Baxter SIGMA Spectrum Infusion Pump Recalled for Potential Software Error
Baxter Healthcare is recalling SIGMA Spectrum Infusion Pumps due to a potential software error during programming.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a potential software error without reporting any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Baxter Healthcare Corporation is recalling the Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6). The recall involves 293,926 devices that were distributed worldwide, including the United States, Canada, Barbados, Jamaica, Bermuda, Guyana, Bahamas, and Trinidad and Tobago.
The recall is being conducted because of a potential software error that may occur during programming. The devices are intended to be used for the controlled administration of fluids.
The source text does not specify specific actions for consumers or healthcare providers beyond the recall notice itself.
The recalled product
- Product
- Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage: intended to be used for the controlled administration of fluids.
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — Infusion Pump
- Hazard
- Affected units
- 293,926
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 (2)
- Product Code 35700BAX
- GTIN 00085412091587
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Baxter Healthcare Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same manufacturer · Baxter Healthcare Corporation
See all →- ModerateBaxter PRO+ Mattress Recalled for UDI Labeling Error
FDA (Devices) · 2026-09-30
- ModerateBaxter Recalls Two VOLARA Systems Due to Potential Flow Rate Inaccuracy
FDA (Devices) · 2026-09-30
- ModerateBaxter Recalls PRO+ MRS Mattress Due to UDI Labeling Error
FDA (Devices) · 2026-09-30
- ModerateBaxter PRO+ 36-inch Mattress Recalled for UDI Labeling Error
FDA (Devices) · 2026-09-30
- SevereBaxter Recalls Dextrose Injection Bags Due to Stainless Steel Particulate Matter
FDA (Drugs) · 2026-09-16
Same hazard · software error
See all →- ModerateBeckman Coulter DxC 500 AU Clinical Chemistry Analyzers Recalled for Software Error
FDA (Devices) · 2026-10-14
- HighPhilips Spectral CT 7500 Software Recall for Radiation Exposure Risk
FDA (Devices) · 2026-10-07
- HighBard EnCor EnCompass Breast Biopsy System Software Recall
FDA (Devices) · 2026-10-07
- ModerateBeckman Coulter AU480 Chemistry Analyzer Software Error Recall
FDA (Devices) · 2026-10-07
- HighPhilips EPIQ Elite Ultrasound System Recalled for Software Error
FDA (Devices) · 2026-09-30
Similar recalls
- SevereBaxter SIGMA Spectrum infusion pumps recalled for medication delivery failures
FDA (Devices) · 2022-02-09
- SevereBaxter Recalls Sigma Spectrum Volumetric Infusion Pumps Due to System Errors
FDA (Devices) · 2014-04-30
- SevereBaxter SIGMA Spectrum Infusion Pump Recall for Safety Communication Update
FDA (Devices) · 2020-10-28
- HighBaxter Recalls SIGMA SPECTRUM Infusion Pumps Due to Alarm Issues
FDA (Devices) · 2013-11-20
- SevereBaxter SIGMA Spectrum Infusion Pumps Recalled for Flow Rate Testing Errors
FDA (Devices) · 2019-05-08
- HighBaxter SIGMA Spectrum Infusion Pump Recall for Pumping Mechanism Wear
FDA (Devices) · 2018-03-21