FDA-Device2026-04-22Class IIPROCESSING DEFECT
Integra Cytal Burn Matrix recalled for elevated endotoxin levels
OTHERNationwide distribution
Stop using Cytal Burn Matrix 7x10 cm
Integra LifeSciences has recalled specific lots of Cytal Burn Matrix (a burn wound dressing) because testing found higher-than-acceptable levels of endotoxin, a bacterial substance that can trigger an immune response. Seven units were distributed across the U.S. No injuries have been reported.
- Check if your facility has Cytal Burn Matrix product ID BMM0710 with one of these lot numbers: 7579683, 7579681, 7582227, 7583891, 7594266, 7593018, 7593011, or 7593013.
- Do not use the recalled product.
- Contact Integra LifeSciences or your supplier for instructions on returning or disposing of affected units.
- Report any adverse events 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
7 units
Manufactured in
1100 Campus Rd, N/A, Princeton, NJ, United States
Products
Cytal Burn Matrix 7x10 cm. Product ID: BMM0710.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1819-2026More Integra LifeSciences Corp. (NeuroSciences) recalls
- FDA-Device2026-05-20Integra Codman CerebroFlo EVD Catheter recalled for elevated endotoxin levels
- FDA-Device2026-04-22Integra Cytal Burn Matrix recalled for elevated endotoxin levels
- FDA-Device2026-04-22Integra Cytal Wound Matrix 2-Layer recalled for high 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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