Brand
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.
Optiflux F200NR High Flux Dialyzers; Product Number: 0500320N. Single Use acute or chronic hemanalysis treatment.
Medical Devices19,596 affectedFeb 4, 2014
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Optiflux F200NRe High Flux Dialyzers; Product Number: 0500320E. Single Use acute or chronic hemanalysis treatment.
Medical Devices317,796 affectedFeb 4, 2014
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Optiflux F160NRe High Flux Dialyzers; Product Number: 0500316E. Single Use acute or chronic hemanalysis treatment.
Medical Devices3,460,672 affectedFeb 4, 2014
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Optiflux B200 Flux Dialyzers; Product Number: 0500325E. Single Use acute or chronic hemanalysis treatment.
Medical Devices100,008 affectedFeb 4, 2014
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Optiflux F18Nre Flux Dialyzers; Product Number: 0500308E. Single Use acute or chronic hemanalysis treatment.
Medical Devices34,752 affectedFeb 4, 2014
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Fresenius Bicarbonate Jug Adapter to the 2008 Series Hemodialysis machine Part Number: 650103. The adapter is a socket that accepts t...
Medical Devices703 affectedDec 17, 2013
High RiskFDA
Fresenius Medical Care Holdings, Inc.
2008K@ Home Blood lines Combiset True Flow Series for Hemodialysis use Catalog Number: 03-2962-3. Intended for use as the extracorpor...
Medical Devices8,528 affectedAug 29, 2013
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Combiset Blood Line Hemodialysis use Catalog Number: 03-2622-3. Intended for use as the extracorporeal blood circuit during Hemodial...
Medical Devices508,029 affectedAug 29, 2013
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Fresenius Liberty Cycler Set Single Conn./Ext DL Product Number: 050-87216 Automated Peritoneal Dialysis System with integrated stay...
Medical Devices5,480 affectedJun 3, 2013
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Fresenius Service Replacement 0-Ring. Used in as a service part in 4 sub-assemblies manufactured and/or refurbished Fresenius hemodi...
Medical Devices725 affectedMay 24, 2013
RecallFDA
Fresenius Medical Care Holdings, Inc.
Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 3.0K 2.5 Ca 1Mg .16.5GAL Catalog Number: OFD3251-3B Pro...
Medical Devices14,240 affectedNov 26, 2012
RecallFDA
Fresenius Medical Care Holdings, Inc.
Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 3.0K 2,0 Ca 1.0Mg .16.5GAL Catalog Number: OFD3201-3B P...
Medical Devices670 affectedNov 26, 2012
RecallFDA
Fresenius Medical Care Holdings, Inc.
Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2,5 Ca 0.75Mg .16.5GAL Catalog Number: OFD2223-3B ...
Medical Devices2,493 affectedNov 26, 2012
RecallFDA
Fresenius Medical Care Holdings, Inc.
Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2.0 Ca 1Mg .16.5GAL Catalog Number: OFD2201-3B Pro...
Medical Devices17,782 affectedNov 26, 2012
CriticalFDA
Fresenius Medical Care Holdings, Inc.
Fresenius GranuFlo (powder) Acid Concentrate Product Codes: OFD1201-3B, OFD1251-3B, OFD2123-3B, OFD2201-3B, OFD2220-3B, OFD2223-3B,OFD2...
Medical Devices0 affectedMar 29, 2012
CriticalFDA
Fresenius Medical Care Holdings, Inc.
Fresenius NaturaLyte Liquid Acid Concentrate Product Codes: 08-0231-4, 08-1001-0, 08-1201-8, 08-1231-3, 08-1251-1, 08-1301-4, 08-2201-...
Medical Devices0 affectedMar 29, 2012