Wound care products, including some sold at CVS, linked to serious injuries; Here’s what’s been recalled.

WASHINGTON — The U.S. Food and Drug Administration has issued a recall notice for certain wound and burn care products, including some sold at CVS stores across the country, because they may not be sterile. 

According to the recall notice published Friday by the FDA, some products made by Integra LifeSciences, including those sold under the “CVS Health” brand, were being recalled after reports of packaging failures that could increase the risk of infection. The recall affects some MediHoney Wound and Burn dressings and certain lots of CVS Wound Gel. 

It’s unclear exactly how many products are affected by the recall. 

The recall applies to the following wound and burn care products. All listed MediHoney products include all lot numbers, while the CVS product affects specific lots:

• MediHoney Calcium Alginate Dress Rope, ¾ inch x 12 inch

  • SKU: 31012

  • UDI-DI: 10381780486909

  • Lots: All

• MediHoney Calcium Alginate Dressing, 2 inch x 2 inch

  • SKU: 31022

  • UDI-DI: 10381780486916

  • Lots: All

• MediHoney Calcium Alginate Dressing, 4 inch x 5 inch

  • SKU: 31045

  • UDI-DI: 10381780486923

  • Lots: All

• MediHoney Gel in Tube, 0.5 fl oz Twist-Off (Sterile)

  • SKU: 31805

  • UDI-DI: 10381780486978

  • Lots: All

• MediHoney Gel in Tube, 1.5 fl oz Flip-Cap (Sterile)

  • SKU: 31815

  • UDI-DI: 10381780486886

  • Lots: All

• CVS Wound Gel, 1 oz Tube (28.4 g), 24 cartons per case

  • SKU: CVS405406

  • UDI-DI: 00050428452547

  • Lots: 2446, 2428

The FDA said the devices may cause temporary or reversible health problems or, though unlikely, more serious health issues.

Integra LifeSciences said it identified packaging failures in MediHoney wound and burn products that could compromise the sterile barrier. If the sterile barrier is breached, patients may face a higher risk of infection. In some cases, the packaging defect may also make the product unusable and delay treatment.

The company also identified production and process control issues affecting certain CVS Wound Gel products. If those products are used, they could similarly lead to infections or may not function properly because of packaging problems.

As of Dec. 19, 2025, the company reported 11 serious injuries linked to MediHoney wound and burn products and three serious injuries associated with CVS Wound Gel. No deaths have been reported.

The products are used to treat burns and wounds by helping maintain a moist healing environment, protecting skin from irritation or breakdown and preventing further damage.

Integra LifeSciences sent a letter to affected customers on Jan. 16 recommending that users immediately remove impacted products from service and quarantine them.

Health care facilities were advised to notify staff who use the products so they can identify affected items in clinical areas. Expired units should be discarded according to facility procedures and should not be used.

Distributors were instructed to stop distributing the affected products, notify customers who may have received them and collect response forms and impacted inventory.

The FDA said customers should not use the affected products and should remove them from service immediately.