FDA-Device2026-04-22Class IIPROCESSING DEFECT
Integra Cytal Burn Matrix recalled for elevated endotoxin levels
OTHERNationwide distribution
Stop using Integra Cytal Burn Matrix
Integra LifeSciences' Cytal Burn Matrix 10x15 cm (Product ID: BMM1015) has been recalled because certain lots tested at higher-than-acceptable endotoxin levels. Endotoxins are bacterial substances that can trigger inflammatory reactions when in contact with body tissues. The FDA identified this issue across 226 units distributed nationwide.
- Check if you have an affected lot number: 7579681, 7582225, 7582227, 7583933, 7591942, 7591944, 7583935, 7593018, 7594284, or 7593013
- Stop using the product immediately if you have an affected lot
- Contact your supplier or Integra LifeSciences for instructions on return or replacement
- Report any adverse reactions to the FDA MedWatch program
Hazard
Increased rate of out-of-specification endotoxin results.
Sold states
US Nationwide distribution in the states of AL, AZ, CA, DC, FL, GA, IA, IL, KS, KY, LA, MD, ME, MN, MO, MT, NC, ND, NE, NJ, NY, OH, PA, SC, SD, TN, TX, VA, VT, WA, WI, WV.
Affected count
226 units
Manufactured in
1100 Campus Rd, N/A, Princeton, NJ, United States
Products
Cytal Burn Matrix 10x15 cm. Product ID: BMM1015.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1820-2026More Integra LifeSciences Corp. (NeuroSciences) recalls
- FDA-Device2026-05-20Integra Codman CerebroFlo EVD Catheter recalled for elevated endotoxin levels
- FDA-Device2026-04-22Integra Cytal Wound Matrix 2-Layer recalled for high endotoxin levels
- FDA-Device2026-04-22Integra Cytal Burn Matrix recalled for elevated endotoxin levels
- FDA-Device2026-04-22Integra Cytal Wound Matrix recalled for elevated endotoxin levels
- FDA-Device2026-04-22Cytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015.
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