Integra LifeSciences Recalls Private Label CVS Wound Care Products Over Sterility Concerns
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Integra LifeSciences Corp. is recalling nearly 3,000 units of CVS-branded wound care products due to packaging defects that may compromise the sterile barrier.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on March 3, 2026 and geographically references Worldwide. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken — "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to — FDA Recalls — determines the regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.
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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.
Original source: FDA Official Notice ↗
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