Syringes with Eccentric Tips labeled as: 1) SOL-M 10ml Eccentric Tip… — Class II medical device recall Z-3077-2024
Ongoing recall by Sol-Millennium Medical Inc., reported 2024-09-18, distributed nationwide. Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)
| Recall number | Z-3077-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sol-Millennium Medical Inc., Chicago, IL, United States |
| Recall initiated | 2024-05-09 |
| Classified | 2024-09-06 |
| Reported by FDA | 2024-09-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BB, BE, BR, CA, CH, CL, CZ, DE, DK, ES, FR, GB, GT, IE, IT, JM, LV, MX, MY, PA, PH, PL, PT, RO, SA, SE, SG, SI, TW |
| UPC / GTIN / UDI-DI | 00810018098605, 00810018098698 |
| Lot numbers | 4209009, 4209010, 4209011 |
| Model numbers | P180010ET, P180020ET, P180060ET |
Product
Syringes with Eccentric Tips labeled as: 1) SOL-M 10ml Eccentric Tip Syringe w/o Needle, Model No. P180010ET, UPC 81001809551; 2) SOL-M 20ml Eccentric Tip Syringe w/o Needle, Model No. P180020ET, UPC 810018098605; 3) SOL-M 60ml Eccentric Tip Syringe w/o Needle, Model No. P180060ET, UPC 810018098698;
Reason for recall
Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use.
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-3077-2024. 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.