NeiMed NasoGel for DRY NOSES UDI-DI/UPC code: 00705928045309 SKU… — Class II medical device recall Z-1105-2025
Ongoing recall by Neilmed Pharmaceuticals Inc, reported 2025-02-12, distributed nationwide. Due to nasal spray stability failure for bioburden.
| Recall number | Z-1105-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Neilmed Pharmaceuticals Inc, Santa Rosa, CA, United States |
| Recall initiated | 2024-12-28 |
| Classified | 2025-02-05 |
| Reported by FDA | 2025-02-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | BH, GB, IE, MX, MY |
| Quantity | 89,312 |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 00705928045309 |
| Lot numbers | GSP30-0R-96-ENU-USL, GSP30-2R-48-ENU-USL, GSP30-ARA-INTL, GSP30-ENG-INT, GSP30-MAL-INTL, GSP30-SPA-INT, GSP30-SWE-INTL, NGS751, NGS754, NGS755, NGS756, NGS757, NGS760, NGS761, NGS762 |
Product
NeiMed NasoGel for DRY NOSES UDI-DI/UPC code: 00705928045309 SKU GSP30-2R-48-ENU-USL GSP30-0R-96-ENU-USL GSP30-ARA-INTL GSP30-SWE-INTL GSP30-ENG-INT GSP30-MAL-INTL GSP30-SPA-INT NasoGel Spray is a saline-based gel formula that can be sprayed to moisturize and lubricate dry and irritated anterior or front of nasal passages caused by dry climate and indoor heat.
Reason for recall
Due to nasal spray stability failure for bioburden.
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-1105-2025. 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.