Smiths Medical Medfusion Model 4000 Syringe pump — Class II medical device recall Z-1541-2024
Ongoing recall by Smiths Medical ASD Inc., reported 2024-04-24. Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part Number G6000
| Recall number | Z-1541-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smiths Medical ASD Inc., Minneapolis, MN, United States |
| Recall initiated | 2023-12-19 |
| Classified | 2024-04-15 |
| Reported by FDA | 2024-04-24 |
| Quantity | 7,160 pumps |
| UPC / GTIN / UDI-DI | 10610586040054, 10610586040078, 10610586040818, 10610586043567, 10610586043574, 10610586043581, 15019517069624, 15019517070750, 15019517070996 |
| NDC | 04000-0101-50, 04000-0101-51, 04000-0105-50, 04000-0105-51, 04000-0105-78, 04000-0106-00, 04000-0106-01 |
| Serial numbers | 2002706, 2004098, 2006133, 2006382, 2007411, 2008160, 2009040, 2009070, 2009661, 2009709, 2009723, 2009734, 2009997, 2010837, 2011049, 2011262, 2012096, 2013299, 2013805, 2019150, 2019283, 2019287, 2019294, 2019299, 2019304 and 475 more |
| Model numbers | 3500, 4000 |
Product
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
Reason for recall
Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part Number G6000716), Lot Numbers P0407365, P0486670, and P0561740 may contain a molding defect that could potentially lead to slippage of the spring within the barrel clamp assembly. If this occurs, it could result in the inability of the pump to recognize a syringe or the pump may misidentify the size of the syringe loaded.
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-1541-2024. 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.