Private Label CVS — Class II medical device recall Z-1365-2026
Ongoing recall by Integra LifeSciences Corp. (NeuroSciences), reported 2026-02-25, distributed nationwide. Potential packaging failures, which could lead to a breach in the sterile barrier.
| Recall number | Z-1365-2026 |
|---|---|
| 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 | 2026-01-16 |
| Classified | 2026-02-13 |
| Reported by FDA | 2026-02-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BH, CA, CH, DE, ES, FI, FR, GB, GR, HU, IE, IL, IQ, IR, IT, KR, KW, LB, MY, NL, NO, NZ, PL, PT, RO, RS, SA, SI, TN |
| Quantity | 2,906 units |
| Reason classes | sterility, packaging |
| UPC / GTIN / UDI-DI | 00050428452547 |
| Lot numbers | 2428, 2446, 2509, 2514 |
| Model numbers | CVS405406 |
Product
Private Label CVS. Model Number: CVS405406. Helps maintain a moist wound environment, which has shown to be conducive to wound healing. Intended for minor scalds & burns, minor cuts, lacerations & minor abrasions.
Reason for recall
Potential packaging failures, which could lead to a breach in the sterile barrier.
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-1365-2026. 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.