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
Sodium Chloride 0.9% Injection, USP, 1000 mL bags, Rx only, Manufactured by: Fresenius Medical Care North Amer...
Mar 25, 2020
· Drug
Class II
Terminated
Fresenius 2008T BlueStar Hemodialysis Machine
Part Number Description:
191124 2008T HD SYS. CDX BLUEST AR;
19...
Mar 12, 2020
· Device
Active
Fresenius 2008T Hemodialysis Machine:
Part Number Description
190573 2008T HEMODIAL YSIS SYS. OLC/DIASAFE PLUS...
Mar 12, 2020
· Device
Active
Honeywell Pressure Transducer- Part Number: 370506-22. It is a component used in 2008T, Common Name: Hemodialy...
Jan 29, 2020
· Device
Terminated
Naturalyte Liquid Bicarbonate Concentrate 6.4 liter bottle
A Dialysate Concentrate for Hemodialysis (liquid)
P...
Aug 12, 2015
· Device
Active
NaturaLyte Liquid Bicarbonate Concentrate (Dialysate Concentrate for Hemodialysis (liquid), 6.4 Liter Bottle
C...
Jun 22, 2015
· Device
Active
CRIT-LINE Blood Chamber- an accessory to the Crit line III- Monitors in real time blood parameters
Model: CL10...
Jun 5, 2015
· Device
Terminated
2008 Series Hemodialysis Machines: 2008K with the following product code and description: 190305 2008K (w/ OL...
Apr 29, 2015
· Device
Terminated
2008 Series Hemodialysis Machines: 2008T with the following product code and description: 190395 2008K at Hom...
Apr 29, 2015
· Device
Terminated
2008 Series Hemodialysis Machines: 2008K2 with the following product code and description: 190633 2008K2 HEMO...
Apr 29, 2015
· Device
Terminated
2008 Series Hemodialysis Machines: 2008Kathome - 190895 2008T GEN 2 BIBAG WITHOUT CDX; 190908 2008T HD SYSTEM...
Apr 29, 2015
· Device
Terminated
Fresenius Crit Line in a Clip (CLiC) with SW version 2.51 Model Number: CL10041001. A continuous real-time mo...
Feb 3, 2015
· Device
Terminated
ASSY, POWER SUPPLY 130V 50HZ. This component is used with the following machines: 2008T Hemodialysis Machine,...
Jan 27, 2015
· Device
Terminated
Fresenius Naturalyte Liquid Bicarbonate Concentrate
Product Number: 08-4000-LB
The concentrate is formulated...
Sep 23, 2014
· Device
Terminated
BD Vacutainer Citrate Tubes (LIGHT BLUE TOP TUBE 2.7ML)Part number: BD 363083
Part Number: FMC 87-3083-8
Sing...
Sep 12, 2014
· Device
Terminated
BD Vacutainer Serum Tubes (RED TOP PLAIN TUBE 6.0 ML)Part Number: BD 367815
FMC Part Number: 87-7815-4
Sing...
Sep 12, 2014
· Device
Terminated
BD Vacutainer PST Tubes (GOLD TOP PST TUBE 3ml)
Part Number: BD 367960
FMC part Number: 87-4544-4
Single use...
Sep 12, 2014
· Device
Terminated
BD Vacutainer SST Tubes (RED/GREY TOP SST TUBE 3.5ML)
Part Number: BD 367981
Part Number: 87-7981-5
Single us...
Sep 12, 2014
· Device
Terminated
BD Vacutainer Trace Element Tubes (ROYAL BLUE TOP TUBE 6.0ML)
Part Number: 363083
Part Number: FMC 87-8380-1...
Sep 12, 2014
· Device
Terminated
BD Vacutainer EDTA Tubes (LAVENDER TOP TUBE 2.0ML)
Part Number: BD 367841
Part Number: FMC 87-7841-7
Single...
Sep 12, 2014
· Device
Terminated
NaturaLyte Liquid Bicarbonate Concentrate, 6.4 liter bottle to be used with a hemodialysis unit; Part Number:...
Jun 9, 2014
· Device
Terminated
phosLo (calcium acetate) GelCaps, 667 mg, 200-count bottle, Rx only, Manufactured for Fresenius Medical Care N...
May 28, 2014
· Drug
Class II
Terminated
Naturalyte Liquid Bicarbonate Concentrate, 6.4 Liter Bottle
Part Number: 08-4000-LB
The concentrate is formul...
May 22, 2014
· Device
Active
Fresenius 2008T Hemodialysis Machine with Revision K Actuator Test Boards and also sold as replacement parts...
May 13, 2014
· Device
Terminated
Revision K Actuator Test Boards sold as replacement parts for use with Fresenius 2008-Series Hemodialysis Mac...
May 13, 2014
· Device
Terminated
Optiflux F200NR High Flux Dialyzers; Product Number: 0500320N.
Single Use acute or chronic hemanalysis treatm...
Feb 26, 2014
· Device
Terminated
Optiflux F180NRe High Flux Dialyzers; Product Number: 0500318E.
Single Use acute or chronic hemanalysis treat...
Feb 26, 2014
· Device
Terminated
Optiflux F180NR High Flux Dialyzers; Product Number: 0500318N.
Single Use acute or chronic hemanalysis treatm...
Feb 26, 2014
· Device
Terminated
Optiflux F160NR High Flux Dialyzers; Product Number: 0500316N.
Single Use acute or chronic hemanalysis treatm...
Feb 26, 2014
· Device
Terminated
Optiflux F18Nre Flux Dialyzers; Product Number: 0500308E.
Single Use acute or chronic hemanalysis treatment.
Feb 26, 2014
· Device
Terminated
Optiflux F200NRe High Flux Dialyzers; Product Number: 0500320E.
Single Use acute or chronic hemanalysis treat...
Feb 26, 2014
· Device
Terminated
Optiflux F160NRe High Flux Dialyzers; Product Number: 0500316E.
Single Use acute or chronic hemanalysis treat...
Feb 26, 2014
· Device
Terminated
Optiflux F200A High Flux Dialyzers; Product Number: 0500320A.
Single Use acute or chronic hemanalysis treatme...
Feb 26, 2014
· Device
Terminated
Optiflux B200 Flux Dialyzers; Product Number: 0500325E.
Single Use acute or chronic hemanalysis treatment.
Feb 26, 2014
· Device
Terminated
Fresenius Bicarbonate Jug Adapter to the 2008 Series Hemodialysis machine
Part Number: 650103.
The adapter is...
Feb 3, 2014
· Device
Terminated
Fresenius 2008 Series Hemodialysis Machines:
Models: 2008H, 2008K, 2008K2, 2008k@Home, 2008T
The 2008H Hemodi...
Jan 6, 2014
· Device
Terminated
Combiset Blood Line Hemodialysis use
Catalog Number: 03-2622-3.
Intended for use as the extracorporeal blood...
Nov 8, 2013
· Device
Terminated
Combiset Blood Line with BVM for Hemodialysis use
Catalog Number: 03-2965-9.
Intended for use as the extracor...
Nov 8, 2013
· Device
Terminated
2008K@ Home Blood lines Combiset True Flow Series for Hemodialysis use
Catalog Number: 03-2962-3.
Intended fo...
Nov 8, 2013
· Device
Terminated
Fresenius Liberty Cycler
Part Number: RTLR180111
Product Usage:
The Liberty cycler is a portable device desig...
Nov 5, 2013
· Device
Terminated
Fresenius Service Replacement 0-Ring.
Used in as a service part in 4 sub-assemblies manufactured and/or ref...
Jul 11, 2013
· Device
Terminated
Fresenius Liberty Cycler Set Single Conn./Ext DL
Product Number: 050-87216
Automated Peritoneal Dialysis Sys...
Jul 10, 2013
· Device
Terminated
Fresenius Liberty Cycler Set Single Conn. Ext. DL. Part Number: 050-87216.
Acute and chronic peritoneal dialy...
Feb 11, 2013
· Device
Terminated
Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 3.0K 2.5 Ca 1Mg .16.5GAL
Catalog...
Jan 17, 2013
· Device
Terminated
Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2,5 Ca 0.75Mg .16.5GAL
Cata...
Jan 17, 2013
· Device
Terminated
Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 3.0K 2,0 Ca 1.0Mg .16.5GAL
Catal...
Jan 17, 2013
· Device
Terminated
Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 1.0K 2.0 Ca 1Mg .16.5GAL
Catalog...
Jan 17, 2013
· Device
Terminated
Fresenius GranuFlo Dry Acid Concentrate For Bicarbonate Dialysis 2.0 K 2.5 Ca 1 Mg 16.5 GAL
Catalog Number: OF...
Jan 17, 2013
· Device
Terminated
Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 3.0K 2,5 Ca 0.75Mg .16.5GAL
Cata...
Jan 17, 2013
· Device
Terminated
Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2.0 Ca 1Mg .16.5GAL
Catalog...
Jan 17, 2013
· Device
Terminated