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CVS Wound Care Device Recalled Due to Sterile Barrier Breach

CVS recalled 2,906 units of its wound care device on January 16, 2026. The recall stems from potential packaging failures that may compromise sterility. Affected products include model number CVS405406, distributed across multiple states and internationally.

Official notice
Integra LifeSciences Corp.Health & Personal CareMedical DevicesModel Number: CVS405406UDI-DI: 00050428452547Lot Numbers: 2428

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
January 16, 2026
Status
ACTIVE
Severity
8/10

Quick Facts at a Glance

Recall Date
January 16, 2026
Hazard Level
HIGH
Brand
Integra LifeSciences Corp.
Category
Health & Personal Care
Sold At
CVS
Geographic Scope
1 states
At-Risk Groups
GENERAL

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
Integra LifeSciences Corp.
Product type
Wound Care Device
Model numbers
Model Number: CVS405406, UDI-DI: 00050428452547, Lot Numbers: 2428, 2446, 2509, 2514.
Sold at
CVS
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    January 16, 2026

  2. Reported by FDA DEVICE

    February 25, 2026

  3. RecallRadar source check

    March 4, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

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

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Integra LifeSciences Corp. (NeuroSciences) or your healthcare provider for instructions. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

About This Product

The CVS405406 wound care device helps maintain a moist environment for healing minor wounds. Consumers typically use it for minor cuts, burns, and abrasions.

Why This Is Dangerous

The potential packaging failures can compromise the device's sterility, leading to an increased risk of infection for users. This is particularly concerning for individuals with open wounds.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Consumers must stop using the product immediately to avoid health risks. This recall may cause inconvenience for those relying on the device for wound care.

Practical Guidance

How to identify if yours is affected

  1. Check the product model number to confirm it is CVS405406.
  2. Look for the specified lot numbers: 2428, 2446, 2509, 2514.
  3. Verify the packaging for signs of damage or failure.

Where to find product info

The model number and lot numbers can typically be found on the packaging or the product label.

What timeline to expect

Expect a timeline of 4-6 weeks for refund processing after returning the device.

If the manufacturer is unresponsive

  • Document all correspondence with the manufacturer.
  • Follow up via phone if you do not receive a response within a reasonable timeframe.
  • Consider filing a complaint with the CPSC if there is no action taken.

How to prevent similar issues

  • Always check for recalls on medical devices before purchasing.
  • Look for devices with clear packaging integrity indicators.
  • Opt for products with strong manufacturer reputations and safety records.

Documentation advice

Keep copies of receipts, correspondence, and any documentation related to the recall as evidence for your records.

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Product Details

The recalled product is the CVS405406 wound care device, designed to maintain a moist wound environment. It was sold nationwide in the U.S. and in various countries, including Canada and the UK. The device was distributed at a price not specified.

Key Facts

  • Recalled model: CVS405406
  • Potential breach in sterile barrier
  • Stop use immediately
  • Contact manufacturer for instructions

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Model Numbers
Model Number: CVS405406
UDI-DI: 00050428452547
Lot Numbers: 2428
2446
2509
+1 more
Affected States
ALL
Report Date
February 25, 2026
Recall Status
ACTIVE

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