FDA-Device2026-04-22Class IIPROCESSING DEFECT
Cytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015.
OTHERNationwide distribution
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
452 units
Manufactured in
1100 Campus Rd, N/A, Princeton, NJ, United States
Products
Cytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1818-2026More 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 Burn Matrix recalled for elevated endotoxin levels
- FDA-Device2026-04-22Integra Cytal Wound Matrix recalled for elevated endotoxin levels
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