FDA Medical devices recall ·
Private Label CVS. Model Number: CVS405406… recall
- Recall number
- Z-1365-2026
- Date
- (initiated January 16, 2026)
- Company / brand
- Integra LifeSciences Corp. (NeuroSciences)
1100 Campus Rd, Princeton, NJ, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 2,906 units
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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.
Why was it recalled?
Potential packaging failures, which could lead to a breach in the sterile barrier.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model Number: CVS405406; UDI-DI: 00050428452547; Lot Numbers: 2428, 2446, 2509, 2514.
Distribution
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.).
States: California Florida Indiana Michigan Missouri New Jersey New York Pennsylvania Rhode Island South Carolina Tennessee Texas Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1365-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.