Z-1816-2026 Class II Ongoing
FDA device recall Z-1816-2026 was initiated by Integra LifeSciences Corp. (NeuroSciences) on March 19, 2026 and is designated Class II. Reason for recall: Increased rate of out-of-specification endotoxin results. The recall status is ongoing. Affected quantity: 148 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 22, 2026
- Initiation Date
- March 19, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 148 units
Product Description
Cytal Wound Matrix 2-Layer 5x5 cm. Product ID: WSM0505.
Reason for Recall
Increased rate of out-of-specification endotoxin results.
Distribution Pattern
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.
Code Information
Product ID: WSM0505. UDI-DI: 00386190001431. Lot Numbers: 7579683, 7583933, 7583891, 7583935, 7594266, 7594286, 7593011.