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GranuFloRecalls & reported problems across all models

Fresenius Medical Care Renal Therapies Group, LLC · 2 models in the FDA device registry

Data updated Oct 18, 2026 from official FDA records · Editorial policy

1 open recall names at least one GranuFlo model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.

Adverse event reports
21
Deaths reported
2
Injuries reported
19
Recalls
3

We found 2 models of GranuFlo by Fresenius Medical Care Renal Therapies Group, LLC in the FDA's device registry (GUDID). Together they are named in 21 adverse event reports in the FDA's MAUDE database, received between Jun 26, 2017 and Jul 19, 2019 — classified as 2 deaths, 19 injuries.

3 FDA recall records name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

GranuFlo recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

  1. Jul 14, 2026Class IIOpen, Classified

    Complaints of blue-green discoloration in product

    Z-3091-2026 · Root cause: Material/Component Contamination · names 2 of these models · Recall details · FDA record ↗

  2. Apr 28, 2021Class IITerminated

    Exposed to freezing temperatures due to refrigerated truck malfunctions

    Z-2086-2021 · Root cause: Environmental control · Recall details · FDA record ↗

  3. Apr 28, 2021Class IITerminated

    Exposed to freezing temperatures due to refrigerated truck malfunctions

    Z-2084-2021 · Root cause: Environmental control · Recall details · FDA record ↗

Most reported GranuFlo problems

Device problems

  • Adverse Event Without Identified Device or Use Problem21

Patient problems

  • Hemolysis14
  • Electrolyte Imbalance4
  • Cardiac Arrest2
  • Death2
  • Loss of consciousness1

GranuFlo models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

Recent GranuFlo adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

Other Fresenius Medical Care Renal Therapies Group, LLC products

All Fresenius Medical Care Renal Therapies Group, LLC devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page