Syringes with Low Dead Space labeled as: a) SOL-M 1ml Slip Tip… — Class II medical device recall Z-3078-2024
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-3078-2024 |
|---|---|
| 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 | 00810018097554, 00810062435319, 00818392018165, 00840368511899 |
| Lot numbers | 1102070, 1107062, 19052401, 2002005, 2006004, 2012008, 2909022, 2911053, 4104025, 4104027, 4104028, 4104029, 4104030, 4104031, 4104032, 4104100, 4105038, 4106031, 4106032, 4106033, 4106074, 4106075, 4106079, 4106080, 4106081, 4106082, 4106083, 4106086, 4108014, 4108015, 4108017, 4108095, 4109088, 4110059, 4110091, 4110092, 4202001, 4212021, 4301003, 4301029 and 29 more |
| Model numbers | 12558LDS, 180011LDS, 181023L, 181025S, P180001PP, P180011LDS |
Product
Syringes with Low Dead Space labeled as: a) SOL-M 1ml Slip Tip Syringe w/o needle (low dead space), Model No. 180011LDS, UPC 840368511899; b) SOL-M 1ml Slip Tip Syringe w/o needle (low dead space), Model No. P180011LDS, UPC 810018097554; c) SOL-M 1ml Luer Lock Syringe w/Exch Needle 23G*1" (low dead space), Model No. 181023L, UPC Sold in Canada Only; d) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 25G*5/8" low dead space), Model No. 12558LDS, UPC 810062435319; e) SOL-M 1ml Luer Lock Syringe w/o Needle (PP) (low dead space), Model No. P180001PP, UPC 818392018165; f) SOL-M 1ml TB Slip Tip Syringe w/Exch Needle 25G*5/8'' (low dead space), Model No. 181025S, UPC Sold in Canada Only
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-3078-2024. 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.