Baxter Sigma Spectrum Infusion Pump Recall for Bearing Failure Risk
Baxter Healthcare is recalling 63,225 Sigma Spectrum Infusion Pumps because bearing lubricant loss can cause flow failures and potential over-infusion.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a Class 2 medical device with a risk of over-infusion (a risk-of-harm product) where no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria.
Plain-English summary
Baxter Healthcare Corporation is recalling 63,225 Sigma Spectrum Volumetric Infusion Pumps (Part Number 35700) due to a risk of bearing failure. The pumps are intended for the controlled administration of intravenous fluids, including blood, blood products, or pharmaceutical drugs.
The recall is an expansion of a previous action. Sigma's evaluation of complaints indicated that the loss or degradation of bearing lubricant is a significant contributor to bearing failure. This failure can cause inaccurate flow conditions, ranging from back flow to free flow, which could result in over-infusion. The recall includes units manufactured between January 18, 2005, and November 1, 2010, with serial numbers ranging from 700000 through 794213.
The affected units were distributed worldwide, including the United States (nationwide including Puerto Rico), Canada, and Okinawa. Healthcare facilities should check their inventory for these serial numbers and contact Baxter Healthcare for instructions on how to proceed with the recall.
The recalled product
- Product
- Sigma Spectrum VOLUMETRIC INFUSION PUMP, with or without Master Drug Library, Part Number 35700 -- Common/Classification Name: Infusion Pump -- Class 2 medical device -- SIGMA LLC, Medina, NY 14103 Product Usage: The Spectrum Infusion Pump is intended to be used for the cont
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — Infusion Pump
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Serial numbers ranging from 700000 through 794213: 700000
- 700001
- 700002
- 700003
- 700004
- 700005
- 700006
- 700007
- 700010
- 700012
- 700013
- 700014
- 700017
- 700018
- 700020
- 700021
- 700022
- 700023
- 700024
- 700029
Distribution
Related recalls
Same manufacturer · Baxter Healthcare Corporation
See all →- HighBaxter Duo-Vent Solution Set Recalled for Air Bubbles in Tubing
FDA (Devices) · 2026-08-19
- SevereBaxter Recalls Cefazolin Injection Bags Due to Particulate Matter
FDA (Drugs) · 2026-08-19
- SevereHillrom VOLARA System P.CIRCUIT KIT Medical Device Recall for Oxygen Drop Risk
FDA (Devices) · 2026-07-08
- HighBaxter Head Positioning Adapter May Loosen During Patient Positioning
FDA (Devices) · 2026-07-08
- SevereHillrom VOLARA System patient circuits recalled for nebulizer leakage risk
FDA (Devices) · 2026-07-08
Same hazard · over infusion
See all →- HighSIGMA Spectrum infusion pumps recalled over defective grease on the gears
FDA (Devices) · 2026-01-28
- CriticalInfusion pump modules recalled because drops can damage the bezel assembly
FDA (Devices) · 2025-11-26
- HighInfusion pumps recalled because degrading grease may cause excessive therapy delivery
FDA (Devices) · 2025-09-03
- HighInfusion Pump Manual Instructs Users to Leave Safety Clamp Open
FDA (Devices) · 2025-03-05
- HighIvenix Infusion System Software Defect May Delay or Cause Incorrect Infusions
FDA (Devices) · 2024-03-20