Fresenius Medical Care Holdings recalls

Fresenius Medical Care Holdings has 165 recalls on record with the FDA and USDA, the earliest in 2012 and the latest reported on 15 Jul 2026. 90 are still ongoing. 7 were reported in the last 12 months.

Total recalls165since 2012

Last 12 months7reported

Class I1912% of total

Ongoing90latest 15 Jul 2026

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 1Jan '25 0 0 0Apr 0 1 1Jul 0 0 1Oct 0 1 0Jan '26 0 0 0Apr 2 2 1Jul 0 0

Severity split

Class I 19 12%Class II 128 78%Class III 18 11%

Why fresenius medical care holdings is recalled

Product types

Brands

Delflex74%
Sodium Chloride42%

By year

202653%
202553%
20242213%
2023138%
2022148%
20214930%
202064%
201595%
20142314%
20131710%

Ongoing fresenius medical care holdings recalls

90 active

Reported	Class	Recall	Company	Reason	Where
15 Jul 2026Device	CLASS II	5008X Blood Tubing Set recalled by Fresenius Medical Care	Fresenius Medical Care Holdings	Other	Nationwide
17 Jun 2026Device	CLASS II	Bicarby" Dialysate recalled by Fresenius Medical Care	Fresenius Medical Care Holdings	Packaging Defects	Nationwide
17 Jun 2026Device	CLASS II	Bicarby Dialysate recalled by Fresenius Medical Care	Fresenius Medical Care Holdings	Other	TX
13 May 2026Drug	CLASS II	Delflex, Dextrose Peritoneal Dialysis Solution recalled	Fresenius Medical Care Holdings	Sterility	Nationwide
13 May 2026Drug	CLASS II	Delflex, Dextrose Peritoneal Dialysis Solution recalled	Fresenius Medical Care Holdings	Sterility	Nationwide
24 Dec 2025Device	CLASS II	5008X CAREsystem +CLiC +CDX recalled by Fresenius Medical Care	Fresenius Medical Care Holdings	Device Malfunction	LA, MA, MN

All fresenius medical care holdings recalls, newest first

165 total

Reported	Class	Recall	Company	Reason	Where
15 Jul 2026Device	CLASS II	5008X Blood Tubing Set recalled by Fresenius Medical Care	Fresenius Medical Care Holdings	Other	Nationwide
17 Jun 2026Device	CLASS II	Bicarby" Dialysate recalled by Fresenius Medical Care	Fresenius Medical Care Holdings	Packaging Defects	Nationwide
17 Jun 2026Device	CLASS II	Bicarby Dialysate recalled by Fresenius Medical Care	Fresenius Medical Care Holdings	Other	TX
13 May 2026Drug	CLASS II	Delflex, Dextrose Peritoneal Dialysis Solution recalled	Fresenius Medical Care Holdings	Sterility	Nationwide
13 May 2026Drug	CLASS II	Delflex, Dextrose Peritoneal Dialysis Solution recalled	Fresenius Medical Care Holdings	Sterility	Nationwide
24 Dec 2025Device	CLASS II	5008X CAREsystem +CLiC +CDX recalled by Fresenius Medical Care	Fresenius Medical Care Holdings	Device Malfunction	LA, MA, MN
15 Oct 2025Device	CLASS II	Optiflux¿ High Flux E-beam Dialyzer recalled by Fresenius Medical Care	Fresenius Medical Care Holdings	Other	Nationwide
2 Jul 2025Drug	CLASS II	0.9% Sodium Chloride Injection, USP, Flexible recalledSodium Chloride	Fresenius Medical Care Holdings	Sterility	Nationwide
25 Jun 2025Device	CLASS II	5008X HDF Hemodialysis Blood Tubing Set, with the following recalled	Fresenius Medical Care Holdings	Packaging Defects	Nationwide
15 Jan 2025Device	CLASS II	Dialyzer Optiflux 160NRe recalled by Fresenius Medical Care	Fresenius Medical Care Holdings	Packaging Defects	Nationwide
18 Sep 2024Device	CLASS II	Blood Pressure Module BPM3 TM-2917B recalled by Fresenius Medical Care	Fresenius Medical Care Holdings	Device Malfunction	Nationwide
24 Jul 2024Drug	CLASS II	Delflex Peritoneal Dialysis Solution With Low Magnesium recalledDelflex	Fresenius Medical Care Holdings	Packaging Defects	Nationwide
17 Jul 2024Device	CLASS II	RTL190828: 2008K@Home Hemodialysis System recalled	Fresenius Medical Care Holdings	Other	Nationwide
17 Jul 2024Device	CLASS II	191014: 2008K@Home HD System W/Bibag (Canada) recalled	Fresenius Medical Care Holdings	Other	Nationwide
17 Jul 2024Device	CLASS II	RTL190904: 2008K@Home Hemodialysis System W/ Bibag recalled	Fresenius Medical Care Holdings	Other	Nationwide
17 Jul 2024Device	CLASS II	190828: 2008K@Home Hemodialysis System - Blood Pump Rotor spare part recalled	Fresenius Medical Care Holdings	Other	Nationwide
17 Jul 2024Device	CLASS II	190395: 2008K@Home Machine, Short Cab,Olc/DP,HP recalled	Fresenius Medical Care Holdings	Other	Nationwide
17 Jul 2024Device	CLASS II	190904 2008K@Home Hemodialysis System W/ Bibag recalled	Fresenius Medical Care Holdings	Other	Nationwide
17 Jul 2024Device	CLASS II	RTLR190395: 2008K@Home Machine, Short Cab,Olc/DP,HP recalled	Fresenius Medical Care Holdings	Other	Nationwide
17 Jul 2024Device	CLASS II	RTL190395: 2008K@Home Machine, Short Cab,Olc/DP,HP recalled	Fresenius Medical Care Holdings	Other	Nationwide
19 Jun 2024Device	CLASS II	US AquaA 900H-Typ USA-3 x 208v-Intended recalled	Fresenius Medical Care Holdings	Device Malfunction	Nationwide
29 May 2024Device	CLASS II	2008T BlueStar Hemodialysis Machine recalled by Fresenius Medical Care	Fresenius Medical Care Holdings	Other	Nationwide
29 May 2024Device	CLASS II	2008T BlueStar Hemodialysis Machine recalled by Fresenius Medical Care	Fresenius Medical Care Holdings	Other	Nationwide
29 May 2024Device	CLASS II	Blood Pump Rotor recalled by Fresenius Medical Care	Fresenius Medical Care Holdings	Other	Nationwide
22 May 2024Device	CLASS II	Novalung sensor box is a component of the Novalung Console recalled	Fresenius Medical Care Holdings	Device Malfunction	Nationwide
3 Apr 2024Device	CLASS I	stay-safe /Safe Lock Catheter Ext recalled by Fresenius Medical Care	Fresenius Medical Care Holdings	Other	Nationwide
3 Apr 2024Device	CLASS I	stay-safe /Luer Lock Catheter Ext recalled by Fresenius Medical Care	Fresenius Medical Care Holdings	Other	Nationwide
3 Apr 2024Device	CLASS I	stay-safe /Luer Catheter Ext recalled by Fresenius Medical Care	Fresenius Medical Care Holdings	Other	Nationwide
3 Apr 2024Device	CLASS I	stay-safe /Luer Lock Catheter Ext recalled by Fresenius Medical Care	Fresenius Medical Care Holdings	Other	Nationwide
3 Apr 2024Device	CLASS I	stay-safe /Luer Lock Adapter recalled by Fresenius Medical Care	Fresenius Medical Care Holdings	Other	Nationwide

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.