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fda_recall · device_recall · high

Baxter Healthcare Corporation — Class II recall: Automated Peritoneal Dialysis System. Used for automatic control of dialysis so…

Event date
2023-04-05 00:00:00Z
Observed
2026-07-16 23:20:10Z
Source ID
Z-1316-2023
Payload hash
82e7bf006ca563a0a1c2473f

Summary

The electrical safety testing was not properly performed on the impacted devices and additional testing is required 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 high severity by Argus HQ. FDA published the underlying record on 2023-04-05; 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 (2023). Baxter Healthcare Corporation — Class II recall: Automated Peritoneal Dialysis System.  Used for automatic control of dialysis so…. Digital Empire LLC. Retrieved from https://argushq.ai/events/fda-recall-baxter-healthcare-corporation-z-1316-2023
MLA
"Baxter Healthcare Corporation — Class II recall: Automated Peritoneal Dialysis System.  Used for automatic control of dialysis so…." Argus HQ Research, Digital Empire LLC, 2023, argushq.ai/events/fda-recall-baxter-healthcare-corporation-z-1316-2023.
Chicago
Argus HQ Research. "Baxter Healthcare Corporation — Class II recall: Automated Peritoneal Dialysis System.  Used for automatic control of dialysis so…." Digital Empire LLC. Accessed July 17, 2026. https://argushq.ai/events/fda-recall-baxter-healthcare-corporation-z-1316-2023.
BibTeX
@misc{argushq_argushq_ai_events_fda_recall_baxter_healthcare_corporation_z_1316_2023_2023,
  title = {Baxter Healthcare Corporation — Class II recall: Automated Peritoneal Dialysis System.  Used for automatic control of dialysis so…},
  author = {{Argus HQ Research}},
  year = {2023},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/events/fda-recall-baxter-healthcare-corporation-z-1316-2023},
  note = {Accessed: July 17, 2026}
}

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