Has Baxter Healthcare Corporation had other FDA enforcement actions?

Yes. Argus HQ has recorded 208 total FDA actions tied to Baxter Healthcare Corporation: 0 warning letters, 208 recalls, 0 approval records, and 0 Form 483 inspection citations.

What kind of FDA record is this?

This is an Argus HQ record of a FDA Recall, tagged critical severity by Argus HQ. FDA published the underlying record on 2023-07-19; Argus observed and indexed it on 2026-07-16.

Where can I verify this record directly with FDA?

The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

.hq

fda_recall · device_recall · critical

Baxter Healthcare Corporation — Class I recall: The Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 35700…

Name: FDA Recall Record — Baxter Healthcare Corporation
Creator: Argus HQ
Published: 2023-07-19
License: https://argushq.ai/methodology

Event date: 2023-07-19 00:00:00Z
Observed: 2026-07-16 23:20:10Z
Source ID: Z-2104-2023
Payload hash: 368d3d7904723ea63936efb3…

Summary

A medical device correction is being issued for SIGMA Spectrum Infusion System (V8 Platform) and Spectrum IQ Infusion System with Dose IQ Safety Software infusion pumps due to an increase in reported false upstream occlusion alarms following upgrades to software versions v8.01.01 and v9.02.01. Status: Ongoing.

Entities

Baxter Healthcare Corporation

View source record ↗

Frequently asked questions

Has Baxter Healthcare Corporation had other FDA enforcement actions?: Yes. Argus HQ has recorded 208 total FDA actions tied to Baxter Healthcare Corporation: 0 warning letters, 208 recalls, 0 approval records, and 0 Form 483 inspection citations.
What kind of FDA record is this?: This is an Argus HQ record of a FDA Recall, tagged critical severity by Argus HQ. FDA published the underlying record on 2023-07-19; Argus observed and indexed it on 2026-07-16.
Where can I verify this record directly with FDA?: The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2023). Baxter Healthcare Corporation — Class I recall: The Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 35700…. Digital Empire LLC. Retrieved from https://argushq.ai/events/fda-recall-baxter-healthcare-corporation-z-2104-2023

MLA

"Baxter Healthcare Corporation — Class I recall: The Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 35700…." Argus HQ Research, Digital Empire LLC, 2023, argushq.ai/events/fda-recall-baxter-healthcare-corporation-z-2104-2023.

Chicago

Argus HQ Research. "Baxter Healthcare Corporation — Class I recall: The Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 35700…." Digital Empire LLC. Accessed July 17, 2026. https://argushq.ai/events/fda-recall-baxter-healthcare-corporation-z-2104-2023.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_baxter_healthcare_corporation_z_2104_2023_2023,
  title = {Baxter Healthcare Corporation — Class I recall: The Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 35700…},
  author = {{Argus HQ Research}},
  year = {2023},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/events/fda-recall-baxter-healthcare-corporation-z-2104-2023},
  note = {Accessed: July 17, 2026}
}

Informational only. Not legal, financial, or medical advice.