Syringes with Luer Slip Tips labeled as: 1) SOL-M 1ml Slip Tip… — Class II medical device recall Z-3076-2024
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-3076-2024 |
|---|---|
| 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 | 00810018097462, 00810018097493, 00810018097523, 00810018097646, 00810018098636, 00810018098957, 00810062435333, 00810062435340, 00840368511998 |
| Lot numbers | 19072506, 4104054, 4105081, 4105121, 4107175, 4107176, 4108002, 4108076, 4110014, 4110015, 4110055, 4111055, 4209011, 4301004, 4302012, 4302041, 4302042, 4303048, 4303050, 4312056 |
| Model numbers | 180011, 180020ST, P180003ST, P180005ST, P180010ST, P180011, P180011T, P180020ST, P180030ST, P180060ST |
Product
Syringes with Luer Slip Tips labeled as: 1) SOL-M 1ml Slip Tip Syringe w/o Needle, Model No. 180011, UPC 8183923010138; 2) SOL-M 1ml Slip Tip Syringe w/o Needle, Model No. P180011, UPC 810018097523; 3) SOL-M 20ml Slip Tip Syringe w/o Needle, Model No. 180020ST, UPC 840368511998; 4) SOL-M 3ml Slip Tip Syringe w/o Needle, Model No. P180003ST, UPC 810018097493; 5) SOL-M 5ml Slip Tip Syringe w/o Needle, Model No. P180005ST, UPC 810018097462; 6) SOL-M 10ml Slip Tip Syringe w/o Needle, Model No. P180010ST, UPC 810018097646; 7) SOL-M 20ml Slip Tip Syringe w/o Needle, Model No. P180020ST, UPC 810018098636; 8) SOL-M 30ml Slip Tip Syringe w/o Needle, Model No. P180030ST, UPC 810062435333; 9) SOL-M 60ml Slip Tip Syringe w/o Needle, Model No. P180060ST, UPC 810062435340; 10) SOL-M 1ml Slip Tip Syringe Sterile Convenience Tray, Model No. P180011T, UPC 810018098957
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-3076-2024. 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.