Integra LifeSciences Recalls Private Label CVS Wound Care Products Over Sterility Concerns

What Happened

Integra LifeSciences Corp. (NeuroSciences) has initiated a voluntary recall of private label CVS wound care products. The recall was triggered by potential packaging failures that could lead to a breach in the sterile barrier of the device. Such a breach may compromise the product’s sterility, potentially exposing users to contaminants during wound treatment.

Which Products Are Affected

The recall affects 2,906 units of the following product:

• Brand/Product: Private Label CVS Wound Care
• Model Number: CVS405406
• UDI-DI: 00050428452547
• Lot Numbers: 2428, 2446, 2509, 2514

These products are intended for use on minor scalds, burns, cuts, lacerations, and abrasions to help maintain a moist wound environment conducive to healing.

Distribution was worldwide, including U.S. nationwide distribution in the states of TX, MI, FL, IN, MO, CA, VA, NJ, PA, SC, TN, RI, and NY. International distribution included Australia, Austria, Bahrain, Canada, Finland, France, Germany, Greece, Guam, Guernsey, Hungary, Iran, Iraq, Ireland, Israel, Italy, Korea, Kuwait, Lebanon, Madagascar, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Saudi Arabia, Serbia, Slovenia, Spain, Switzerland, Tunisia, Uganda, United Arab Emirates, United Kingdom, and the U.S. Virgin Islands.

What You Should Do

Consumers and healthcare providers should immediately check their inventory for the affected model and lot numbers. Integra LifeSciences has initiated notification to customers through multiple channels, including email, fax, letters, telephone, and press releases. If you possess the affected products, you should follow the instructions provided by the manufacturer regarding the return or disposal of the items.

Why This Matters

A breach in the sterile barrier of a wound care product increases the risk of infection for patients treating open wounds, cuts, or burns. Maintaining sterility is critical for products designed to facilitate safe wound healing.

Source

FDA Recall Notice Z-1365-2026 - Information provided by the Food and Drug Administration.