FDA recall, , Moderate risk
Baxter SIGMA Spectrum Infusion Pump
The SIGMA Spectrum Infusion Pump has defective grease that may cause over-infusion or free-flow.
Summary by Recall Canary from the FDA notice
What happened
Baxter Healthcare Corporation of Deerfield, Illinois recalled the SIGMA Spectrum Infusion Pump because 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. The recall affected 585 units and was distributed nationwide in the US.
Baxter began the recall on November 28, 2025, and the FDA added it to its Enforcement Report on January 16, 2026. The FDA classified the recall on January 16, 2026, and included it in the weekly enforcement report on January 28, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the model number and UDI-DI listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
SIGMA Spectrum Infusion Pump
- Model number
- 35700BAX2
- UDI-DI
- 00085412498683
Recall details
- Company began the recall
- Sold in
US Nationwide distribution.
- Company
- Baxter Healthcare CorporationDeerfield, Illinois
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98167
- Recall number
- Z-1121-2026
- Quantity recalled
- 585 units
All recalls from Baxter Healthcare Corporation
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
