Syringes with Fixed Needles labeled as: a) SOL-M: 1) SOL-M 1ml TB… — Class II medical device recall Z-3074-2024
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-3074-2024 |
|---|---|
| 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 | 00810018098148, 00810018098155, 00810018098162, 00810018098827, 00818392011593, 00818392011609, 00818392011616, 00818392014884, 10192253025149, 10192253025156, 10192253025163, 10192253025170, 10192253025187, 10192253025194, 10192253025200, 10192253025217, 10192253025224, 10192253025231, 10192253025248, 10304040017057, 10304040017064, 10304040017071, 10304040017088, 10304040017095, 10304040017101 and 21 more |
| Lot numbers | 1001003, 1001008, 1001014, 1001016, 1001017, 1001019, 1001020, 1001021, 1003005, 1003006, 1003007, 1003008, 1003009, 1003010, 1004001, 1004002, 1004039, 1004040, 1004041, 1006001, 1006002, 1006016, 1006027, 1007001, 1007002, 1007004, 1007005, 1007006, 1007007, 1008006, 1008007, 1008008, 1008011, 1008012, 1008020, 1008021, 1008022, 1008023, 1008024, 1009001 and 360 more |
| Model numbers | 11812558, 11812705, 11813005, 11832010, 11832015, 11832110, 11832115, 11832210, 11832215, 11832310, 11832315, 11832510, 11832558, 12310SN, 12315SN, 12515SN, 181025, 1811815B, 1831815B, 1851815B, 32515SN, 900-7640, 900-7641, 900-7642, 900-7643 and 23 more |
Product
Syringes with Fixed Needles labeled as: a) SOL-M: 1) SOL-M 1ml TB Syringe w/Fixed Needle 25G*5/8'', Model No. 181025, UPC 818392014884; 2) SOL-M 3ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2'', Model No. 1831815B, UPC 818392011593; 3) SOL-M 5ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2'', Model No. 1851815B, UPC 818392011609; 4) SOL-M 10ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2'', Model No. 1811815B, UPC 818392011616;
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-3074-2024. 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.