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Fresenius Medical Care Holdings, Inc. Recalls

112 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Fresenius Medical Care Holdings, Inc..

112Total Recalls
10Critical
55.8MUnits Affected
Apr 6, 2026Most Recent
All Recalls

Every Fresenius Medical Care Holdings, Inc. Recall

Sorted by most recent. Click any recall for full details.

112 recalls
High RiskFDA
Fresenius Medical Care Holdings, Inc.
DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 2.5% DEX. LM/LC, 2...
Drugs·43,225 affected·Apr 6, 2026
High RiskFDA
Fresenius Medical Care Holdings, Inc.
DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 1.5% DEX. LM/LC, ...
Drugs·37,215 affected·Apr 6, 2026
High RiskFDA
Fresenius Medical Care Holdings, Inc.
5008X CAREsystem +CLiC +CDX;
Medical Devices·115 affected·Oct 25, 2025
High RiskFDA
Fresenius Medical Care Holdings, Inc.
0.9% Sodium Chloride Injection, USP, Flexible Plastic Container, Rx Only Fresenius Medical Care North America, Waltham, MA 02451, 1-800-3...
Injectable Drugs·3,651,468 affected·May 27, 2025
High RiskFDA
Fresenius Medical Care Holdings, Inc.
DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW CALCIUM 4.25% DEXTROSE and attached stay "safe Exchange Set, 2500mL (Approx...
Drugs·183 affected·Jun 18, 2024
High RiskFDA
Fresenius Medical Care Holdings, Inc.
RTL190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
Medical Devices·17 affected·Jun 3, 2024
High RiskFDA
Fresenius Medical Care Holdings, Inc.
RTLR190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
Medical Devices·6 affected·Jun 3, 2024
High RiskFDA
Fresenius Medical Care Holdings, Inc.
190904 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
Medical Devices·372 affected·Jun 3, 2024
High RiskFDA
Fresenius Medical Care Holdings, Inc.
190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
Medical Devices·1,156 affected·Jun 3, 2024
High RiskFDA
Fresenius Medical Care Holdings, Inc.
190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
Medical Devices·531 affected·Jun 3, 2024
High RiskFDA
Fresenius Medical Care Holdings, Inc.
RTL190904: 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
Medical Devices·2 affected·Jun 3, 2024
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Blood Pump Rotor, Model Number: F40015481 Rev A
Medical Devices·45,880 affected·Apr 17, 2024
High RiskFDA
Fresenius Medical Care Holdings, Inc.
2008T BlueStar Hemodialysis Machine, Model 191126 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
Medical Devices·12,292 affected·Apr 17, 2024
High RiskFDA
Fresenius Medical Care Holdings, Inc.
2008T BlueStar Hemodialysis Machine, Model 191128 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
Medical Devices·334 affected·Apr 17, 2024
High RiskFDA
Fresenius Medical Care Holdings, Inc.
2008T BlueStar Hemodialysis Machine, Model 191124 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
Medical Devices·931 affected·Apr 17, 2024
High RiskFDA
Fresenius Medical Care Holdings, Inc.
2008T BlueStar Hemodialysis Machine, Model 191130 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A
Medical Devices·11,371 affected·Apr 17, 2024
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Novalung sensor box is a component of the Novalung Console (F30000162)-Indicated for long-term (> 6 hours) respiratory/ cardiopulmonary s...
Respiratory Devices·88 affected·Apr 8, 2024
CriticalFDA
Fresenius Medical Care Holdings, Inc.
stay-safe /Luer Lock Adapter 4 in
Medical Devices·828,954 affected·Jan 23, 2024
CriticalFDA
Fresenius Medical Care Holdings, Inc.
stay-safe /Luer Lock Catheter Ext. 18 in
Surgical Devices·479,978 affected·Jan 23, 2024
CriticalFDA
Fresenius Medical Care Holdings, Inc.
stay-safe /Luer Catheter Ext. 6 in
Surgical Devices·105,700 affected·Jan 23, 2024
High RiskFDA
Fresenius Medical Care Holdings, Inc.
DELFLEX Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose, packaged in 6000mL bags, Rx only, Fresenius Medical Care NA Walt...
Drugs·69,590 affected·Dec 28, 2023
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Stay Safe Cap
Medical Devices·18,236,160 affected·Oct 10, 2023
CriticalFDA
Fresenius Medical Care Holdings, Inc.
2008T HD SYS. W/O CDX BLUESTAR
Medical Devices·733 affected·Sep 6, 2023
CriticalFDA
Fresenius Medical Care Holdings, Inc.
2008T Hemodialysis SYS, with CDX
Medical Devices·703 affected·Sep 6, 2023
CriticalFDA
Fresenius Medical Care Holdings, Inc.
2008T HD SYS. W/O CDX W/BIBAG BLUESTAR
Medical Devices·733 affected·Sep 6, 2023
CriticalFDA
Fresenius Medical Care Holdings, Inc.
3ML Syringe Luer Lock with needle 20GX1, Part Number 15-03ML-0, 100 per box, 24 boxes per case
Medical Devices·124,773 affected·Aug 8, 2023
CriticalFDA
Fresenius Medical Care Holdings, Inc.
10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case
Medical Devices·124,773 affected·Aug 8, 2023
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Sodium Chloride 0.9% Injection, USP, 1000 mL bags, 12 bags per carton, Rx only, Fresenius Medical Care North America, Waltham, MA 02451, ...
Injectable Drugs·53,424 affected·May 23, 2023
High RiskFDA
Fresenius Medical Care Holdings, Inc.
0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs, 1000mL Bag, 12 P...
Injectable Drugs·4,097 affected·Nov 22, 2022
High RiskFDA
Fresenius Medical Care Holdings, Inc.
0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs, 1000mL Bag, 12 P...
Injectable Drugs·16,006 affected·Oct 11, 2022
High RiskFDA
Fresenius Medical Care Holdings, Inc.
NaturaLyte Liquid Acid concentrate, Part Number 08-0231-4, four (4) one-gallon bottles per bottle case. For dialysis.
Medical Devices·17,700 affected·Oct 4, 2022
High RiskFDA
Fresenius Medical Care Holdings, Inc.
2008T and 2008TBluestar Hemodialysis Machines with CDX-Indicated for acute and chronic dialysis therapy in a healthcare facility Models...
Medical Devices·2,008 affected·Jul 27, 2022
High RiskFDA
Fresenius Medical Care Holdings, Inc.
AquaC UNO H [120V, 60Hz, 1000VA, US-Version - a reverse osmosis unit intended for use with hemodialysis systems. Fresenius Part Numbe...
Medical Devices·24 affected·Jun 21, 2022
High RiskFDA
Fresenius Medical Care Holdings, Inc.
AquaC UNO H [120V, 60Hz, 1700VA, Fresenius US-Version: 24-0970-1 Vivonic Part Number: G02000966-US
Medical Devices·277 affected·Jun 16, 2022
High RiskFDA
Fresenius Medical Care Holdings, Inc.
AquaC UNO H [120V, 60Hz, 1000VA, Fresenius US-Version: 24-10VA-1 Vivonic Part Number: G02000970-US
Medical Devices·318 affected·Jun 16, 2022
High RiskFDA
Fresenius Medical Care Holdings, Inc.
NATURALYTE Liquid Acid 3.0K 3.0Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic...
Medical Devices·163 affected·May 31, 2022
High RiskFDA
Fresenius Medical Care Holdings, Inc.
NATURALYTE Liquid Acid 2.0K 2.5Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic...
Medical Devices·656 affected·May 31, 2022
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Optiflux 200NRe Dialyzer Finished Assy., Model no. 0500320E
Medical Devices·19 affected·May 4, 2022
High RiskFDA
Fresenius Medical Care Holdings, Inc.
AquaBplus Water Purification System, Part Number 24-2000-0, AquaBplus 2500 - Typ USA (G02040108-US), AquaBplus 2000 - Typ USA (G02040114-...
Medical Devices·2 affected·Aug 3, 2021
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Sodium Chloride 0.9%, USP, 1000 mL, Mfg by: Fresenius Medical Care North America, Waltham, MA 02451, NDC 46163-0300-10
Drugs·48 affected·Apr 28, 2021
RecallFDA
Fresenius Medical Care Holdings, Inc.
DELFELX Peritoneal Dialysis Solution with 4.25% Dextrose, Low Magnesium, Low Calcium, 5000 mL, Fresenius Medical Care, Waltham, MA 02451,...
Drugs·49 affected·Apr 28, 2021
RecallFDA
Fresenius Medical Care Holdings, Inc.
DELFLEX Peritoneal Dialysis Solution with 4.25% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set, 2000 mL, packs ...
Drugs·4 affected·Apr 28, 2021
RecallFDA
Fresenius Medical Care Holdings, Inc.
DELFLEX Peritoneal Dialysis Solution with 2.5 % Dextrose, Low Magnesium, Low Calcium, packaged in a) 3000 mL 2 packs (NDC 49230-0209-23),...
Drugs·672 affected·Apr 28, 2021
RecallFDA
Fresenius Medical Care Holdings, Inc.
DELFLEX Peritoneal Dialysis Solution with 2.5% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set, packaged in a) 2...
Drugs·39 affected·Apr 28, 2021
RecallFDA
Fresenius Medical Care Holdings, Inc.
DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low Calcium, packaged in a) 3000 mL bags (NDC 49230-206-30) and ...
Drugs·285 affected·Apr 28, 2021
RecallFDA
Fresenius Medical Care Holdings, Inc.
DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set, 2000 mL Freseniu...
Drugs·5 affected·Apr 28, 2021
RecallFDA
Fresenius Medical Care Holdings, Inc.
DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL bags, 2-pack, Rx Only, Fresenius Medical Care NA, Waltham, MA 02451, NDC...
Drugs·25 affected·Apr 28, 2021
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate are each intended to be used as one component in the preparation...
Medical Devices·1 affected·Apr 28, 2021