FDA-Device2026-04-22Class IIPROCESSING DEFECT
Integra Cytal Wound Matrix 2-Layer recalled for high endotoxin levels
What this means
Integra LifeSciences' Cytal Wound Matrix 2-Layer 5x5 cm wound dressing (Product ID: WSM0505) has been recalled because some units have higher-than-safe levels of endotoxin, a bacterial substance that can trigger immune reactions. The affected product was distributed nationwide, and no injuries have been reported so far.
- Check if you have the affected product: Product ID WSM0505 in lot numbers 7579683, 7583933, 7583891, 7583935, 7594266, 7594286, or 7593011.
- Stop using the product immediately.
- Contact your healthcare provider or Integra LifeSciences for guidance on safe disposal and next steps.
- Do not use on wounds until you confirm your product is not affected.
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
148 units
Manufactured in
1100 Campus Rd, N/A, Princeton, NJ, United States
Products
Cytal Wound Matrix 2-Layer 5x5 cm. Product ID: WSM0505.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1816-2026Want us to check the next one for you?
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