FDA recall, , Moderate risk
Cytal Wound and Burn Matrices
Cytal Wound Matrix and Cytal Burn Matrix have an increased rate of out-of-specification endotoxin results.
Summary by Recall Canary from the FDA notice
What happened
Integra LifeSciences Corp. (NeuroSciences) of Princeton, New Jersey is recalling Cytal Burn Matrix and Cytal Wound Matrix 2-Layer products because of an increased rate of out-of-specification endotoxin results. The recall began on March 19, 2026, and was added to the FDA's Enforcement Report on April 15, 2026. Products were distributed nationwide in the United States, including the District of Columbia.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
5 products
Match the UDI-DI and lot code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Cytal Burn Matrix 10x15 cm. Product ID: BMM1015.
- UDI-DI
- 00386190001110
- Lot code
- 7579681
- 7582225
- 7582227
- 7583933
- 7591942
- 7591944
- 7583935
- 7593018
- 7594284
- 7593013
Cytal Wound Matrix 2-Layer 5x5 cm. Product ID: WSM0505.
- UDI-DI
- 00386190001431
- Lot code
- 7579683
- 7583933
- 7583891
- 7583935
- 7594266
- 7594286
- 7593011
Cytal Burn Matrix 7x10 cm. Product ID: BMM0710.
- UDI-DI
- 00386190001103
- Lot code
- 7579683
- 7579681
- 7582227
- 7583891
- 7594266
- 7593018
- 7593011
- 7593013
Cytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015.
- UDI-DI
- 00386190001455
- Lot code
- 7579681
- 7582225
- 7583893
- 7582227
- 7591942
- 7591944
- 7583935
- 7594266
- 7593018
- 7594288
- 7594284
- 7593013
Cytal Wound Matrix 2-Layer 7x10 cm. Product ID: WSM0710.
- UDI-DI
- 00386190001448
- Lot code
- 7579683
- 7582225
- 7583893
- 7582227
- 7583933
- 7583891
- 7591942
- 7591944
- 7583935
- 7594266
- 7594288
- 7594286
- 7593011
- 7594284
- 7593013
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the states of 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.
- Company
- Integra LifeSciences Corp. (NeuroSciences)Princeton, New Jersey
- Hazard
- Quality testing problem
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98607
- Recall numbers
- Z-1816-2026 to Z-1820-2026
All recalls from Integra LifeSciences Corp. (NeuroSciences)
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
