Medical Device Recall: SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2
Baxter Healthcare Corporation · November 28, 2025
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.
Distribution
US Nationwide distribution.
States Affected
NATIONWIDE
Quantity Affected
585 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1121-2026
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.