Class II U.S. Food and Drug Administration

Integra LifeSciences Corp. Private Label CVS recall: Potential packaging failures, which could lead to a breach in the sterile

Recall published 8 months ago

Potential packaging failures, which could lead to a breach in the sterile barrier.

The hazard: Fire or burn hazard

The hazard here is thermal: the product can get hot enough to ignite what is around it, or to burn whoever is holding it.

What the notice says: Potential packaging failures, which could lead to a breach in the sterile barrier.

Why it matters: The product can overheat, ignite or cause a burn. Where lithium batteries are involved the failure is fast and very hot, and water does not put it out quickly.

Symptoms and when to call a doctor

Treat a burn by cooling it under running water for about 20 minutes — not with ice, butter or ointment — and cover it loosely with a clean non-fluffy cloth. Get medical help for burns that are larger than the person’s palm, that are deep or white or charred, that involve the face, hands, feet or genitals, or any burn to a baby or young child. If someone has inhaled smoke and is coughing, hoarse or short of breath, call 911.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
Z-1365-2026
Published
February 25, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Integra LifeSciences Corp.
Product type
Medical devices
Units affected
2,906 units
Distribution
Nationwide
Sold at
CVS
Made in
United States
Lot / code info
Model Number: CVS405406; UDI-DI: 00050428452547; Lot Numbers: 2428, 2446, 2509, 2514.
UPC codes
00050428452547

Products covered by this recall

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.

Check your product

The notice names 7 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00050428452547

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 2428
  • 2446
  • 2509
  • 2514. — 2
  • 906 units

Model or item number

On the rating label, the box or the instruction sheet.

  • CVS405406

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Fire

Integra LifeSciences Corp. — The hazard here is thermal: the product can get hot enough to ignite what is around it, or to burn whoever is holding it.

  1. Stop using it and unplug it from the wall. If it runs on a battery pack, stop charging it.
  2. Check that your smoke alarms work while you are thinking about it, and follow the remedy on this page.
  3. Move it off anything that burns — a bed, a sofa, a carpet, a pile of paper — and away from exits.
  4. Do not leave it charging overnight or while the house is empty while you wait for the remedy.

If the claim stalls

Most recall claims are paid without argument. The ones that stall usually stall for a reason you can fix.

  • Check you used the recall channel rather than ordinary customer support — the two queues rarely talk to each other.
  • If the company is unresponsive or has stopped trading, report it to the CPSC at SaferProducts.gov, and try the retailer in parallel.
  • Paid by card? A chargeback for goods that are unfit for sale is a legitimate fallback once the company has had a fair chance.
  • Send the photos they asked for in the format they asked for. A missing date code is the single commonest reason a claim sits unprocessed.

Company contact: Integra LifeSciences Corp. (NeuroSciences) — 1100 Campus Rd, Princeton, NJ, 08540-6650

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Integra LifeSciences Corp. medical devices recalled?

Potential packaging failures, which could lead to a breach in the sterile barrier. Potential packaging failures, which could lead to a breach in the sterile barrier.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00050428452547; lot code 2428, 2446, 2509; model number CVS405406. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Stop using it and unplug it from the wall. If it runs on a battery pack, stop charging it.

Can I get my money back?

Check you used the recall channel rather than ordinary customer support — the two queues rarely talk to each other.

Where was the recalled product sold?

It was distributed nationwide, including at CVS.

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