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 2026-09-09; Argus observed and indexed it on 2026-09-15.

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

Fresenius Medical Care Renal Therapies Group, LLC — Class II recall: 5008X HD/HDF Standard Blood Tubing Set Part Number 03-5300-3

Name: FDA Recall Record — Fresenius Medical Care Renal Therapies Group, LLC
Creator: Argus HQ
Published: 2026-09-09
License: https://argushq.ai/methodology

Event date: 2026-09-09 00:00:00Z
Observed: 2026-09-15 04:20:29Z
Source ID: Z-3085-2026
Payload hash: 138d14251598d24c5136834b…

Summary

Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia. Status: Ongoing.

Entities

Fresenius Medical Care Renal Therapies Group, LLC

View source record ↗

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 2026-09-09; Argus observed and indexed it on 2026-09-15.
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: 5008X HD/HDF   Standard Blood  Tubing Set    Part Number 03-5300-3. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-fresenius-medical-care-renal-therapies-group-llc-z-3085-2026

MLA

"Fresenius Medical Care Renal Therapies Group, LLC — Class II recall: 5008X HD/HDF   Standard Blood  Tubing Set    Part Number 03-5300-3." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-fresenius-medical-care-renal-therapies-group-llc-z-3085-2026.

Chicago

Argus HQ Research. "Fresenius Medical Care Renal Therapies Group, LLC — Class II recall: 5008X HD/HDF   Standard Blood  Tubing Set    Part Number 03-5300-3." Digital Empire Holdings LLC. Accessed September 15, 2026. https://argushq.ai/events/fda-recall-fresenius-medical-care-renal-therapies-group-llc-z-3085-2026.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_fresenius_medical_care_renal_therapies_group_llc_z_3085_2026_2026,
  title = {Fresenius Medical Care Renal Therapies Group, LLC — Class II recall: 5008X HD/HDF   Standard Blood  Tubing Set    Part Number 03-5300-3},
  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-3085-2026},
  note = {Accessed: September 15, 2026}
}

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