FDA-Device2026-01-28Class IIPROCESSING DEFECT

Baxter SIGMA Spectrum infusion pump recalled for defective lubrication causing over-infusion risk

OTHERNationwide distribution

Stop using recalled Baxter SIGMA Spectrum pump

Baxter Healthcare has recalled certain SIGMA Spectrum infusion pumps (model 35700BAX2) because they may contain defective grease on internal gears. This defective grease does not lubricate properly, which can cause premature wear of the pump mechanism and lead to the pump delivering too much medication or allowing medication to flow freely without stopping.

  • Check if your pump's serial number matches the recall list
  • Contact Baxter Healthcare or your equipment supplier immediately if your pump is affected
  • Stop using the recalled pump and obtain a replacement or alternative pump
  • Do not attempt to repair or service the pump yourself
Hazard

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.

Sold states
US Nationwide distribution.
Affected count
585 units
Manufactured in
1 Baxter Pkwy, Deerfield, IL, United States
Products
SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1121-2026

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