Has Baxter Healthcare Corporation had other FDA enforcement actions?

Yes. Argus HQ has recorded 235 total FDA actions tied to Baxter Healthcare Corporation: 0 warning letters, 235 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 high severity by Argus HQ. FDA published the underlying record on 2026-09-30; Argus observed and indexed it on 2026-10-06.

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 · high

Baxter Healthcare Corporation — Class II recall: Brand Name: VOLARA System Product Name: VOLARA, HC, NA A Model/Catalog Number:…

Name: FDA Recall Record — Baxter Healthcare Corporation
Creator: Argus HQ
Published: 2026-09-30
License: https://argushq.ai/methodology

Event date: 2026-09-30 00:00:00Z
Observed: 2026-10-06 04:20:28Z
Source ID: Z-3257-2026
Payload hash: dbb4133bf0d16dce0d057ede…

Summary

Contamination within the release test equipment flow path could have affected the accuracy of the nebulizer flow rate. Affected devices returned to firm and testing confirmed devices meet specifications. 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 235 total FDA actions tied to Baxter Healthcare Corporation: 0 warning letters, 235 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 high severity by Argus HQ. FDA published the underlying record on 2026-09-30; Argus observed and indexed it on 2026-10-06.
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 (2026). Baxter Healthcare Corporation — Class II recall: Brand Name: VOLARA System  Product Name: VOLARA, HC, NA A  Model/Catalog Number:…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-baxter-healthcare-corporation-z-3257-2026

MLA

"Baxter Healthcare Corporation — Class II recall: Brand Name: VOLARA System  Product Name: VOLARA, HC, NA A  Model/Catalog Number:…." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-baxter-healthcare-corporation-z-3257-2026.

Chicago

Argus HQ Research. "Baxter Healthcare Corporation — Class II recall: Brand Name: VOLARA System  Product Name: VOLARA, HC, NA A  Model/Catalog Number:…." Digital Empire Holdings LLC. Accessed October 6, 2026. https://argushq.ai/events/fda-recall-baxter-healthcare-corporation-z-3257-2026.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_baxter_healthcare_corporation_z_3257_2026_2026,
  title = {Baxter Healthcare Corporation — Class II recall: Brand Name: VOLARA System  Product Name: VOLARA, HC, NA A  Model/Catalog Number:…},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-baxter-healthcare-corporation-z-3257-2026},
  note = {Accessed: October 6, 2026}
}

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