SIGMA Spectrum Infusion Pump — Class II medical device recall Z-1121-2026
Ongoing recall by Baxter Healthcare Corporation, reported 2026-01-28, distributed nationwide. Certain pumps have potentially been released from service with defective grease applied to the cam and motor g
| Recall number | Z-1121-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2025-11-28 |
| Classified | 2026-01-16 |
| Reported by FDA | 2026-01-28 |
| Distributed | Nationwide (US) |
| Quantity | 585 units |
| UPC / GTIN / UDI-DI | 00085412498683 |
| Serial numbers | 2000826, 2002102, 2002118, 2002778, 2002918, 2003644, 2003675, 2004185, 2004327, 2004449, 2004602, 2004798, 2005033, 2005818, 2006741, 2007553, 2007842, 2009374, 2009532, 2009588, 2009829, 2010134, 2010527, 2010593, 2011314 and 475 more |
| Model numbers | 35700BAX2 |
Product
SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2
Reason for recall
Certain pumps have potentially been released from service with defective grease applied to the cam and motor gears. Due to its low viscosity, the defective grease may lead to the device having insufficient lubrication on the cam, which could lead to premature wear of the mechanism assembly, resulting in over-infusion or a free-flow situation.
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-1121-2026. 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.