FDA recall Z-1816-2026

Product

Cytal Wound Matrix 2-Layer 5x5 cm. Product ID: WSM0505.

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-1816-2026