Recall Z-1818-2026 ยท KGN Wound Dressing With Animal-Derived Material(S)
Integra LifeSciences Corp. (NeuroSciences)
Cytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015.
| Date | Apr 15, 2026 (initiated Mar 19, 2026) |
| Status | Open, Classified |
| Reason | Increased rate of out-of-specification endotoxin results. |
| Root cause | Under Investigation by firm |
| Action | Integra LifeSciences notified consignees on about 03/19/2026 via letter. Consignees were instructed to identify any affected units on hand and remove them immediately from service and quarantine them, complete and return the Acknowledgment Form and arrange for the return of affected units. Consignees were also instructed to forward to all affected personnel who utilize the product so they are aware of the recall and can identify any affected product that may remain in clinical areas. Distributors were instructed to identify any affected units on hand and remove them immediately from service |
| Quantity | 452 units |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152721 | Cytal Wound Matrix Acell, Inc., Dec 8, 2015 |