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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/Surgical Equipment

Cytal Wound and Burn Matrix Recalled for High Endotoxin Levels

Agency Publication Date: April 15, 2026
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Summary

Integra LifeSciences is recalling approximately 879 units of Cytal Wound and Burn Matrix products because they may contain high levels of endotoxins. These medical devices are used by healthcare professionals for wound and burn care. No injuries have been reported, but the company initiated this voluntary recall after discovering that certain batches did not meet endotoxin specifications during testing. Consumers and healthcare providers should identify if they have any of the affected products, which were distributed nationwide between March and April 2026.

Risk

High endotoxin levels in medical devices used on open wounds or burns can cause a severe inflammatory response, fever, or localized infection. This poses a significant health risk to patients undergoing wound treatment.

What You Should Do

  1. Identify if you have the affected Cytal Wound or Burn Matrix products by checking the Product ID, UDI-DI, and Lot Numbers on the device packaging. See the Affected Products section below for the full list of affected codes.
  2. Stop using the recalled product immediately.
  3. Contact Integra LifeSciences or your medical distributor to arrange for the return, replacement, or correction of any unused inventory.
  4. If you have health concerns or believe you have experienced a reaction to this product, contact your healthcare provider immediately.
  5. For additional questions or to report a problem, call the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Cytal Wound Matrix 2-Layer 5x5 cm
Model / REF:
WSM0505
Lot Numbers:
7579683
7583933
7583891
7583935
7594266
7594286
7593011
UDI:
00386190001431

Distributed quantity: 148 units

Product: Cytal Wound Matrix 2-Layer 7x10 cm
Model / REF:
WSM0710
Lot Numbers:
7579683
7582225
7583893
7582227
7583933
7583891
7591942
7591944
7583935
7594266
7594288
7594286
7593011
7594284
7593013
UDI:
00386190001448

Distributed quantity: 46 units

Product: Cytal Wound Matrix 2-Layer 10x15 cm
Model / REF:
WSM1015
Lot Numbers:
7579681
7582225
7583893
7582227
7591942
7591944
7583935
7594266
7593018
7594288
7594284
7593013
UDI:
00386190001455

Distributed quantity: 452 units

Product: Cytal Burn Matrix 7x10 cm
Model / REF:
BMM0710
Lot Numbers:
7579683
7579681
7582227
7583891
7594266
7593018
7593011
7593013
UDI:
00386190001103

Distributed quantity: 7 units

Product: Cytal Burn Matrix 10x15 cm
Model / REF:
BMM1015
Lot Numbers:
7579681
7582225
7582227
7583933
7591942
7591944
7583935
7593018
7594284
7593013
UDI:
00386190001110

Distributed quantity: 226 units

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98607
Status: Active
Manufacturer: Integra LifeSciences Corp. (NeuroSciences)
Sold By: Authorized Medical Distributors; Hospitals; Wound Care Centers
Manufactured In: United States
Units Affected: 879
Distributed To: Alabama, Arizona, California, District of Columbia, Florida, Georgia, Iowa, Illinois, Kansas, Kentucky, Louisiana, Maryland, Maine, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New York, Ohio, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin, West Virginia

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.

Find an Attorney

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.