Cytal Wound Matrix 2-Layer 10x15 cm — Class II medical device recall Z-1818-2026
Ongoing recall by Integra LifeSciences Corp. (NeuroSciences), reported 2026-04-22, distributed nationwide. Increased rate of out-of-specification endotoxin results.
| Recall number | Z-1818-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra LifeSciences Corp. (NeuroSciences), Princeton, NJ, United States |
| Recall initiated | 2026-03-19 |
| Classified | 2026-04-15 |
| Reported by FDA | 2026-04-22 |
| Distributed | Nationwide (US) |
| Quantity | 452 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00386190001455 |
| Lot numbers | 7579681, 7582225, 7582227, 7583893, 7583935, 7591942, 7591944, 7593013, 7593018, 7594266, 7594284, 7594288 |
Product
Cytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015.
Reason for recall
Increased rate of out-of-specification endotoxin results.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1818-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.