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fda_recall · device_recall · high

Fresenius Medical Care Renal Therapies Group, LLC — Class II recall: Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: 191…

Event date
2026-09-02 00:00:00Z
Observed
2026-09-08 04:20:25Z
Source ID
Z-3017-2026
Payload hash
db3ad1df105c0a152f5a20e9

Summary

Fresenius Medical Care Renal Therapies Group, LLC (FMCRTG) has received complaints regarding flow-, no water-, or temperature-related alarms with the 2008T¿ BlueStar Hemodialysis machines. Status: Ongoing.

Frequently asked questions

Has Fresenius Medical Care Renal Therapies Group, LLC had other FDA enforcement actions?
Yes. Argus HQ has recorded 8 total FDA actions tied to Fresenius Medical Care Renal Therapies Group, LLC: 0 warning letters, 8 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 2026-09-02; Argus observed and indexed it on 2026-09-08.
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). Fresenius Medical Care Renal Therapies Group, LLC — Class II recall: Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers:  191…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-fresenius-medical-care-renal-therapies-group-llc-z-3017-2026
MLA
"Fresenius Medical Care Renal Therapies Group, LLC — Class II recall: Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers:  191…." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-fresenius-medical-care-renal-therapies-group-llc-z-3017-2026.
Chicago
Argus HQ Research. "Fresenius Medical Care Renal Therapies Group, LLC — Class II recall: Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers:  191…." Digital Empire Holdings LLC. Accessed September 15, 2026. https://argushq.ai/events/fda-recall-fresenius-medical-care-renal-therapies-group-llc-z-3017-2026.
BibTeX
@misc{argushq_argushq_ai_events_fda_recall_fresenius_medical_care_renal_therapies_group_llc_z_3017_2026_2026,
  title = {Fresenius Medical Care Renal Therapies Group, LLC — Class II recall: Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers:  191…},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-fresenius-medical-care-renal-therapies-group-llc-z-3017-2026},
  note = {Accessed: September 15, 2026}
}

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