January 26, 2026
2 min read
Key takeaways:
- The FDA issued an alert stating packaging failures compromised the sterile barrier of MediHoney Wound and Burn products and certain lots of CVS Wound Gel.
- Using these products may lead to infection.
The FDA’s Center for Devices and Radiological Health issued an early alert warning of packaging failures that could lead to a breach in the sterile barrier for MediHoney Wound and Burn products and certain lots of CVS Wound Gel.
As of Dec. 19, 2025, 11 serious injuries related to MediHoney Wound and Burn products and three serious injuries related to CVS Wound Gel products have been reported by Integra LifeScience, according to the alert. There are no deaths linked to this issue, the FDA said.
The FDA’s Center for Devices and Radiological Health issued an early alert warning of packaging failures that could lead to a breach in the sterile barrier for MediHoney Wound and Burn products and certain lots of CVS Wound Gel.
According to the alert, the manufacturer, Integra LifeSciences, has notified affected customers and recommended removal of the following products from use or sale:
- all lots of MediHoney Calcium Alginate Dress Rope, ¾” X 12”;
- all lots of MediHoney Calcium Alginate Dressing 2” X 2”;
- all lots of MediHoney Calcium Alginate Dressing 4” X 5”;all lots of MediHoney Gel In Tube, .5 Fl Oz Twistoff – Sterile;
- all lots of MediHoney Gel In Tube, 1.5 Fl Oz Flipcap – Sterile and
- lots 2446 and 2428 of CVS Wound Gel 1 Oz Tube (28.4 g) 24 cartons/case.
MediHoney Wound and Burn products, which contain manuka honey, and CVS Wound Gel products are used to treat wounds and burns by helping maintain moist wound environments and protecting the skin from breakdown, irritation and damage, according to the FDA.
Integra LifeSciences informed customers of the issue on Jan. 16, according to the alert. The manufacturer also identified production and process control issues affecting certain CVS Wound Gel products.
Using products with a breached sterile barrier could increase the risk for infection, according to the FDA.
In its letter, Integra LifeSciences told customers to remove and quarantine affected products and forward the notice to anyone who may have affected units. Customers were also advised to dispose of expired units.
The manufacturer urged distributors to identify and remove affected products from their shelves, notify customers of any shipments containing the affected lots and collect complete response forms from customers who have reported further information. The FDA is urging the public not to use the affected products.
Clinicians who have used these products and followed standard operative care do not need to perform additional patient follow-up, according to the agency.
Perspective
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The recent FDA alert involving packaging failures in MediHoney Wound and Burn products and CVS Wound Gel is a helpful reminder that even familiar wound care products can pose a risk when sterility is compromised. If the sterile barrier is breached, the chance of contamination and infection goes up.
For routine postsurgical wounds that are clean and not infected, my standard recommendation is simple: Keep the wound moist with plain petrolatum jelly under a nonadherent dressing. One practical tip I share with patients is to use a new, previously unopened container of petrolatum (such as Vaseline), since repeatedly dipping into an old jar can increase contamination risk. Hydrocolloid dressings are also an effective alternative and often stay in place for up to a week, making wound care easier while supporting moist healing.
If I am concerned about early superficial infection, I typically recommend a prescription topical antibiotic such as mupirocin. I do not recommend over-the-counter bacitracin, neomycin or similar “triple antibiotic” products, as allergic contact dermatitis and irritation are common and can complicate healing.
It is also important for patients to ask their physician whether an oral antibiotic is needed since deeper infections are not adequately treated with topical therapy alone.
Honey-based dressings have some evidence supporting antimicrobial and anti-inflammatory activity in certain settings, particularly for burns and select chronic wounds. However, results vary by wound type and product formulation. Further, potential downsides to using honey include allergic reactions, increased drainage, maceration and contamination risk associated with non-medical-grade honey. For most uncomplicated surgical wounds, honey is not my first-line recommendation, although I understand its appeal for patients seeking “natural” options. There is a place for it in wound care as long as sterile medical-grade products are used appropriately.
Syril Keena T. Que, MD, MPH, FAAD, FACMS
Disclosures: Que reports no relevant financial disclosures.
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