FDA-Device2026-04-22Class IIPROCESSING DEFECT
Integra Cytal Wound Matrix recalled for elevated endotoxin levels
OTHERNationwide distribution
Stop using Integra Cytal Wound Matrix
Integra LifeSciences' Cytal Wound Matrix 2-Layer (7x10 cm) from specific lot numbers tested higher than safe endotoxin levels. Endotoxins are bacterial substances that can trigger harmful immune responses. No injuries have been reported so far.
- Check if you have any Cytal Wound Matrix with lot numbers 7579683, 7582225, 7583893, 7582227, 7583933, 7583891, 7591942, 7591944, 7583935, 7594266, 7594288, 7594286, 7593011, 7594284, or 7593013
- Do not use affected units on patients
- Contact Integra LifeSciences immediately about product disposition and guidance
- 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
46 units
Manufactured in
1100 Campus Rd, N/A, Princeton, NJ, United States
Products
Cytal Wound Matrix 2-Layer 7x10 cm. Product ID: WSM0710.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1817-2026More 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-Device2026-04-22Cytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015.
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