FDA Enforcement
Class II
Ongoing
Cytal Burn Matrix 7x10 cm. Product ID: BMM0710.
Recall: Z-1819-2026
·
Reported April 22, 2026
Enforcement
- Recall Number
- Z-1819-2026
- Event ID
- 98607
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Integra LifeSciences Corp. (NeuroSciences)
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 22, 2026
- Initiation Date
- March 19, 2026
- Classification Date
- April 15, 2026
- Address
- 1100 Campus Rd, N/A, Princeton, NJ, 08540-6650, United States
Description
Cytal Burn Matrix 7x10 cm. Product ID: BMM0710.
Reason
Increased rate of out-of-specification endotoxin results.
Code Info
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.
Quantity
7 units