CLASS II ONGOING Device recall · Reported 25 Feb 2026 · FDA Enforcement Report
Private Label CVS recalled by Integra LifeSciences Corp.
Integra LifeSciences Corp. (NeuroSciences) is recalling Private Label CVS, distributed nationwide in the US. The recall was initiated on 16 Jan 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1365-2026
- FDA event ID
- 98175
- Recalling firm
- Integra LifeSciences Corp. (NeuroSciences), Princeton, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 16 Jan 2026
- FDA classified
- 13 Feb 2026
- Reported
- 25 Feb 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Lead & Heavy Metals
- Device type
- Other Medical Devices
Timeline
| 16 Jan 2026 | Recall initiated by company | |
| 13 Feb 2026 | Classified by FDA | +28 days |
| 25 Feb 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential packaging failures, which could lead to a breach in the sterile barrier.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
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.
Where it was distributed
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.).
Nationwide CaliforniaFloridaIndianaMichiganMissouriNew JerseyNew YorkPennsylvaniaRhode IslandSouth CarolinaTennesseeTexasVirginia
Stores named: CVS
Questions about this recall
Is Private Label CVS recalled?
Yes. Integra LifeSciences Corp. (NeuroSciences) recalled Private Label CVS on 16 Jan 2026. The recall is Class II and its status is Ongoing. Recall number Z-1365-2026.
Why was it recalled?
Potential packaging failures, which could lead to a breach in the sterile barrier.
Which lots are affected?
Model Number: CVS405406; UDI-DI: 00050428452547; Lot Numbers: 2428, 2446, 2509, 2514.
Where was it sold?
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.).
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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