FDA-Device2026-04-22Class IIPROCESSING DEFECT
Integra Cytal Wound Matrix recalled for elevated endotoxin levels
What this means
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
The agency's original wording
Hazard
Increased rate of out-of-specification endotoxin results.
Intended for
Adults
Illnesses reported
None reported
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-1817-2026Want us to check the next one for you?
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