Integra Cytal Burn Matrix recalled for elevated endotoxin levels
Integra LifeSciences has recalled specific lots of Cytal Burn Matrix (a burn wound dressing) because testing found higher-than-acceptable levels of endotoxin, a bacterial substance that can trigger an immune response. Seven units were distributed across the U.S. No injuries have been reported.
From the FDA notice · Read the official notice ↗ · All Integra LifeSciences recalls
What to do
- Check if your facility has Cytal Burn Matrix product ID BMM0710 with one of these lot numbers: 7579683, 7579681, 7582227, 7583891, 7594266, 7593018, 7593011, or 7593013.
- Do not use the recalled product.
- Contact Integra LifeSciences or your supplier for instructions on returning or disposing of affected units.
- Report any adverse events to the FDA MedWatch program.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Cytal Burn Matrix 7x10 cm. Product ID: BMM0710.
- Sold in
- Nationwide
- Made for
- All ages (under 100 years)
This recall covers 5 products — see all of them.
Details
- Units affected
- 7 units
- Illnesses reported
- None reported
- Manufactured in
- 1100 Campus Rd, N/A, Princeton, NJ, United States
- Classification
- Class II
- Recall number
- Z-1819-2026
In the FDA's words
- Description
- Cytal Burn Matrix 7x10 cm. Product ID: BMM0710. Increased rate of out-of-specification endotoxin results. Product ID: BMM0710. UDI-DI: 00386190001103. Lot Numbers: 7579683, 7579681, 7582227, 7583891, 7594266, 7593018, 7593011, 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: 7 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. (this page)Z-1819-2026 · 7 units
- Cytal Burn Matrix 10x15 cm. Product ID: BMM1015.Z-1820-2026 · 226 units