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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.
(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 chron...
Medical Devices·1 affected·Apr 28, 2021
High RiskFDA
Fresenius Medical Care Holdings, Inc.
The Drain Bag Set (tubings and flexible bags) is a passive, closed drainage system used as an optional receptacle during an APD treatment...
Medical Devices·10 affected·Apr 28, 2021
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate are each intended to be used as one component in the preparation of dial...
Medical Devices·1 affected·Apr 28, 2021
High RiskFDA
Fresenius Medical Care Holdings, Inc.
The Fresenius APD Luer-Lock Adapter, Catalog number 050-95018, is designed to connect a peritoneal dialysis bag equipped with a luer-lock...
Medical Devices·5 affected·Apr 28, 2021
High RiskFDA
Fresenius Medical Care Holdings, Inc.
026-20036A Liberty Drain Line, Luer Tap For patients with acute and chronic end stage renal disease going under PD in healthcare or home...
Medical Devices·6 affected·Apr 28, 2021
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Fresenius Medical Care NaturaLyte Liquid Acid concentrate-Liquid Acid Concentrate for Bicarbonate Hemodialyis Part Number: 08-3251-9
Medical Devices·2,280 affected·Dec 17, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Naturalyte Liquid Acid concentrate bottles, Product Code 08-2201-5 - Product Usage: used in conjunction with Fresenius Renal Technologies...
Medical Devices·2,246 affected·Nov 23, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Naturalyte Liquid Acid concentrate bottles, Product Code 08-2351-8 - Product Usage: used in conjunction with Fresenius Renal Technologies...
Medical Devices·123 affected·Nov 23, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Naturalyte Liquid Acid concentrate bottles, Product Code 08-4231-0 - Product Usage: used in conjunction with Fresenius Renal Technologies...
Medical Devices·912 affected·Nov 23, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Citrasate Liquid Acid concentrate bottles, Product Code 08-2251-CA - Product Usage: used in conjunction with Fresenius Renal Technologies...
Medical Devices·278 affected·Nov 23, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Naturalyte Liquid Acid concentrate drums, Product Code 13-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies S...
Medical Devices·224 affected·Nov 23, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Naturalyte Liquid Acid concentrate bottles, Product Code 08-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies...
Medical Devices·3,083 affected·Nov 23, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Citrasate Liquid Acid concentrate drums, Product Code 13-2251 -CA - Product Usage: used in conjunction with Fresenius Renal Technologies ...
Medical Devices·2 affected·Nov 23, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
NaturaLyte Liquid Acid concentrate drums, Model Number 13-1251-1 - Product Usage: used in conjunction with Fresenius Renal Technologies S...
Medical Devices·51 affected·Nov 7, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-4231-0 - Product Usage: used in conjunction with Fresenius Renal Technologies...
Medical Devices·1,726 affected·Nov 7, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
NaturaLyte Liquid Acid concentrate drums, Model Number 13-2201-5 - Product Usage: used in conjunction with Fresenius Renal Technologies S...
Medical Devices·27 affected·Nov 7, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2201-5 - Product Usage: used in conjunction with Fresenius Renal Technologies...
Medical Devices·5,765 affected·Nov 7, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2351-8 - Product Usage: used in conjunction with Fresenius Renal Technologies...
Medical Devices·577 affected·Nov 7, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
NaturaLyte Liquid Acid concentrate drums, Model Number 13-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies S...
Medical Devices·592 affected·Nov 7, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-1301-4 - Product Usage: used in conjunction with Fresenius Renal Technologies...
Medical Devices·527 affected·Nov 7, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Citrasate Liquid Acid concentrate bottles, Model Number 08-3251-CA - Product Usage: used in conjunction with Fresenius Renal Technologies...
Medical Devices·548 affected·Nov 7, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-1251-1 - Product Usage: used in conjunction with Fresenius Renal Technologies...
Medical Devices·3,665 affected·Nov 7, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3251-9 - Product Usage: used in conjunction with Fresenius Renal Technologies...
Medical Devices·19,646 affected·Nov 7, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2231-2 - Product Usage: used in conjunction with Fresenius Renal Technologies...
Medical Devices·180 affected·Nov 7, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2301-3 - Product Usage: used in conjunction with Fresenius Renal Technologies...
Medical Devices·8,272 affected·Nov 7, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3231-1 - Product Usage: used in conjunction with Fresenius Renal Technologies...
Medical Devices·1,006 affected·Nov 7, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3201-4 - Product Usage: used in conjunction with Fresenius Renal Technologies...
Medical Devices·819 affected·Nov 7, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Liberty Select Cycler Software Version 2.9.0 Model Number 180343 and RTLR180343
Medical Devices·9,907 affected·Sep 12, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
AquaBplus and AquaBplus B2 Water Purification System. For use with a hemodialysis system to remove organic and inorganic substances and ...
Medical Devices·15 affected·Sep 1, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Fresenius 2008T Hemodialysis Machine: Part Number Description 190573 2008T HEMODIAL YSIS SYS. OLC/DIASAFE PLUS; 190713 2008T HEMODIAL ...
Medical Devices·101,463 affected·Mar 12, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Fresenius 2008T BlueStar Hemodialysis Machine Part Number Description: 191124 2008T HD SYS. CDX BLUEST AR; 191126 2008T HD SYS. CDX ...
Medical Devices·15,342 affected·Mar 12, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Sodium Chloride 0.9% Injection, USP, 1000 mL bags, Rx only, Manufactured by: Fresenius Medical Care North America, Waltham, MA 02451
Injectable Drugs·32,592 affected·Mar 5, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Honeywell Pressure Transducer- Part Number: 370506-22. It is a component used in 2008T, Common Name: Hemodialysis Delivery System; 2008T ...
Medical Devices·3,561 affected·Jan 29, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Naturalyte Liquid Bicarbonate Concentrate 6.4 liter bottle A Dialysate Concentrate for Hemodialysis (liquid) Product Code: 08-4000-LB
Medical Devices·2,264,028 affected·Jul 16, 2015
High RiskFDA
Fresenius Medical Care Holdings, Inc.
NaturaLyte Liquid Bicarbonate Concentrate (Dialysate Concentrate for Hemodialysis (liquid), 6.4 Liter Bottle Catalog Number: 08-4000-LB ...
Medical Devices·1,856,619 affected·May 20, 2015
High RiskFDA
Fresenius Medical Care Holdings, Inc.
CRIT-LINE Blood Chamber- an accessory to the Crit line III- Monitors in real time blood parameters Model: CL10021021
Medical Devices·22,640,288 affected·Apr 27, 2015
High RiskFDA
Fresenius Medical Care Holdings, Inc.
2008 Series Hemodialysis Machines: 2008K with the following product code and description: 190305 2008K (w/ OLC); 190371 2008K System Std...
Medical Devices·133,751 affected·Feb 20, 2015
High RiskFDA
Fresenius Medical Care Holdings, Inc.
2008 Series Hemodialysis Machines: 2008K2 with the following product code and description: 190633 2008K2 HEMO SYSTEM, OPTIONAL MODULE; 1...
Medical Devices·133,751 affected·Feb 20, 2015
High RiskFDA
Fresenius Medical Care Holdings, Inc.
2008 Series Hemodialysis Machines: 2008T with the following product code and description: 190395 2008K at Home System - 1st Gen. -¿ Cana...
Medical Devices·133,751 affected·Feb 20, 2015
High RiskFDA
Fresenius Medical Care Holdings, Inc.
BD Vacutainer PST Tubes (GOLD TOP PST TUBE 3ml) Part Number: BD 367960 FMC part Number: 87-4544-4 Single use tube used to collect, s...
Diagnostic Devices·13 affected·Jun 23, 2014
High RiskFDA
Fresenius Medical Care Holdings, Inc.
BD Vacutainer Citrate Tubes (LIGHT BLUE TOP TUBE 2.7ML)Part number: BD 363083 Part Number: FMC 87-3083-8 Single use tube used to coll...
Diagnostic Devices·2 affected·Jun 23, 2014
High RiskFDA
Fresenius Medical Care Holdings, Inc.
BD Vacutainer EDTA Tubes (LAVENDER TOP TUBE 2.0ML) Part Number: BD 367841 Part Number: FMC 87-7841-7 Single use tube used to collec...
Diagnostic Devices·26 affected·Jun 23, 2014
High RiskFDA
Fresenius Medical Care Holdings, Inc.
BD Vacutainer Trace Element Tubes (ROYAL BLUE TOP TUBE 6.0ML) Part Number: 363083 Part Number: FMC 87-8380-1 Single use tube used to...
Diagnostic Devices·2 affected·Jun 23, 2014
High RiskFDA
Fresenius Medical Care Holdings, Inc.
BD Vacutainer SST Tubes (RED/GREY TOP SST TUBE 3.5ML) Part Number: BD 367981 Part Number: 87-7981-5 Single use tube used to collect,...
Diagnostic Devices·9 affected·Jun 23, 2014
High RiskFDA
Fresenius Medical Care Holdings, Inc.
BD Vacutainer Serum Tubes (RED TOP PLAIN TUBE 6.0 ML)Part Number: BD 367815 FMC Part Number: 87-7815-4 Single use tube used to coll...
Diagnostic Devices·3 affected·Jun 23, 2014
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Revision K Actuator Test Boards sold as replacement parts for use with Fresenius 2008-Series Hemodialysis Machines (2008K, 2008K2, 2008K...
Medical Devices·39 affected·Apr 25, 2014
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Fresenius 2008T Hemodialysis Machine with Revision K Actuator Test Boards and also sold as replacement parts for use with Fresenius 2008...
Medical Devices·79 affected·Apr 25, 2014
High RiskFDA
Fresenius Medical Care Holdings, Inc.
phosLo (calcium acetate) GelCaps, 667 mg, 200-count bottle, Rx only, Manufactured for Fresenius Medical Care North America, Waltham, MA 0...
Drugs·14,496 affected·Apr 14, 2014