FDA Actions Against Fresenius Medical Care Renal Therapies Group, LLC

FDA action counts

Risk pattern analysis

Argus HQ analysis — not an FDA finding

This section is Argus HQ analysis, not an FDA finding. Fresenius Medical Care Renal Therapies Group, LLC has 1 FDA event on file. A pattern across multiple FDA touchpoints does not by itself establish that any specific product currently poses a risk; it reflects only the frequency of FDA engagement with this company as recorded in Argus HQ's database. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ does not independently verify FDA's underlying findings; this page summarizes what FDA has published and links back to the original FDA source for each event. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

Enforcement history

On 2026-09-02, Argus HQ recorded an FDA recall for Fresenius Medical Care Renal Therapies Group, LLC, rated "high" severity in Argus HQ's classification: Fresenius Medical Care Renal Therapies Group, LLC — Class II recall: Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: 191…. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed.

Frequently asked questions

Does Argus HQ track new FDA actions for Fresenius Medical Care Renal Therapies Group, LLC automatically?

Yes. Argus HQ ingests FDA sources daily, including FDA warning letters, recalls, drug and biologic approvals, and Form 483 inspection observations. When a new FDA action linked to Fresenius Medical Care Renal Therapies Group, LLC is observed, this page's event count and history update automatically.

How many FDA actions does Argus HQ track for Fresenius Medical Care Renal Therapies Group, LLC?

8 total: 0 warning letters, 8 recalls, 0 approval records, and 0 Form 483 inspection citations.

What is the most recent FDA action on file for Fresenius Medical Care Renal Therapies Group, LLC?

September 9, 2026. Argus HQ ingests new FDA enforcement records daily.

Has Fresenius Medical Care Renal Therapies Group, LLC had product recalls?

Yes, 8 recalls on file. See the full history below for each one.

Related enforcement actions

• Fresenius Medical Care Renal Therapies Group, LLC — Class II recall: 5008X HD/HDF Standard Blood Tubing Set Part Number 03-5300-3 →
• Fresenius Medical Care Renal Therapies Group, LLC — Class II recall: 5008X HD/HDF with CLiC Blood Tubing Set Part number 03-5300-3C →
• Fresenius Medical Care Renal Therapies Group, LLC — Class II recall: 5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8 →
• Fresenius Medical Care Renal Therapies Group, LLC — Class II recall: Citrasate, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Number… →
• Fresenius Medical Care Renal Therapies Group, LLC — Class II recall: NaturaLyte, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbe… →
• Fresenius Medical Care Renal Therapies Group, LLC — Class II recall: GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B; 0FD3251-3B; Dry Ac… →
• Fresenius Medical Care Renal Therapies Group, LLC — Class II recall: 5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-… →
• Fresenius Medical Care Renal Therapies Group, LLC — Class II recall: Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: 191… →

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