FDA Device recall Z-1816-2026
Cytal Wound Matrix 2-Layer 5x5 cm
- FDA Device
- Class II
- ongoing
- Published 2026-04-22
On 2026-04-22 the FDA classified a Class II recall of Cytal Wound Matrix 2-Layer 5x5 cm by Integra Lifesciences Neurosciences, citing increased rate of out-of-specification endotoxin results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1816-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-03-19 |
| Published | 2026-04-22 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Integra Lifesciences Neurosciences |
| Distribution | US |
Product
Cytal Wound Matrix 2-Layer 5x5 cm. Product ID: WSM0505.
Reason
Increased rate of out-of-specification endotoxin results.
Identifiers
| code_info | Product ID: WSM0505. UDI-DI: 00386190001431. Lot Numbers: 7579683, 7583933, 7583891, 7583935, 7594266, 7594286, 7593011. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1816-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.