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 2024-03-20; 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: STERIS Boot Assembly, Traction Device, OT 1000, Part Number REF 10009192

Name: FDA Recall Record — Baxter Healthcare Corporation
Creator: Argus HQ
Published: 2024-03-20
License: https://argushq.ai/methodology

Event date: 2024-03-20 00:00:00Z
Observed: 2026-07-16 23:20:10Z
Source ID: Z-1289-2024
Payload hash: f14834cca4389950dbfdc99e…

Summary

Three lots of the Boot Assembly, Traction Device are being recalled due to due to a customer report of an incorrectly oriented locking pin which caused the boot to detach from the traction system. If an impacted device is used during surgery, the boot may detach from the traction system, potentially… 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 2024-03-20; 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: STERIS Boot Assembly, Traction Device, OT 1000, Part Number REF 10009192. Digital Empire LLC. Retrieved from https://argushq.ai/events/fda-recall-baxter-healthcare-corporation-z-1289-2024

MLA

"Baxter Healthcare Corporation — Class II recall: STERIS Boot Assembly, Traction Device, OT 1000, Part Number REF 10009192." Argus HQ Research, Digital Empire LLC, 2024, argushq.ai/events/fda-recall-baxter-healthcare-corporation-z-1289-2024.

Chicago

Argus HQ Research. "Baxter Healthcare Corporation — Class II recall: STERIS Boot Assembly, Traction Device, OT 1000, Part Number REF 10009192." Digital Empire LLC. Accessed July 17, 2026. https://argushq.ai/events/fda-recall-baxter-healthcare-corporation-z-1289-2024.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_baxter_healthcare_corporation_z_1289_2024_2024,
  title = {Baxter Healthcare Corporation — Class II recall: STERIS Boot Assembly, Traction Device, OT 1000, Part Number REF 10009192},
  author = {{Argus HQ Research}},
  year = {2024},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/events/fda-recall-baxter-healthcare-corporation-z-1289-2024},
  note = {Accessed: July 17, 2026}
}

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