FDA Device Recalls

Recalls / Firms / Fresenius Medical Care Holdings, Inc.

Fresenius Medical Care Holdings, Inc.

159 FDA device recalls on record.

DateClassProductReason
2025-10-25—5008X CAREsystem +CLiC +CDX;
2025-08-29—Optiflux High Flux E-beam Dialyzer Model Numbers: (1) 0500316E OPTIFLUX F160NRe 12/CS 1.5SA EBEAM,
2025-04-29—5008X HDF Hemodialysis Blood Tubing Set, 24 units per case, with the following models: a. 5008X Sta
2024-12-05—Dialyzer Optiflux 160NRe
2024-08-08—Blood Pressure Module BPM3 TM-2917B (Spare Part Numbers 191378 or 191389) with firmware version S005
2024-06-03—RTL190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F400
2024-06-03—190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F400154
2024-06-03—RTL190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev
2024-06-03—RTLR190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40
2024-06-03—RTL190904: 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F400
2024-06-03—191014: 2008K@HOME HD SYSTEM W/BIBAG (CANADA) - Blood Pump Rotor spare part, Model Number: F40015481
2024-06-03—190904 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F4001548
2024-06-03—190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
2024-05-16—US AquaA 900H-Typ USA-3 x 208v-Intended for the purification of water to be used for hemodialysis Vi
2024-04-17—2008T BlueStar Hemodialysis Machine, Model 191130 with Component: Blood Pump Rotor, Model Number: F4
2024-04-17—Blood Pump Rotor, Model Number: F40015481 Rev A
2024-04-17—2008T BlueStar Hemodialysis Machine, Model 191128 with Component: Blood Pump Rotor, Model Number: F4
2024-04-17—2008T BlueStar Hemodialysis Machine, Model 191124 with Component: Blood Pump Rotor, Model Number: F4
2024-04-17—2008T BlueStar Hemodialysis Machine, Model 191126 with Component: Blood Pump Rotor, Model Number: F4
2024-04-08—Novalung sensor box is a component of the Novalung Console (F30000162)-Indicated for long-term (> 6
2024-01-23—stay-safe /Luer Lock Adapter 4 in
2024-01-23—stay-safe /Luer Lock Catheter Ext. 18 in
2024-01-23—stay-safe /Luer Catheter Ext. 6 in
2024-01-23—stay-safe /Safe Lock Catheter Ext. 12 in
2024-01-23—stay-safe /Luer Lock Catheter Ext. 12 in
2023-10-24—Liberty Select Cycler, Model numbers RTLR180343 and RTLR180111
2023-10-10—Stay Safe Cap
2023-09-06—2008T HD SYS. W/O CDX BLUESTAR
2023-09-06—2008T Hemodialysis System without CDX
2023-09-06—2008T GEN 2 Bibag without CDX
2023-09-06—2008T HD SYS. CDX W/BIBAG BLUESTAR
2023-09-06—2008T Hemodialysis System w/Bibag
2023-09-06—2008T HD SYS. CDX BLUESTAR
2023-09-06—2008T Hemodialysis SYS, with CDX
2023-09-06—2008T HD SYS. W/O CDX W/BIBAG BLUESTAR
2023-08-08—3ML Syringe Luer Lock with needle 20GX1, Part Number 15-03ML-0, 100 per box, 24 boxes per case
2023-08-08—10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
2023-08-08—10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case
2022-10-04—NaturaLyte Liquid Acid concentrate, Part Number 08-0231-4, four (4) one-gallon bottles per bottle ca
2022-07-27—2008T and 2008TBluestar Hemodialysis Machines with CDX-Indicated for acute and chronic dialysis the
2022-06-21—AquaC UNO H [120V, 60Hz, 1700VA, US-Version- a reverse osmosis unit intended for use with hemodialys
2022-06-21—AquaC UNO H [120V, 60Hz, 1000VA, US-Version - a reverse osmosis unit intended for use with hemodialy
2022-06-16—AquaC UNO H [120V, 60Hz, 1700VA, Fresenius US-Version: 24-0970-1 Vivonic Part Number: G02000966-US
2022-06-16—AquaC UNO H [120V, 60Hz, 1000VA, Fresenius US-Version: 24-10VA-1 Vivonic Part Number: G02000970-
2022-06-01—NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal, Model No. 08-2301-3
2022-05-31—NATURALYTE Liquid Acid 3.0K 3.0Ca- indicated for use in patients undergoing extracorporeal bicarbona
2022-05-31—NATURALYTE Liquid Acid 2.0K 2.5Ca- indicated for use in patients undergoing extracorporeal bicarbona
2022-05-04—Optiflux 200NRe Dialyzer Finished Assy., Model no. 0500320E
2021-12-07—Novalung Sensor Box (F30000163) a component of Novalung Console (F30000162)- Indicated for long-term
2021-08-03—AquaBplus Water Purification System, Part Number 24-2000-0, AquaBplus 2500 - Typ USA (G02040108-US),
2021-04-28—(1) 08-4078-BB BIBAG 650 GRAMS/BAG 16 BAGS/CASE (2) 08-4080-BB BIBAG 900 grams/bag 12 bags/case F
2021-04-28—026-20036A Liberty Drain Line, Luer Tap For patients with acute and chronic end stage renal disease
2021-04-28—NaturaLyte Dry Bicarbonate Concentrate is composed of sodium bicarbonate powder and is used as one c
2021-04-28—The MTS Set is a single-use, sterile (EO), non-pyrogenic, optional accessory that provides additiona
2021-04-28—Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate are each intended to be used as one
2021-04-28—The Fresenius APD Luer-Lock Adapter, Catalog number 050-95018, is designed to connect a peritoneal d
2021-04-28—050-95012 Sterile Stay Safe Cap The Indications for Use/Intended Use for the Fresenius Sterile Stay
2021-04-28—Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate are each intended to be use
2021-04-28—The Drain Bag Set (tubings and flexible bags) is a passive, closed drainage system used as an option
2021-03-18—AquaBplus and AquaBplus B2 Water Purification System - Product Usage: Intended for use with a hemodi
2020-12-17—Fresenius Medical Care NaturaLyte Liquid Acid concentrate-Liquid Acid Concentrate for Bicarbonate He
2020-11-23—Naturalyte Liquid Acid concentrate bottles, Product Code 08-3251-9 - Product Usage: used in conjunct
2020-11-23—Naturalyte Liquid Acid concentrate bottles, Product Code 08-4231-0 - Product Usage: used in conjunct
2020-11-23—Naturalyte Liquid Acid concentrate bottles, Product Code 08-1251-1 - Product Usage: used in conjunct
2020-11-23—Naturalyte Liquid Acid concentrate drums, Product Code 13-3251-9 - Product Usage: used in conjunctio
2020-11-23—Naturalyte Liquid Acid concentrate drums, Product Code 13-2251-0 - Product Usage: used in conjunctio
2020-11-23—Naturalyte Liquid Acid concentrate bottles, Product Code 08-2351-8 - Product Usage: used in conjunct
2020-11-23—Naturalyte Liquid Acid concentrate bottles, Product Code 08-2201-5 - Product Usage: used in conjunct
2020-11-23—Citrasate Liquid Acid concentrate bottles, Product Code 08-2251-CA - Product Usage: used in conjunct
2020-11-23—Naturalyte Liquid Acid concentrate bottles, Product Code 08-2251-0 - Product Usage: used in conjunct
2020-11-23—Naturalyte Liquid Acid concentrate bottles, Product Code 08-2301-3 - Product Usage: used in conjunct
2020-11-23—Citrasate Liquid Acid concentrate drums, Product Code 13-2251 -CA - Product Usage: used in conjuncti
2020-11-07—NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3201-4 - Product Usage: used in conjunct
2020-11-07—Citrasate Liquid Acid concentrate drums, Model Number 13-3251-CA - Product Usage: used in conjunctio
2020-11-07—NaturaLyte Liquid Acid concentrate bottles, Model Number 08-1251-1 - Product Usage: used in conjunct
2020-11-07—NaturaLyte Liquid Acid concentrate drums, Model Number 13-2201-5 - Product Usage: used in conjunctio
2020-11-07—NaturaLyte Liquid Acid concentrate bottles, Model Number 08-1301-4 - Product Usage: used in conjunct
2020-11-07—NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3251-9 - Product Usage: used in conjunct
2020-11-07—NaturaLyte Liquid Acid concentrate drums, Model Number 13-1251-1 - Product Usage: used in conjunctio
2020-11-07—NaturaLyte Liquid Acid concentrate bottles, Model Number 08-4231-0 - Product Usage: used in conjunct
2020-11-07—NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2251-0 - Product Usage: used in conjunct
2020-11-07—NaturaLyte Liquid Acid concentrate drums, Model Number 13-2251-0 - Product Usage: used in conjunctio
2020-11-07—NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2201-5 - Product Usage: used in conjunct
2020-11-07—Citrasate Liquid Acid concentrate bottles, Model Number 08-3251-CA - Product Usage: used in conjunct
2020-11-07—NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2301-3 - Product Usage: used in conjunct
2020-11-07—NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2351-8 - Product Usage: used in conjunct
2020-11-07—NaturaLyte Liquid Acid concentrate drums, Model Number 13-3251-9 - Product Usage: used in conjunctio
2020-11-07—NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3231-1 - Product Usage: used in conjunct
2020-11-07—Citrasate Liquid Acid concentrate drums, Model Number 13-2251-CA - Product Usage: used in conjunctio
2020-11-07—NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3301-2 - Product Usage: used in conjunct
2020-11-07—NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2231-2 - Product Usage: used in conjunct
2020-09-12—Liberty Select Cycler Software Version 2.9.0 Model Number 180343 and RTLR180343
2020-09-01—AquaBplus and AquaBplus B2 Water Purification System. For use with a hemodialysis system to remove
2020-03-12—Fresenius 2008T Hemodialysis Machine: Part Number Description 190573 2008T HEMODIAL YSIS SYS. OLC/DI
2020-03-12—Fresenius 2008T BlueStar Hemodialysis Machine Part Number Description: 191124 2008T HD SYS. CDX BLU
2020-01-29—Honeywell Pressure Transducer- Part Number: 370506-22. It is a component used in 2008T, Common Name:
2015-07-16—Naturalyte Liquid Bicarbonate Concentrate 6.4 liter bottle A Dialysate Concentrate for Hemodialysis
2015-05-20—NaturaLyte Liquid Bicarbonate Concentrate (Dialysate Concentrate for Hemodialysis (liquid), 6.4 Lite
2015-04-27—CRIT-LINE Blood Chamber- an accessory to the Crit line III- Monitors in real time blood parameters M
2015-02-20—2008 Series Hemodialysis Machines: 2008T with the following product code and description: 190395 20
2015-02-20—2008 Series Hemodialysis Machines: 2008K2 with the following product code and description: 190633 2
2015-02-20—2008 Series Hemodialysis Machines: 2008Kathome - 190895 2008T GEN 2 BIBAG WITHOUT CDX; 190908 2008T
2015-02-20—2008 Series Hemodialysis Machines: 2008K with the following product code and description: 190305 20
2014-12-19—Fresenius Crit Line in a Clip (CLiC) with SW version 2.51 Model Number: CL10041001. A continuous re
2014-12-16—ASSY, POWER SUPPLY 130V 50HZ. This component is used with the following machines: 2008T Hemodialysi
2014-06-23—BD Vacutainer Citrate Tubes (LIGHT BLUE TOP TUBE 2.7ML)Part number: BD 363083 Part Number: FMC 87-30
2014-06-23—BD Vacutainer SST Tubes (RED/GREY TOP SST TUBE 3.5ML) Part Number: BD 367981 Part Number: 87-7981-5
2014-06-23—BD Vacutainer PST Tubes (GOLD TOP PST TUBE 3ml) Part Number: BD 367960 FMC part Number: 87-4544-4 S
2014-06-23—BD Vacutainer EDTA Tubes (LAVENDER TOP TUBE 2.0ML) Part Number: BD 367841 Part Number: FMC 87-7841-
2014-06-23—Fresenius Naturalyte Liquid Bicarbonate Concentrate Product Number: 08-4000-LB The concentrate is
2014-06-23—BD Vacutainer Trace Element Tubes (ROYAL BLUE TOP TUBE 6.0ML) Part Number: 363083 Part Number: FMC 8
2014-06-23—BD Vacutainer Serum Tubes (RED TOP PLAIN TUBE 6.0 ML)Part Number: BD 367815 FMC Part Number: 87-78
2014-05-01—NaturaLyte Liquid Bicarbonate Concentrate, 6.4 liter bottle to be used with a hemodialysis unit; Par
2014-04-25—Fresenius 2008T Hemodialysis Machine with Revision K Actuator Test Boards and also sold as replacem
2014-04-25—Revision K Actuator Test Boards sold as replacement parts for use with Fresenius 2008-Series Hemodi
2014-04-10—Naturalyte Liquid Bicarbonate Concentrate, 6.4 Liter Bottle Part Number: 08-4000-LB The concentrate
2014-02-04—Optiflux B200 Flux Dialyzers; Product Number: 0500325E. Single Use acute or chronic hemanalysis tre
2014-02-04—Optiflux F180NRe High Flux Dialyzers; Product Number: 0500318E. Single Use acute or chronic hemanal
2014-02-04—Optiflux F200NR High Flux Dialyzers; Product Number: 0500320N. Single Use acute or chronic hemanaly
2014-02-04—Optiflux F180NR High Flux Dialyzers; Product Number: 0500318N. Single Use acute or chronic hemanaly
2014-02-04—Optiflux F200NRe High Flux Dialyzers; Product Number: 0500320E. Single Use acute or chronic hemanal
2014-02-04—Optiflux F160NR High Flux Dialyzers; Product Number: 0500316N. Single Use acute or chronic hemanaly
2014-02-04—Optiflux F160NRe High Flux Dialyzers; Product Number: 0500316E. Single Use acute or chronic hemanal
2014-02-04—Optiflux F18Nre Flux Dialyzers; Product Number: 0500308E. Single Use acute or chronic hemanalysis t
2014-02-04—Optiflux F200A High Flux Dialyzers; Product Number: 0500320A. Single Use acute or chronic hemanalys
2013-12-17—Fresenius Bicarbonate Jug Adapter to the 2008 Series Hemodialysis machine Part Number: 650103. The
2013-11-12—Fresenius 2008 Series Hemodialysis Machines: Models: 2008H, 2008K, 2008K2, 2008k@Home, 2008T The 20
2013-10-14—Fresenius Liberty Cycler Part Number: RTLR180111 Product Usage: The Liberty cycler is a portable de
2013-08-29—Combiset Blood Line Hemodialysis use Catalog Number: 03-2622-3. Intended for use as the extracorpo
2013-08-29—2008K@ Home Blood lines Combiset True Flow Series for Hemodialysis use Catalog Number: 03-2962-3. I
2013-08-29—Combiset Blood Line with BVM for Hemodialysis use Catalog Number: 03-2965-9. Intended for use as th
2013-06-03—Fresenius Liberty Cycler Set Single Conn./Ext DL Product Number: 050-87216 Automated Peritoneal Di
2013-05-24—Fresenius Service Replacement 0-Ring. Used in as a service part in 4 sub-assemblies manufactured
2012-11-26—Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 3.0K 2,5 Ca 0.75Mg .16
2012-11-26—Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2,5 Ca 0.75Mg .16
2012-11-26—Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 3.0K 2,0 Ca 1.0Mg .16.
2012-11-26—Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 3.0K 2.5 Ca 1Mg .16.5G
2012-11-26—Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2.25 Ca 1Mg .16.5
2012-11-26—Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 1.0K 2.0 Ca 1Mg .16.5G
2012-11-26—Fresenius GranuFlo Dry Acid Concentrate For Bicarbonate Dialysis 2.0 K 2.5 Ca 1 Mg 16.5 GAL Catalog
2012-11-26—Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2.0 Ca 1Mg .16.5G
2012-11-26—Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2,5 Ca 0.75 Mg .
2012-10-12—Fresenius Liberty Cycler Set Single Conn. Ext. DL. Part Number: 050-87216. Acute and chronic perito
2012-03-30—Fresenius Liberty Cycler Software, User Manuals, and Handi-Guides for acute and chronic peritoneal d
2012-03-29—Fresenius NaturaLyte Liquid Acid Concentrate Product Codes: 08-0231-4, 08-1001-0, 08-1201-8, 08-123
2012-03-29—Fresenius GranuFlo (powder) Acid Concentrate Product Codes: OFD1201-3B, OFD1251-3B, OFD2123-3B, OFD2
2012-03-16—Fresenius Medical Naturalyte Acid Concentrate for bicarbonate Dialysis 45x , 55 gallons (208.2 Liter
2012-03-06—Fresenius Optiflux F160NRe Hemodialyzer Catalog number: 0500316E Intended for patients with acute o
2011-12-27—Fresenius Optiflux F250NRe Hemodialyzer, , intended for single use in acute and chronic hemodialysis
2011-08-11—CombiSet True Flow" 2008K@home Bloodlines Fresenius Medical Care. Used for transferring blood durin
2011-05-04—Fresenius 2008K@home The Fresenius 2008K@home is indicated for acute and chronic dialysis therapy i
2011-03-23—Naturalyte@ Sodium Bicarbonate Liquid Concentrate, Dialysate Concentrate for Hemodialysis Liquid Par
2011-02-16—Fresenius Optiflux F250NRe Hemodialyzer, Single Use, Catalog Number: 0500325E, Advanced Fresenius P
2011-01-19—Fresenius 2008T Hemodialysis Machine Part Number 190573, 2008T Hemodialysis System, OLCIDIASAFE PLUS
2010-11-19—Fresenius Medical CombiSet BVM Hemodialysis Blood Tubing Set P/N: 03-2695-9
2010-11-19—Fresenius Medical CombiSet BVM Hemodialysis Blood Tubing Set P/N: 03-2795-7
2010-09-03—LIBERTY Automated Peritoneal Dialysis System lntegrated Cycler Set with single stay safe patient con
2010-09-03—LIBERTY Automated Peritoneal Dialysis System Line Cycler Set with stay safe connectors (Dual Patient
2010-09-03—LIBERTY Automated Peritoneal Dialysis System Line Cycler Set with stay safe connectors (Single Patie