Syringes with exchangeable needles labeled as: SOL-CARE: 1) SOL-CARE… — Class II medical device recall Z-3075-2024
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-3075-2024 |
|---|---|
| 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 | 00818392010022, 00818392010039, 00818392010046, 00818392010053, 00818392010077, 00818392010084, 00818392010091, 00818392010107, 00818392010114, 00818392010169, 00818392010183, 00818392010190, 00818392010206, 00818392010237, 00818392010244, 00818392010251, 00818392010268, 00818392010275, 00818392011586, 00818392012880, 00818392013061, 00818392013696, 00818392013702, 00818392014341, 00818392014358 and 19 more |
| Lot numbers | 10033, 1010016, 1012011, 1012019, 1012089, 1012090, 1012091, 1102061, 1102062, 1103043, 1103044, 1103045, 1103046, 1103053, 1110067, 1112021, 1112056, 1301021, 19021824, 19021825, 19021826, 1902183, 19030602, 19030603, 19041740, 19041742, 19052010, 19072314, 19072315, 2108094, 2111063, 2111064, 2203033, 2209013, 2211025, 2211026, 2211027, 2303042, 2307003, 2307005 and 175 more |
| Model numbers | 102115SN, 102215SN, 110101120011, 110101120012, 12510SN, 12558SN, 12705SN, 13005SN, 1812010, 1812015, 1812110, 1812115, 1812210, 1832010, 1832015, 1832110, 1832110T, 1832115, 1832210, 1832210T, 1832215, 1832310, 1832310T, 1832510, 1832515 and 19 more |
Product
Syringes with exchangeable needles labeled as: SOL-CARE: 1) SOL-CARE 10ml Luer Lock Syringe w/Safety Needle 21G*1 1/2 (needle aside), Model No. 102115SN, UPC 818392019858; 2) SOL-CARE 10ml Luer Lock Syringe w/Safety Needle 22G*1 1/2 (needle aside), Model No. 102215SN, UPC 818392019865; 3) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 25G*1 (needle aside), Model No. 12510SN, UPC 818392018851; 4) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 25G*5/8 (needle aside), Model No. 12558SN, UPC 818392018950; 5) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 27G*1/2 (needle aside), Model No. 12705SN, UPC 818392018967; 6) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 30G*1/2 (needle aside), Model No. 13005SN, UPC 818392018974; 7) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 21G*1 (needle aside), Model No. 32110SN, UPC 818392019001; 8) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 21G*1 1/2 (needle aside), Model No. 32115SN, UPC 818392019018; 9) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 22G*1 (needle aside), Model No. 32210SN, UPC 818392019025; 10) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 22G*1 1/2 (needle aside), Model No. 32215SN, UPC 818392019032; 11) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 23G*1 (needle aside), Model No. 32310SN, UPC 818392019049; 12) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 25G*1 (needle aside), Model No. 32510SN, UPC 818392019063; 13) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 25G*5/8 (needle aside), Model
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-3075-2024. 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.