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 high severity by Argus HQ. FDA published the underlying record on 2024-01-17; 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 · high

Baxter Healthcare Corporation — Class II recall: Baxter Preveleak Surgical Sealant, Product Codes: ADS201808

Name: FDA Recall Record — Baxter Healthcare Corporation
Creator: Argus HQ
Published: 2024-01-17
License: https://argushq.ai/methodology

Event date: 2024-01-17 00:00:00Z
Observed: 2026-07-16 23:20:10Z
Source ID: Z-0660-2024
Payload hash: 423a98c58bff851cc2b01497…

Summary

Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI). 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 high severity by Argus HQ. FDA published the underlying record on 2024-01-17; 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 (2024). Baxter Healthcare Corporation — Class II recall: Baxter Preveleak Surgical Sealant, Product Codes:  ADS201808. Digital Empire LLC. Retrieved from https://argushq.ai/events/fda-recall-baxter-healthcare-corporation-z-0660-2024

MLA

"Baxter Healthcare Corporation — Class II recall: Baxter Preveleak Surgical Sealant, Product Codes:  ADS201808." Argus HQ Research, Digital Empire LLC, 2024, argushq.ai/events/fda-recall-baxter-healthcare-corporation-z-0660-2024.

Chicago

Argus HQ Research. "Baxter Healthcare Corporation — Class II recall: Baxter Preveleak Surgical Sealant, Product Codes:  ADS201808." Digital Empire LLC. Accessed July 17, 2026. https://argushq.ai/events/fda-recall-baxter-healthcare-corporation-z-0660-2024.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_baxter_healthcare_corporation_z_0660_2024_2024,
  title = {Baxter Healthcare Corporation — Class II recall: Baxter Preveleak Surgical Sealant, Product Codes:  ADS201808},
  author = {{Argus HQ Research}},
  year = {2024},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/events/fda-recall-baxter-healthcare-corporation-z-0660-2024},
  note = {Accessed: July 17, 2026}
}

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