Fresenius Medical Care Holdings, Inc.
Waltham, MA, United States
This page shows every FDA and USDA recall linked to Fresenius Medical Care Holdings, Inc.. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
168
Total Recalls
2010
First Recall
2025
Most Recent
Drug: 9
Device: 159
Class II: 8
Class III: 1
5008X CAREsystem +CLiC +CDX;
Dec 17, 2025
· Device
Active
0.9% Sodium Chloride Injection, USP, Flexible Plastic Container, Rx Only Fresenius Medical Care North America,...
Jul 2, 2025
· Drug
Class II
Active
5008X HDF Hemodialysis Blood Tubing Set, 24 units per case, with the following models:
a. 5008X Standard HDF...
Jun 18, 2025
· Device
Active
Dialyzer Optiflux 160NRe
Jan 3, 2025
· Device
Active
Blood Pressure Module BPM3 TM-2917B (Spare Part Numbers 191378 or 191389) with firmware version S005 installed...
Sep 11, 2024
· Device
Active
DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW CALCIUM 4.25% DEXTROSE and attached stay "safe E...
Jul 24, 2024
· Drug
Class II
Active
RTLR190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev...
Jul 11, 2024
· Device
Active
190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
Jul 11, 2024
· Device
Active
RTL190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
Jul 11, 2024
· Device
Active
RTL190904: 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev...
Jul 11, 2024
· Device
Active
190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
Jul 11, 2024
· Device
Active
190904 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
Jul 11, 2024
· Device
Active
191014: 2008K@HOME HD SYSTEM W/BIBAG (CANADA) - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
Jul 11, 2024
· Device
Active
RTL190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev...
Jul 11, 2024
· Device
Active
US AquaA 900H-Typ USA-3 x 208v-Intended for the purification of water to be used for hemodialysis
Vivonic Part...
Jun 13, 2024
· Device
Active
Blood Pump Rotor, Model Number: F40015481 Rev A
May 17, 2024
· Device
Active
2008T BlueStar Hemodialysis Machine, Model 191126 with Component: Blood Pump Rotor, Model Number: F40015481 Re...
May 17, 2024
· Device
Active
2008T BlueStar Hemodialysis Machine, Model 191130 with Component: Blood Pump Rotor, Model Number: F40015481 Re...
May 17, 2024
· Device
Active
2008T BlueStar Hemodialysis Machine, Model 191124 with Component: Blood Pump Rotor, Model Number: F40015481 Re...
May 17, 2024
· Device
Active
2008T BlueStar Hemodialysis Machine, Model 191128 with Component: Blood Pump Rotor, Model Number: F40015481 Re...
May 17, 2024
· Device
Active
Novalung sensor box is a component of the Novalung Console (F30000162)-Indicated for long-term (> 6 hours) res...
May 15, 2024
· Device
Active
stay-safe /Luer Lock Catheter Ext. 12 in
Mar 26, 2024
· Device
Active
stay-safe /Luer Lock Adapter 4 in
Mar 26, 2024
· Device
Active
stay-safe /Safe Lock Catheter Ext. 12 in
Mar 26, 2024
· Device
Active
stay-safe /Luer Lock Catheter Ext. 18 in
Mar 26, 2024
· Device
Active
stay-safe /Luer Catheter Ext. 6 in
Mar 26, 2024
· Device
Active
DELFLEX Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose, packaged in 6000mL bags, Rx only, Fre...
Jan 10, 2024
· Drug
Class II
Active
Liberty Select Cycler, Model numbers RTLR180343 and RTLR180111
Dec 26, 2023
· Device
Active
Stay Safe Cap
Dec 7, 2023
· Device
Active
2008T Hemodialysis SYS, with CDX
Oct 6, 2023
· Device
Active
2008T Hemodialysis System without CDX
Oct 6, 2023
· Device
Active
10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case
Oct 6, 2023
· Device
Active
10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
Oct 6, 2023
· Device
Active
2008T HD SYS. W/O CDX BLUESTAR
Oct 6, 2023
· Device
Active
2008T HD SYS. CDX BLUESTAR
Oct 6, 2023
· Device
Active
2008T GEN 2 Bibag without CDX
Oct 6, 2023
· Device
Active
2008T HD SYS. CDX W/BIBAG BLUESTAR
Oct 6, 2023
· Device
Active
2008T HD SYS. W/O CDX W/BIBAG BLUESTAR
Oct 6, 2023
· Device
Active
2008T Hemodialysis System w/Bibag
Oct 6, 2023
· Device
Active
3ML Syringe Luer Lock with needle 20GX1, Part Number 15-03ML-0, 100 per box, 24 boxes per case
Oct 6, 2023
· Device
Active
Sodium Chloride 0.9% Injection, USP, 1000 mL bags, 12 bags per carton, Rx only, Fresenius Medical Care North A...
Jun 7, 2023
· Drug
Class II
Terminated
2008T and 2008TBluestar Hemodialysis Machines with CDX-Indicated for acute and chronic dialysis therapy in a...
Dec 20, 2022
· Device
Active
0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION,...
Dec 14, 2022
· Drug
Class II
Active
NaturaLyte Liquid Acid concentrate, Part Number 08-0231-4, four (4) one-gallon bottles per bottle case. For d...
Nov 4, 2022
· Device
Active
0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION,...
Oct 26, 2022
· Drug
Class II
Active
AquaC UNO H [120V, 60Hz, 1000VA, US-Version - a reverse osmosis unit intended for use with hemodialysis system...
Sep 19, 2022
· Device
Active
AquaC UNO H [120V, 60Hz, 1700VA, US-Version- a reverse osmosis unit intended for use with hemodialysis systems...
Sep 19, 2022
· Device
Active
AquaC UNO H [120V, 60Hz, 1000VA,
Fresenius US-Version: 24-10VA-1
Vivonic Part Number: G02000970-US
Jul 25, 2022
· Device
Active
AquaC UNO H [120V, 60Hz, 1700VA,
Fresenius US-Version: 24-0970-1
Vivonic Part Number: G02000966-US
Jul 25, 2022
· Device
Active