Official recall record
SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2025-11-28
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 00085412498683
- Brand on record
- Baxter Healthcare Corporation
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Record last checked against the registry on 2026-05-31.
Same barcode in other registries
The same EAN appears in 6 other official recall record(s) — a cross-border signal worth checking if you bought this product abroad.
- 2020-06-30 · US FDA — Medical Devices
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) - 2020-11-23 · US FDA — Medical Devices
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) - Product Usage: intended to be used for the co - 2024-11-19 · US FDA — Medical Devices
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product Code 35700BAX2 - 2024-07-17 · US FDA — Medical Devices
Spectrum Wireless Battery Modules A/B/G/N, product code 36010, used with either of the following 35700BAX2 (Spectrum V8 - 2024-07-17 · US FDA — Medical Devices
Baxter Spectrum Wireless Battery Modules A/B/G/N, product code 35223, used with either of the following: 35700BAX2 (Spe
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All 43 official recall notices naming Baxter Healthcare Corporation on this site →