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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Home Healthcare

Integra LifeSciences Corp.: MEDIHONEY Wound and Burn Dressing Recalled for Sterility Concerns

Agency Publication Date: October 10, 2024
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Summary

Integra LifeSciences is recalling approximately 120,124 units of MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn Dressing with Applicator. This recall affects both the 1.5-ounce (Model 31515) and 3.5-ounce (Model 31535) tube sizes distributed between December 17, 2020, and July 22, 2024. The recall was initiated because small pinholes may be present in the applicator's pouch film, which could compromise the sterile environment of the dressing. Consumers should contact their healthcare provider or the manufacturer to discuss any concerns regarding the use of these dressings.

Risk

The presence of pinholes in the applicator pouch film allows the internal components to be exposed to air and contaminants, potentially introducing bacteria to the wound or burn. Using a non-sterile dressing on sensitive wounds or burns increases the risk of infection and delayed healing.

What You Should Do

  1. Check your MEDIHONEY Wound and Burn Dressing packaging for Model Number 31515 (1.5oz tube) or Model Number 31535 (3.5oz tube).
  2. Verify if your product is affected by checking the Unique Device Identifier (UDI-DI) number: 10381780486824 for Model 31515 or 10381780486831 for Model 31535.
  3. Look for expiration dates on the packaging between 08/01/2024 and 06/01/2028 and confirm if the product was received between December 2020 and July 2024.
  4. If you have an affected product, contact your healthcare provider or Integra LifeSciences Corp. at 1-800-650-2673 for further instructions and information regarding a potential refund.
  5. Contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls if you have additional questions or need to report an incident.

Your Remedy Options

๐Ÿ“‹Other Action

Healthcare provider or manufacturer consultation

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn Dressing W/APPLICATOR (1.5oz tube)
Model / REF:
31515
10381780486824
Lot Numbers:
All lots distributed from 12/17/2020 to 07/22/2024
Date Ranges: 08/01/2024 to 06/01/2028 (Expiration Dates)
Product: MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn Dressing W/APPLICATOR (3.5oz tube)
Model / REF:
31535
10381780486831
Lot Numbers:
All lots distributed from 12/17/2020 to 07/22/2024
Date Ranges: 08/01/2024 to 06/01/2028 (Expiration Dates)

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95397
Status: Active
Manufacturer: Integra LifeSciences Corp.
Sold By: authorized medical distributors; healthcare facilities
Manufactured In: United States
Units Affected: 120124 units
Distributed To: Minnesota, Illinois, Utah, Florida, North Carolina, California, Missouri, Indiana, Mississippi, Ohio, Pennsylvania, Texas, Hawaii, Massachusetts, Washington, Georgia, Arizona, Virginia, New York, Colorado, Michigan, Oklahoma, Nevada, New Jersey, South Carolina, Oregon, Vermont, District of Columbia, Wisconsin, Tennessee, West Virginia, Kansas, Alabama, Nebraska, Maryland, Idaho, Louisiana, Arkansas, Kentucky, Iowa, Alaska, New Mexico, Maine, Rhode Island

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.