CDRH is issuing this Early Alert to notify the public of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.

Affected Product

The FDA is aware that Integra LifeSciences has issued a letter to affected customers recommending all MediHoney Wound and Burn products and certain lots of CVS Wound Gel be removed from where they are used or sold.

Affected devices:

What to Do

Do not use affected product. Immediately identify and remove affected product from service.

On January 16, Integra LifeSciences sent all affected customers a letter recommending the following actions:

• If you have units of the impacted product remove them immediately from service and quarantine them.
• Forward this notice to those who utilize the product so they are aware of this recall and can identify any affected product that may remain in clinical areas.
• If you have expired products, please ensure that you discard them per your facility’s policies and procedures and that you do not use them.
• For Distributors:
  • Identify and remove affected product from further distribution.
  • Check your customer traceability records and notify them if they have any shipments of above catalog numbers.
  • Modify the acknowledgement form to create one from you to your customers.
  • Collect completed response forms and affected product from your customers and indicate total quantities and lots in distributor reply form.
  • Do not send the distributor form to your customers. Integra LifeSciences will not be able to directly assist your customers and will direct them back to you.

Check this web page for updates. The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.

Reason for Early Alert

Integra LifeSciences identified packaging failures related to the MediHoney Wound and Burn products that could lead to a breach in the sterile barrier. Use of product with a breached sterile barrier could lead to patient infection. The inability to use the device due to packaging failures may delay care. If you have already used the products affected by this recall and standard operative care was followed, there is no additional patient follow-up required.

Integra LifeSciences identified production and process control issues for certain CVS Wound Gel products. If the affected product is used, it may lead to infection. Users may not be able to use the device due to packaging failures.

As of December 19, 2025, Integra LifeSciences has reported 11 serious injuries related to MediHoney Wound and Burn products, three serious injuries related to CVS Wound Gel products, and no deaths associated with this issue.

Device Use

MediHoney Wound and Burn products and CVS Wound Gel products are used for the treatment of burns and wounds. These products help maintain a moist wound environment, protect skin from breakdown and irritation, or protect the skin from damage.

Contact Information

Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Integra at 1-800-654-2873 or custsvcnj@integralife.com.

Unique Device Identifier (UDI)  

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.  

How do I report a problem?  

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.