Integra Cytal Burn Matrix recalled for elevated endotoxin levels
Integra LifeSciences' Cytal Burn Matrix 10x15 cm (Product ID: BMM1015) has been recalled because certain lots tested at higher-than-acceptable endotoxin levels. Endotoxins are bacterial substances that can trigger inflammatory reactions when in contact with body tissues. The FDA identified this issue across 226 units distributed nationwide.
From the FDA notice · Read the official notice ↗ · All Integra LifeSciences recalls
What to do
- Check if you have an affected lot number: 7579681, 7582225, 7582227, 7583933, 7591942, 7591944, 7583935, 7593018, 7594284, or 7593013
- Stop using the product immediately if you have an affected lot
- Contact your supplier or Integra LifeSciences for instructions on return or replacement
- Report any adverse reactions to the FDA MedWatch program
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Cytal Burn Matrix 10x15 cm. Product ID: BMM1015.
- Sold in
- Nationwide
- Made for
- All ages (under 100 years)
This recall covers 5 products — see all of them.
Details
- Units affected
- 226 units
- Illnesses reported
- None reported
- Manufactured in
- 1100 Campus Rd, N/A, Princeton, NJ, United States
- Classification
- Class II
- Recall number
- Z-1820-2026
In the FDA's words
- Description
- Cytal Burn Matrix 10x15 cm. Product ID: BMM1015. Increased rate of out-of-specification endotoxin results. Product ID: BMM1015. UDI-DI: 00386190001110. Lot Numbers: 7579681, 7582225, 7582227, 7583933, 7591942, 7591944, 7583935, 7593018, 7594284, 7593013. Distribution: 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 quantity: 226 units
- Hazard
- Increased rate of out-of-specification endotoxin results.
5 products in this recall
Integra Cytal wound and burn matrices recalled for endotoxin results
Integra LifeSciences is recalling five sizes of Cytal Wound Matrix and Cytal Burn Matrix products because an increased rate of endotoxin test results fell outside acceptable limits. The recall covers 879 units distributed across many US states. No injuries have been reported.
The agency lists each product separately. Check every one you might have.
- Cytal Wound Matrix 2-Layer 5x5 cm. Product ID: WSM0505.Z-1816-2026 · 148 units
- Cytal Wound Matrix 2-Layer 7x10 cm. Product ID: WSM0710.Z-1817-2026 · 46 units
- Cytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015.Z-1818-2026 · 452 units
- Cytal Burn Matrix 7x10 cm. Product ID: BMM0710.Z-1819-2026 · 7 units
- Cytal Burn Matrix 10x15 cm. Product ID: BMM1015. (this page)Z-1820-2026 · 226 units