Has Baxter Healthcare Corporation had other FDA enforcement actions?

Yes. Argus HQ has recorded 6 total FDA actions tied to Baxter Healthcare Corporation: 0 warning letters, 6 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 2026-07-08; Argus observed and indexed it on 2026-07-14.

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: Hillrom VOLARA System P.CIRCUIT KIT AC (Single Patient Use Circuit), Model/Catal…

Name: FDA Recall Record — Baxter Healthcare Corporation
Creator: Argus HQ
Published: 2026-07-08
License: https://argushq.ai/methodology

Event date: 2026-07-08 00:00:00Z
Observed: 2026-07-14 04:20:21Z
Source ID: Z-2550-2026
Payload hash: 67a547fb71c6426e3255d164…

Summary

There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the delivery of the prescribed treatment. The issue has been asso… 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 6 total FDA actions tied to Baxter Healthcare Corporation: 0 warning letters, 6 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 2026-07-08; Argus observed and indexed it on 2026-07-14.
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 I recall: Hillrom VOLARA System P.CIRCUIT KIT AC (Single Patient Use Circuit), Model/Catal…. Digital Empire LLC. Retrieved from https://argushq.ai/events/fda-recall-baxter-healthcare-corporation-z-2550-2026

MLA

"Baxter Healthcare Corporation — Class I recall: Hillrom VOLARA System P.CIRCUIT KIT AC (Single Patient Use Circuit), Model/Catal…." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/events/fda-recall-baxter-healthcare-corporation-z-2550-2026.

Chicago

Argus HQ Research. "Baxter Healthcare Corporation — Class I recall: Hillrom VOLARA System P.CIRCUIT KIT AC (Single Patient Use Circuit), Model/Catal…." Digital Empire LLC. Accessed July 14, 2026. https://argushq.ai/events/fda-recall-baxter-healthcare-corporation-z-2550-2026.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_baxter_healthcare_corporation_z_2550_2026_2026,
  title = {Baxter Healthcare Corporation — Class I recall: Hillrom VOLARA System P.CIRCUIT KIT AC (Single Patient Use Circuit), Model/Catal…},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/events/fda-recall-baxter-healthcare-corporation-z-2550-2026},
  note = {Accessed: July 14, 2026}
}

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