removal and later developed an infection or needed 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 products.
Table Of Contents
- What’s the Problem?
- Latest Updates
- Recalled Products
- How These Products Are Used
- Infection Risk and Symptoms
- What to Do If You Have the Product
- Do You Qualify for a MediHoney Burn Gel Recall Lawsuit?
- Legal Theories and Liability Considerations
- Statute of Limitations
- Why Acting Promptly Matters
- References
What’s the Problem?
Packaging failures were identified in MediHoney wound and burn products that could breach the sterile barrier. A breached sterile barrier can increase infection risk when a dressing or gel is used on burns or wounds.
Care delays can also occur when products are unusable due to packaging problems. The notice indicates that if the affected products were already used and standard operative care was followed, no additional patient follow-up is required.
Latest Updates
- January 2026 – The FDA posted an alert describing Integra LifeSciences’ removal of certain MediHoney wound and burn products due to sterile-barrier packaging failures, and it reported 11 serious injuries related to MediHoney products and no deaths. [1]
Recalled Products
The notice recommends removing all MediHoney Wound and Burn products listed below from where they are used or sold. The same notice also references certain CVS Wound Gel lots, but the MediHoney items are the focus of this page.
- 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, .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 (28.4 g), 24 cartons/case (SKU CVS405406) – lots 2446 and 2428
How These Products Are Used
MediHoney wound and burn products are used for the treatment of burns and wounds. They can help maintain a moist wound environment and protect skin from breakdown, irritation, or damage.
Because these products may be used on compromised skin, infection risk is a central safety concern. Medical evaluation is important if symptoms develop.
Infection Risk and Symptoms
Infection may present with increased redness, swelling, warmth, pain, drainage, fever, or delayed healing. Worsening symptoms after a wound or burn dressing application should be treated seriously.
People who are immunocompromised, elderly, or very young can face higher risk of complications from infection. Anyone concerned about infection should contact a healthcare provider promptly.
What to Do If You Have the Product
Do not use affected product and immediately remove it from service. Facilities and distributors should quarantine affected inventory and use traceability records to notify downstream customers.
Expired product should be discarded following facility policies and procedures. Documentation of SKU and lot details can help with follow-up and any claim evaluation.
Do You Qualify for a MediHoney Burn Gel Recall Lawsuit?
A legal review may be relevant if a MediHoney product listed above was used and an infection occurred. Review may also be appropriate if hospitalization, surgery, extended antibiotics, or other significant treatment followed.
Claim strength often depends on matching the exact product identifiers and showing a clear timeline of use and symptoms. Packaging, clinical notes, and lab results can be important.
Evidence to Gather
- Photos of the packaging showing product name, SKU/UDI, and any lot identifiers
- Receipts, invoices, or facility supply records showing purchase and distribution
- Medical records, culture results, and treatment notes documenting infection
- A written timeline of application dates and symptom onset
- Documentation of out-of-pocket costs and time away from work
Potential Damages
Potential damages may include medical expenses, follow-up care, and related out-of-pocket costs. Depending on the facts, claims may also involve lost income and compensation tied to pain, complications, or scarring.
Legal Theories and Liability Considerations
Infection-related medical product cases are often evaluated under product liability and negligence theories. Analysis commonly focuses on sterility controls, packaging integrity, and whether the product reached users in an unsafe condition.
A removal or recall notice does not automatically establish liability in an individual case. Proof of exposure, infection, causation, and damages remains central to any claim.
Statute of Limitations
Filing 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 and culture results. Product identifiers 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