FDA recall Z-1817-2026

Integra LifeSciences Corp. (NeuroSciences) · Class II · device

Product

Cytal Wound Matrix 2-Layer 7x10 cm. Product ID: WSM0710.

Reason for recall

Increased rate of out-of-specification endotoxin results.

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.

Key facts

Status
Ongoing
Initiation date
2026-03-19
Report date
2026-04-22
Voluntary/Mandated
Voluntary: Firm initiated
Location
Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1817-2026