FDA-Device2026-02-25Class IIPACKAGING DEFECT
CVS Private Label wound care gel recalled for potential sterile barrier failure
What this means
CVS Private Label wound care gel (model CVS405406) may have packaging defects that could compromise the sterile barrier protecting the product. This affects specific lot numbers and could allow contamination of the gel used for minor burns, cuts, and abrasions.
- Check if you have model CVS405406 with lot numbers 2428, 2446, 2509, or 2514
- Do not use the product if you have an affected lot
- Contact CVS or Integra LifeSciences for instructions on return or disposal
- Use an alternative wound care product for minor cuts and burns
The agency's original wording
Hazard
Potential packaging failures, which could lead to a breach in the sterile barrier.
Intended for
All ages
Illnesses reported
None reported
Sold states
Worldwide - US Nationwide distribution in the states of TX, MI, FL, IN, MO, CA, VA, NJ, PA, SC, TN, RI, NY and the countries of Australia, Austria, Bahrain, Canada, Finland, France, Germany, Greece, Guam, Guernsey, Hungary, Iran (Islamic Republic of), Iraq, Ireland, Israel, Italy, Korea (the Republic of), Kuwait, Lebanon, Madagascar, Malaysia, Netherlands (the), New Zealand, Norway, Poland, Portugal, Romania, Saudi Arabia, Serbia, Slovenia, Spain, Switzerland, Tunisia, Uganda, United Arab Emirates (the), United Kingdom of Great Britain and Northern Ireland (the), Virgin Islands (U.S.).
Affected count
2,906 units
Manufactured in
1100 Campus Rd, Princeton, NJ, United States
Products
Private Label CVS. Model Number: CVS405406. Helps maintain a moist wound environment, which has shown to be conducive to wound healing. Intended for minor scalds & burns, minor cuts, lacerations & minor abrasions.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1365-2026Want us to check the next one for you?
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