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fda_recall · device_recall · critical

Baxter Healthcare Corporation — Class I recall: Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2

Event date
2025-07-23 00:00:00Z
Observed
2026-07-16 23:20:09Z
Source ID
Z-2096-2025
Payload hash
b9b13cc8956ad0ffa4cad4f3

Summary

Certain Spectrum infusion pumps may have an incorrect version of software. Status: Ongoing.

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 2025-07-23; 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 (2025). Baxter Healthcare Corporation — Class I recall: Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-baxter-healthcare-corporation-z-2096-2025
MLA
"Baxter Healthcare Corporation — Class I recall: Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2." Argus HQ Research, Digital Empire Holdings LLC, 2025, argushq.ai/events/fda-recall-baxter-healthcare-corporation-z-2096-2025.
Chicago
Argus HQ Research. "Baxter Healthcare Corporation — Class I recall: Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2." Digital Empire Holdings LLC. Accessed July 23, 2026. https://argushq.ai/events/fda-recall-baxter-healthcare-corporation-z-2096-2025.
BibTeX
@misc{argushq_argushq_ai_events_fda_recall_baxter_healthcare_corporation_z_2096_2025_2025,
  title = {Baxter Healthcare Corporation — Class I recall: Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-baxter-healthcare-corporation-z-2096-2025},
  note = {Accessed: July 23, 2026}
}

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