Fresenius Medical Care Holdings, Inc.
113 recalls on record · Latest: Dec 24, 2025
FDA Devices Moderate Dec 24, 2025
5008X CAREsystem +CLiC +CDX;
FDA Drug Moderate Jul 2, 2025
0.9% Sodium Chloride Injection, USP, Flexible Plastic Container, Rx Only Fresenius Medical Care North America, Waltham, MA 02451, 1-800-323-5188, NDC…
FDA Drug Moderate Jul 24, 2024
DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW CALCIUM 4.25% DEXTROSE and attached stay "safe Exchange Set, 2500mL (Approx. 50 mL exce…
FDA Devices Moderate Jul 17, 2024
RTL190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
FDA Devices Moderate Jul 17, 2024
RTLR190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
FDA Devices Moderate Jul 17, 2024
190904 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
FDA Devices Moderate Jul 17, 2024
190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
FDA Devices Moderate Jul 17, 2024
190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
FDA Devices Moderate Jul 17, 2024
RTL190904: 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
FDA Devices Moderate May 29, 2024
Blood Pump Rotor, Model Number: F40015481 Rev A
FDA Devices Moderate May 29, 2024
2008T BlueStar Hemodialysis Machine, Model 191126 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
FDA Devices Moderate May 29, 2024
2008T BlueStar Hemodialysis Machine, Model 191128 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
FDA Devices Moderate May 29, 2024
2008T BlueStar Hemodialysis Machine, Model 191124 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
FDA Devices Moderate May 29, 2024
2008T BlueStar Hemodialysis Machine, Model 191130 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A
FDA Devices Moderate May 22, 2024
Novalung sensor box is a component of the Novalung Console (F30000162)-Indicated for long-term (> 6 hours) respiratory/ cardiopulmonary support that …
FDA Devices Critical Apr 3, 2024
stay-safe /Luer Lock Adapter 4 in
FDA Devices Critical Apr 3, 2024
stay-safe /Luer Lock Catheter Ext. 18 in
FDA Devices Critical Apr 3, 2024
stay-safe /Luer Catheter Ext. 6 in
FDA Devices Critical Apr 3, 2024
stay-safe /Luer Lock Catheter Ext. 12 in
FDA Drug Moderate Jan 10, 2024
DELFLEX Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose, packaged in 6000mL bags, Rx only, Fresenius Medical Care NA Waltham, MA 0245…
FDA Devices Moderate Dec 13, 2023
Stay Safe Cap
FDA Devices Critical Oct 18, 2023
2008T HD SYS. W/O CDX BLUESTAR
FDA Devices Critical Oct 18, 2023
2008T Hemodialysis SYS, with CDX
FDA Devices Critical Oct 18, 2023
3ML Syringe Luer Lock with needle 20GX1, Part Number 15-03ML-0, 100 per box, 24 boxes per case
FDA Devices Critical Oct 18, 2023
10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case
FDA Devices Critical Oct 18, 2023
2008T HD SYS. W/O CDX W/BIBAG BLUESTAR
FDA Drug Moderate Jun 7, 2023
Sodium Chloride 0.9% Injection, USP, 1000 mL bags, 12 bags per carton, Rx only, Fresenius Medical Care North America, Waltham, MA 02451, NDC # 49230-…
FDA Devices Moderate Dec 28, 2022
2008T and 2008TBluestar Hemodialysis Machines with CDX-Indicated for acute and chronic dialysis therapy in a healthcare facility Models: (1) 19071…
FDA Drug Moderate Dec 14, 2022
0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs, 1000mL Bag, 12 PK, Rx Only, …
FDA Devices Moderate Nov 16, 2022
NaturaLyte Liquid Acid concentrate, Part Number 08-0231-4, four (4) one-gallon bottles per bottle case. For dialysis.
FDA Drug Moderate Oct 26, 2022
0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs, 1000mL Bag, 12 PK, Rx Only, …
FDA Devices Moderate Sep 28, 2022
AquaC UNO H [120V, 60Hz, 1000VA, US-Version - a reverse osmosis unit intended for use with hemodialysis systems. Fresenius Part Number: 24-10VA-1…
FDA Devices Moderate Aug 3, 2022
AquaC UNO H [120V, 60Hz, 1700VA, Fresenius US-Version: 24-0970-1 Vivonic Part Number: G02000966-US
FDA Devices Moderate Aug 3, 2022
AquaC UNO H [120V, 60Hz, 1000VA, Fresenius US-Version: 24-10VA-1 Vivonic Part Number: G02000970-US
FDA Devices Moderate Jul 20, 2022
NATURALYTE Liquid Acid 3.0K 3.0Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failu…
FDA Devices Moderate Jul 20, 2022
AquaBplus Water Purification System, Part Number 24-2000-0, AquaBplus 2500 - Typ USA (G02040108-US), AquaBplus 2000 - Typ USA (G02040114-US), AquaBpl…
FDA Devices Moderate Jul 20, 2022
NATURALYTE Liquid Acid 2.0K 2.5Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failu…
FDA Devices Moderate Jul 6, 2022
Optiflux 200NRe Dialyzer Finished Assy., Model no. 0500320E
FDA Devices Moderate Jul 28, 2021
Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate are each intended to be used as one component in the preparation of dialysat…
FDA Devices Moderate Jul 28, 2021
(1) 08-4078-BB BIBAG 650 GRAMS/BAG 16 BAGS/CASE (2) 08-4080-BB BIBAG 900 grams/bag 12 bags/case For patients with acute and chronic end stage…
FDA Devices Moderate Jul 28, 2021
The Drain Bag Set (tubings and flexible bags) is a passive, closed drainage system used as an optional receptacle during an APD treatment. The Drain …
FDA Devices Moderate Jul 28, 2021
Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate are each intended to be used as one component in the preparation of dialysate in a 3…
FDA Devices Moderate Jul 28, 2021
The Fresenius APD Luer-Lock Adapter, Catalog number 050-95018, is designed to connect a peritoneal dialysis bag equipped with a luer-lock connector t…
FDA Devices Moderate Jul 28, 2021
026-20036A Liberty Drain Line, Luer Tap For patients with acute and chronic end stage renal disease going under PD in healthcare or home setting
FDA Drug Moderate Jun 16, 2021
Sodium Chloride 0.9%, USP, 1000 mL, Mfg by: Fresenius Medical Care North America, Waltham, MA 02451, NDC 46163-0300-10
FDA Drug Low Jun 16, 2021
DELFELX Peritoneal Dialysis Solution with 4.25% Dextrose, Low Magnesium, Low Calcium, 5000 mL, Fresenius Medical Care, Waltham, MA 02451, NDC 49230-…
FDA Drug Low Jun 16, 2021
DELFLEX Peritoneal Dialysis Solution with 4.25% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set, 2000 mL, packs of 5, Rx onl…
FDA Drug Low Jun 16, 2021
DELFLEX Peritoneal Dialysis Solution with 2.5 % Dextrose, Low Magnesium, Low Calcium, packaged in a) 3000 mL 2 packs (NDC 49230-0209-23), b) 3000 mL …
FDA Drug Low Jun 16, 2021
DELFLEX Peritoneal Dialysis Solution with 2.5% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set, packaged in a) 2500 mL (NDC…
FDA Drug Low Jun 16, 2021