FDA DevicesClass II
Cytal Wound Matrix 2-Layer 7x10 cm. Product ID: WSM0710.
Published: April 22, 2026Recall ID: Z-1817-2026Category: devicesCountry: US
Reason for Recall / Hazard
Increased rate of out-of-specification endotoxin results.
Product Description & Identification
Cytal Wound Matrix 2-Layer 7x10 cm. Product ID: WSM0710.
Additional Source Details
| Field | Value |
|---|---|
| City | Princeton |
| State | NJ |
| Event id | 98607 |
| Address 1 | 1100 Campus Rd |
| Address 2 | N/A |
| Code info | Product ID: WSM0710. UDI-DI: 00386190001448. Lot Numbers: 7579683, 7582225, 7583893, 7582227, 7583933, 7583891, 7591942, 7591944, 7583935, 7594266, 7594288, 7594286, 7593011, 7594284, 7593013. |
| Postal code | 08540-6650 |
| Report date | 20260422 |
| Product type | Devices |
| Product quantity | 46 units |
| Reason for recall | Increased rate of out-of-specification endotoxin results. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260319 |
| Initial firm notification | Letter |
| Center classification date | 20260415 |
Overview
- Recalling FirmIntegra LifeSciences Corp. (NeuroSciences)
- StatusOngoing
- Risk LevelClass II
- DistributionUS 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.