Fresenius Medical Care Renal Therapies Group recalls

Fresenius Medical Care Renal Therapies Group has 34 recalls on record with the FDA and USDA, the earliest in 2015 and the latest reported on 9 Sep 2026. 8 are still ongoing. 8 were reported in the last 12 months.

Total recalls34since 2015

Last 12 months8reported

Class I00% of total

Ongoing8latest 9 Sep 2026

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 8

Severity split

Class I 0 0%Class II 30 88%Class III 4 12%

Why fresenius medical care renal therapies group is recalled

Product types

By year

2026824%
201926%
20181235%
2017412%
2016515%
201539%

Ongoing fresenius medical care renal therapies group recalls

8 active

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	5008X HD/HDF with CLiC Blood Tubing Set recalled	Fresenius Medical Care Renal Therapies Group	Packaging Defects	Nationwide
9 Sep 2026Device	CLASS II	5008X HD/HDF Standard Blood Tubing Set recalled	Fresenius Medical Care Renal Therapies Group	Packaging Defects	Nationwide
9 Sep 2026Device	CLASS II	Citrasate, Liquid Acid Concentrate recalled	Fresenius Medical Care Renal Therapies Group	Other	Nationwide
9 Sep 2026Device	CLASS II	NaturaLyte, Liquid Acid Concentrate recalled	Fresenius Medical Care Renal Therapies Group	Other	Nationwide
9 Sep 2026Device	CLASS II	Granuflo Dry Acid Concentrate: Product Numbers: 0FD2251-3B recalled	Fresenius Medical Care Renal Therapies Group	Other	Nationwide
9 Sep 2026Device	CLASS II	5008X Standard HD Pre-Flush Standard Blood Tubing Set recalled	Fresenius Medical Care Renal Therapies Group	Packaging Defects	Nationwide

All fresenius medical care renal therapies group recalls, newest first

34 total

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	5008X HD/HDF with CLiC Blood Tubing Set recalled	Fresenius Medical Care Renal Therapies Group	Packaging Defects	Nationwide
9 Sep 2026Device	CLASS II	5008X HD/HDF Standard Blood Tubing Set recalled	Fresenius Medical Care Renal Therapies Group	Packaging Defects	Nationwide
9 Sep 2026Device	CLASS II	Citrasate, Liquid Acid Concentrate recalled	Fresenius Medical Care Renal Therapies Group	Other	Nationwide
9 Sep 2026Device	CLASS II	NaturaLyte, Liquid Acid Concentrate recalled	Fresenius Medical Care Renal Therapies Group	Other	Nationwide
9 Sep 2026Device	CLASS II	Granuflo Dry Acid Concentrate: Product Numbers: 0FD2251-3B recalled	Fresenius Medical Care Renal Therapies Group	Other	Nationwide
9 Sep 2026Device	CLASS II	5008X Standard HD Pre-Flush Standard Blood Tubing Set recalled	Fresenius Medical Care Renal Therapies Group	Packaging Defects	Nationwide
9 Sep 2026Device	CLASS II	5008X HD/HDF with Twister Blood Tubing Set recalled	Fresenius Medical Care Renal Therapies Group	Packaging Defects	Nationwide
2 Sep 2026Device	CLASS II	Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine recalled	Fresenius Medical Care Renal Therapies Group	Temperature Abuse	Nationwide
14 Aug 2019Device	CLASS II	Liberty Cycler Cassettes (a disposable cassette recalled	Fresenius Medical Care Renal Therapies Group	Packaging Defects	Nationwide
12 Jun 2019Device	CLASS III	2008T BlueStar Machine recalled by Fresenius Medical Care Renal	Fresenius Medical Care Renal Therapies Group	Device Malfunction	Nationwide
26 Dec 2018Device	CLASS II	Optiflux F160NR Capillary High Flux Dialyzer Single Use recalled	Fresenius Medical Care Renal Therapies Group	Packaging Defects	Nationwide
5 Dec 2018Device	CLASS III	Fresenius Granuflo Dry Acid Concentrate- 3K 2.5 Ca 1 Mg recalled	Fresenius Medical Care Renal Therapies Group	Other	Nationwide
5 Dec 2018Device	CLASS III	Fresenius Granuflo Dry Acid Concentrate- 2K 2.5 Ca 1 Mg recalled	Fresenius Medical Care Renal Therapies Group	Other	Nationwide
5 Dec 2018Device	CLASS III	Fresenius Granuflo Dry Acid Concentrate- 2K 2.0 Ca 1 Mg recalled	Fresenius Medical Care Renal Therapies Group	Other	Nationwide
26 Sep 2018Device	CLASS II	2008t Hemodialysis Sys, With Cdx recalled	Fresenius Medical Care Renal Therapies Group	Device Malfunction	Nationwide
26 Sep 2018Device	CLASS II	2008t Hemodialysis System W/bibag recalled	Fresenius Medical Care Renal Therapies Group	Device Malfunction	Nationwide
13 Jun 2018Device	CLASS II	NaturaLyte¿ Liquid Acid Concentrate for Bicarbonate Dialysis recalled	Fresenius Medical Care Renal Therapies Group	Labeling Errors	Nationwide
30 May 2018Drug	CLASS II	0.9% Sodium Chloride Injection recalled by Fresenius Medical Care Renal	Fresenius Medical Care Renal Therapies Group	Sterility	Nationwide
11 Apr 2018Device	CLASS II	2008 K2 Hemodialysis Machine recalled by Fresenius Medical Care Renal	Fresenius Medical Care Renal Therapies Group	Device Malfunction	16 states
28 Mar 2018Drug	CLASS II	Delflex Peritoneal Dialysis Solution, 2.5% Low Mg/Low Ca Single recalledDelflex	Fresenius Medical Care Renal Therapies Group	Sterility	Nationwide
21 Mar 2018Device	CLASS II	NaturaLyte¿ Liquid Acid Concentrate 2.0 mEq/L recalled	Fresenius Medical Care Renal Therapies Group	Other	5 states
7 Mar 2018Device	CLASS II	2008T, Hemodialysis Delivery System Product Indicated recalled	Fresenius Medical Care Renal Therapies Group	Device Malfunction	Nationwide
25 Jan 2017Device	CLASS II	Fresenius 2008K Series : Hemodialysis System recalled	Fresenius Medical Care Renal Therapies Group	Other	Nationwide
25 Jan 2017Device	CLASS II	Fresenius 2008T Series Hemodialysis System recalled	Fresenius Medical Care Renal Therapies Group	Other	Nationwide
25 Jan 2017Device	CLASS II	Fresenius 2008K2 Series : Hemodialysis System recalled	Fresenius Medical Care Renal Therapies Group	Other	Nationwide
25 Jan 2017Device	CLASS II	Fresenius 2008K@home Series : Hemodialysis System recalled	Fresenius Medical Care Renal Therapies Group	Other	Nationwide
29 Jun 2016Device	CLASS II	Crit Line in a Clip (CLiC) recalled by Fresenius Medical Care Renal	Fresenius Medical Care Renal Therapies Group	Other	Nationwide
13 Apr 2016Device	CLASS II	Fresenius Hemoflow F3 Dialyzer recalled by Fresenius Medical Care Renal	Fresenius Medical Care Renal Therapies Group	Packaging Defects	Nationwide
13 Apr 2016Device	CLASS II	Fresenius 2008 Series Hemodialysis Delivery Systems: 2008T recalled	Fresenius Medical Care Renal Therapies Group	Packaging Defects	Nationwide
2 Mar 2016Device	CLASS II	Fresenius Naturalyte Liquid Acid Concentrate recalled	Fresenius Medical Care Renal Therapies Group	Other	5 states

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.