The Recall Desk

Manufacturer

Fresenius Medical Care Holdings, Inc.

166 recalls in our database name Fresenius Medical Care Holdings, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
166
Critical
1
Severe
32
Most recent
2026-07-15

Of the 166 recalls from Fresenius Medical Care Holdings, Inc. we have scored against our rubric, 1 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 32 (19%) are Severe.

Which agencies issued them

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

101–125 of 166

  • HighFDA (Devices)·Z-0839-2021·2021-01-20

    Fresenius Naturalyte Liquid Acid concentrate drums recalled for conductivity deviation

    Fresenius Medical Care is recalling 224 drums of Naturalyte Liquid Acid concentrate due to deviations in conductivity and calcium concentration.

    Product
    Naturalyte Liquid Acid concentrate drums, Product Code 13-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0841-2021·2021-01-20

    Fresenius Citrasate Liquid Acid concentrate drums recalled for conductivity deviation

    Fresenius Medical Care is recalling two drums of Citrasate Liquid Acid concentrate due to deviations in sodium conductivity and calcium concentration.

    Product
    Citrasate Liquid Acid concentrate drums, Product Code 13-2251 -CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0811-2021·2021-01-20

    Fresenius NaturaLyte Liquid Acid Concentrate Recall for Low Sodium Levels

    Fresenius Medical Care is recalling NaturaLyte Liquid Acid concentrate bottles because sodium and/or calcium levels were below manufacturing specifications.

    Product
    NaturaLyte Liquid Acid concentrate bottles, Model Number 08-1251-1 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0822-2021·2021-01-20

    Fresenius NaturaLyte Liquid Acid Concentrate Recall for Low Sodium Levels

    Fresenius Medical Care is recalling NaturaLyte Liquid Acid concentrate bottles because sodium and/or calcium levels were below manufacturing specifications.

    Product
    NaturaLyte Liquid Acid concentrate bottles, Model Number 08-4231-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0812-2021·2021-01-20

    Fresenius NaturaLyte Liquid Acid Concentrate Recall for Low Sodium Levels

    Fresenius Medical Care is recalling NaturaLyte Liquid Acid concentrate bottles because sodium and/or calcium levels were below manufacturing specifications.

    Product
    NaturaLyte Liquid Acid concentrate bottles, Model Number 08-1301-4 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0825-2021·2021-01-20

    Fresenius NaturaLyte Liquid Acid concentrate drums recalled for low sodium levels

    Fresenius Medical Care is recalling NaturaLyte Liquid Acid concentrate drums because sodium and/or calcium levels were below manufacturing specifications.

    Product
    NaturaLyte Liquid Acid concentrate drums, Model Number 13-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0834-2021·2021-01-20

    Fresenius Citrasate Liquid Acid Concentrate Recalled for Conductivity Deviation

    Fresenius Medical Care is recalling Citrasate Liquid Acid concentrate bottles due to conductivity deviations and low calcium levels.

    Product
    Citrasate Liquid Acid concentrate bottles, Product Code 08-2251-CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0836-2021·2021-01-20

    Fresenius Naturalyte Liquid Acid Concentrate Recall for Conductivity Deviation

    Fresenius Medical Care is recalling 123 bottles of Naturalyte Liquid Acid concentrate due to conductivity deviations and low calcium levels.

    Product
    Naturalyte Liquid Acid concentrate bottles, Product Code 08-2351-8 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0814-2021·2021-01-20

    Fresenius NaturaLyte Liquid Acid Concentrate Recall for Low Sodium Levels

    Fresenius Medical Care is recalling NaturaLyte Liquid Acid concentrate bottles because sodium and/or calcium levels were below manufacturing specifications.

    Product
    NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2231-2 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0824-2021·2021-01-20

    Fresenius NaturaLyte Liquid Acid Concentrate Drums Recalled for Low Levels

    Fresenius Medical Care is recalling 27 drums of NaturaLyte Liquid Acid concentrate because sodium and/or calcium levels were below manufacturing specifications.

    Product
    NaturaLyte Liquid Acid concentrate drums, Model Number 13-2201-5 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0439-2021·2020-11-18

    Fresenius Liberty Select Cycler Software Recall for Inadequate Dialysis Risk

    Fresenius Medical Care is recalling Liberty Select Cycler devices with software version 2.9.0 because a software error may cause the device to fail to recognize extra fluid, potentially leading to inadequate dialysis.

    Product
    Liberty Select Cycler Software Version 2.9.0 Model Number 180343 and RTLR180343
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0098-2021·2020-10-21

    Fresenius AquaBplus Water Purification Systems Recalled for Electrical Safety Defect

    Fresenius Medical Care is recalling 15 AquaBplus water purification systems due to incorrectly crimped connectors that could cause electrical shock.

    Product
    AquaBplus and AquaBplus B2 Water Purification System. For use with a hemodialysis system to remove organic and inorganic substances and microbial contaminants from the water used for hemodialysis or related therapies. AquaBplus 1500 - Typ USA - 3 x 208V / 60Hz -Fresenius Part
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1749-2020·2020-04-29

    Fresenius 2008T BlueStar Hemodialysis Machines Recalled for USB False Alarm

    Fresenius Medical Care is recalling 15,342 hemodialysis machines because a false alarm may appear when a USB device is connected.

    Product
    Fresenius 2008T BlueStar Hemodialysis Machine Part Number Description: 191124 2008T HD SYS. CDX BLUEST AR; 191126 2008T HD SYS. CDX W/BIBAG BLUEST AR; 191128 2008T HD SYS. W/O CDX BLUEST AR; 191130 2008T HD SYS. W/O CDX W/BIBAG BLUEST AR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1748-2020·2020-04-29

    Fresenius 2008T Hemodialysis Machines Recalled for False USB Alarm

    Fresenius Medical Care is recalling 2008T hemodialysis machines because they may display a false 'Remove USB Device 2' alarm when no USB device is connected.

    Product
    Fresenius 2008T Hemodialysis Machine: Part Number Description 190573 2008T HEMODIAL YSIS SYS. OLC/DIASAFE PLUS; 190713 2008T HEMODIAL YSIS SYS., with CDX; 190766 2008T HEMODIAL YSIS SYSTEM W/BIBAG; 190858 2008T HEMODIAL YSIS SYSTEM WITHOUT CDX; 190895 2008T GEN 2 BIBAG WITH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1529-2020·2020-04-01

    Fresenius Medical Care Recalls Honeywell Pressure Transducers for Hemodialysis Systems

    Fresenius Medical Care is recalling 3,561 Honeywell pressure transducers used in hemodialysis delivery systems due to lower long-term reliability.

    Product
    Honeywell Pressure Transducer- Part Number: 370506-22. It is a component used in 2008T, Common Name: Hemodialysis Delivery System; 2008T HD SYS. BLUE STAR; 2008K2, Common Name: Hemodialysis Delivery Equipment; 2008K@home, Common Name: Hemodialysis Delivery System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1064-2020·2020-03-25

    Fresenius Recalls Sodium Chloride Injection Bags Due to Sterilization Issue

    Fresenius Medical Care is recalling 32,592 bags of Sodium Chloride 0.9% Injection because chemical indicators were not positioned properly during sterilization.

    Product
    Sodium Chloride 0.9% Injection, USP, 1000 mL bags, Rx only, Manufactured by: Fresenius Medical Care North America, Waltham, MA 02451
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2373-2015·2015-08-19

    Fresenius Medical Care Recalls Naturalyte Liquid Bicarbonate Concentrate

    Fresenius Medical Care is recalling Naturalyte Liquid Bicarbonate Concentrate due to potential bacterial contamination. The recall covers 2,264,028 units distributed nationwide.

    Product
    Naturalyte Liquid Bicarbonate Concentrate 6.4 liter bottle A Dialysate Concentrate for Hemodialysis (liquid) Product Code: 08-4000-LB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1827-2015·2015-07-01

    Fresenius NaturaLyte Liquid Bicarbonate Concentrate Recalled for Bacterial Contamination

    Fresenius Medical Care is recalling NaturaLyte Liquid Bicarbonate Concentrate due to bacterial contamination. The product is used in hemodialysis machines.

    Product
    NaturaLyte Liquid Bicarbonate Concentrate (Dialysate Concentrate for Hemodialysis (liquid), 6.4 Liter Bottle Catalog Number: 08-4000-LB This concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1716-2015·2015-06-17

    Fresenius CRIT-LINE Blood Chamber Recalled for Connection Leaks

    Fresenius Medical Care is recalling CRIT-LINE Blood Chambers because the connection may leak during use.

    Product
    CRIT-LINE Blood Chamber- an accessory to the Crit line III- Monitors in real time blood parameters Model: CL10021021
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1552-2015·2015-05-06

    Fresenius 2008K2 Hemodialysis Machines Recalled for Acetate Display Error

    Fresenius Medical Care is recalling 2008K2 hemodialysis machines because the GranuFlo acetate value is incorrectly displayed as 4mEq/l instead of 8mEq/l on the Select Concentrate screen.

    Product
    2008 Series Hemodialysis Machines: 2008K2 with the following product code and description: 190633 2008K2 HEMO SYSTEM, OPTIONAL MODULE; 190618 2008K2 HEMODIALYSIS SYS OLC/DP, SPANISH; 190610 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS; 190630 2008K2 MACHINE, SHORT CAB, OLC/DP, HP; 1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1551-2015·2015-05-06

    Fresenius 2008K Hemodialysis Machines Recalled for Acetate Display Error

    Fresenius Medical Care is recalling 2008K hemodialysis machines because the GranuFlo acetate value is incorrectly displayed as 4mEq/l instead of 8mEq/l on the Select Concentrate screen.

    Product
    2008 Series Hemodialysis Machines: 2008K with the following product code and description: 190305 2008K (w/ OLC); 190371 2008K System Std (w/OLC and Diasafe Plus); 190300 2008K System Std (w/OLC and Diasafe); 190336 2008K System w/ Fifth Module Holder; 190517 2008K System w/ OLC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1549-2015·2015-05-06

    Fresenius 2008 Hemodialysis Machines Recalled for Acetate Display Error

    Fresenius Medical Care is recalling 2008 Series Hemodialysis Machines because the Acetate value for GranuFlo is displayed incorrectly on the Select Concentrate screen.

    Product
    2008 Series Hemodialysis Machines: 2008Kathome - 190895 2008T GEN 2 BIBAG WITHOUT CDX; 190908 2008T HD SYSTEM WITH CDX, CANADA; 190713 2008T HEMODIALYSIS SYS., with CDX; 190766 2008T HEMODIALYSIS SYSTEM W/BIBAG; 190858 2008T HEMODIALYSIS SYSTEM WITHOUT CDX The Fresenius 2008K
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1550-2015·2015-05-06

    Fresenius 2008T Hemodialysis Machines Recalled for Acetate Display Error

    Fresenius Medical Care is recalling 2008T hemodialysis machines because the Select Concentrate screen incorrectly displays the GranuFlo acetate value as 4mEq/l instead of 8mEq/l.

    Product
    2008 Series Hemodialysis Machines: 2008T with the following product code and description: 190395 2008K at Home System - 1st Gen. -¿ Canada; 190828 2008K at Home System - 2nd Gen - U.S.; 190904 2008K at Home System w/ Bibag; 190828 2008KatHOME HEMODIALYSIS SYSTEM; 190395 2008
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1047-2015·2015-02-11

    Fresenius Crit Line in a Clip Monitor Recalled for Display Misinterpretation

    Fresenius Medical Care is recalling 35 Crit Line in a Clip monitors due to a potential for misinterpretation of the Blood Volume slope graphic display.

    Product
    Fresenius Crit Line in a Clip (CLiC) with SW version 2.51 Model Number: CL10041001. A continuous real-time monitor for non-invasive hematocrit, oxygen saturation and percent change in blood volume calculation during hemodialysis treatment.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1015-2015·2015-02-04

    Fresenius Medical Care Recalls Unqualified Hemodialysis Power Supply Assemblies

    Fresenius Medical Care is recalling 10 unqualified power supply assemblies for specific hemodialysis machines. The components were distributed in Oklahoma and Florida.

    Product
    ASSY, POWER SUPPLY 130V 50HZ. This component is used with the following machines: 2008T Hemodialysis Machine, 2008K Hemodialysis Delivery Equipment, 2008 K2 Hemodialysis Delivery Equipment 2008K@home Hemodialysis Delivery System
    Category
    Medical Device
    Distribution
    2 states

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Fresenius Medical Care

German medical supply company

Country
Germany
Founded
1975
Parent company
Fresenius SE & Co. KGaA

Official website

Source: Wikidata (Q650259), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.