thejoe Fresenius Medical Care Renal Therapies

Fresenius Medical Care Renal Therapies Group, LLC: 25 FDA recall reports

Every medical device recall the FDA has published for Fresenius Medical Care Renal Therapies Group, LLC. The fault, and how the agency graded it.

25Reports

0Class I

0Ongoing

2019-08-14Most recent

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

Class	What the FDA is saying
Class I	There is a reasonable probability that using this will cause serious harm or death.
Class II	It may cause temporary or reversible harm. Serious harm is unlikely.
Class III	It breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

Class	Reports
Class II	21
Class III	4

By year reported

Year	Reports
2015	3
2016	5
2017	4
2018	11
2019	2

Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

Liberty Cycler Cassettes (a disposable cassette that is intended to be used to perform peritoneal dialysis (AP

Z-2151-2019 · Class II · reported 2019-08-14 · Terminated

Why it was recalled: Additional Instructions: step-by step handling and inserting the cassette into the Liberty Cycler set. A damaged cassette can cause peritoneal dialysis (PD) solution to leak into the cycler and is a potential risk for contamination.
Product: Liberty Cycler Cassettes (a disposable cassette that is intended to be used to perform peritoneal dialysis (APD) in conjunction with the Liberty cycler as follows: (1) LIBERTY Line Cycler Set with Stay-safe connectors (Dual Patient Connector) Part Number: 050-87212 (2) LIBERTY Line Cycler Set with Stay-safe connectors (Single Patient Connector) Part Number: 050-87215 (3) LIBERTY Integrated Cycler Set with single Stay-safe patient connector and extended drain line Part Number: 050-87216
Where it went: US Nationwide Distribution
How much: 33732973 Cassettes; 18,674 Liberty Cyclers

2008T BlueStar Machine Software v.2.72-Hemodialysis machine Model Number: 191126 - Product Usage: The 2008T

Z-1699-2019 · Class III · reported 2019-06-12 · Terminated

Why it was recalled: Power Logic Board Fail Message on the 2008T BlueStar Machine with software version 2.72.
Product: 2008T BlueStar Machine Software v.2.72-Hemodialysis machine Model Number: 191126 - Product Usage: The 2008T hemodialysis machine is indicated for acute and chronic dialysis therapy in a healthcare facility.
Where it went: US Nationwide distribution.
How much: 257 units

Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E

Z-0658-2019 · Class II · reported 2018-12-26 · Terminated

Why it was recalled: Potential for external blood leaks from the dialyzer header
Product: Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E
Where it went: US Nationwide
How much: 9,097 cs x 12 units each

Fresenius Granuflo Dry Acid Concentrate- 2K 2.0 Ca 1 Mg 16.5 GAL Catalog Number: OFD2201-3B for hemodialysis

Z-0516-2019 · Class III · reported 2018-12-05 · Terminated

Why it was recalled: Discolored powder has confirmed the presence of a foreign substance
Product: Fresenius Granuflo Dry Acid Concentrate- 2K 2.0 Ca 1 Mg 16.5 GAL Catalog Number: OFD2201-3B for hemodialysis
Where it went: Distribution US nationwide and Mexico
How much: 4752

Fresenius Granuflo Dry Acid Concentrate- 2K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD2251-3B for hemodialysis

Z-0517-2019 · Class III · reported 2018-12-05 · Terminated

Why it was recalled: Discolored powder has confirmed the presence of a foreign substance
Product: Fresenius Granuflo Dry Acid Concentrate- 2K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD2251-3B for hemodialysis
Where it went: Distribution US nationwide and Mexico
How much: 92225

Fresenius Granuflo Dry Acid Concentrate- 3K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD3251-3B for hemodialy

Z-0518-2019 · Class III · reported 2018-12-05 · Terminated

Why it was recalled: Discolored powder has confirmed the presence of a foreign substance
Product: Fresenius Granuflo Dry Acid Concentrate- 3K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD3251-3B for hemodialysis
Where it went: Distribution US nationwide and Mexico
How much: 22320

2008T HEMODIALYSIS SYSTEM W/BIBAG, Part Number 190766, Applicable only with 2008T BlueStar Premium Upgrade Kit

Z-3195-2018 · Class II · reported 2018-09-26 · Terminated

Why it was recalled: In the hemodialysis machine during the cleaning/disinfection program, when there is a power failure or interruption, the dialysis program button should be greyed out when the machine is powered up and a mandatory rinse should be required. However, if a power failure or interruption occurs during the cleaning/disinfection program with the auto-start feature enabled, the machine enters the dialysis program even though the dialysis program button is disabled and the mandatory rinse has not been performed. As a result, disinfecting chemical may not be completely removed from the machine before starting a treatment and disinfectant could exist in the dialysate delivered to the patient.
Product: 2008T HEMODIALYSIS SYSTEM W/BIBAG, Part Number 190766, Applicable only with 2008T BlueStar Premium Upgrade Kit, Part Number 191138 Product Usage: Indicated for acute and chronic dialysis therapy.
Where it went: US Nationwide in the states of : CA, CT, MI, NC, and NY.
How much: 40

2008T HEMODIALYSIS SYS, WITH CDX, Part Number 190713, Applicable only with 2008T BlueStar Premium Upgrade Kit,

Z-3194-2018 · Class II · reported 2018-09-26 · Terminated

Why it was recalled: In the hemodialysis machine during the cleaning/disinfection program, when there is a power failure or interruption, the dialysis program button should be greyed out when the machine is powered up and a mandatory rinse should be required. However, if a power failure or interruption occurs during the cleaning/disinfection program with the auto-start feature enabled, the machine enters the dialysis program even though the dialysis program button is disabled and the mandatory rinse has not been performed. As a result, disinfecting chemical may not be completely removed from the machine before starting a treatment and disinfectant could exist in the dialysate delivered to the patient.
Product: 2008T HEMODIALYSIS SYS, WITH CDX, Part Number 190713, Applicable only with 2008T BlueStar Premium Upgrade Kit, Part Number 191138 Product Usage: Indicated for acute and chronic dialysis therapy.
Where it went: US Nationwide in the states of : CA, CT, MI, NC, and NY.
How much: 80

NaturaLyte¿ Liquid Acid Concentrate for Bicarbonate Dialysis, 3.43 Liters, Part Number: 08-3231-1 Product U

Z-2110-2018 · Class II · reported 2018-06-13 · Terminated

Why it was recalled: The bottles are mislabeled with an incorrect part number.
Product: NaturaLyte¿ Liquid Acid Concentrate for Bicarbonate Dialysis, 3.43 Liters, Part Number: 08-3231-1 Product Usage: This concentrate is formulated to be used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine. For every 45 volume parts of dialysate: 1 volume part of the NaturaLyte acid concentrate, 1.72 volume parts of FMCNA Sodium Bicarbonate Concentrate and 42.28 volume parts of Purified Water (AAMI quality) are used.
Where it went: Worldwide Distribution - US Nationwide in the states: CA, IA, IL, IN, KS, MD, MI, MN, MS, NE, NJ, NV, OK, PA, SD, TX, and WI.
How much: 1060 cases (4240 bottles)

Liberty Select Cycler (SW v.2.8.7), Material Number RTLR108343 Product Usage: The device is indicated for

Z-1365-2018 · Class II · reported 2018-04-18 · Terminated

Why it was recalled: The recalling firm identified a software issue related to the Patient Line Check (PLC) which may result in an increased risk of Overfill (also known as Increased Intraperitoneal Volume, IIPV). Overfill/IIPV may result in serious injury or death.
Product: Liberty Select Cycler (SW v.2.8.7), Material Number RTLR108343 Product Usage: The device is indicated for acute and chronic peritoneal dialysis.
Where it went: Nationwide distribution.
How much: 9293

2008 K2 Hemodialysis Machine with software version 5.40, Models: (1) Hemodialysis SYS OLC/Diasafe PLS 190610,

Z-1278-2018 · Class II · reported 2018-04-11 · Terminated

Why it was recalled: When the recirculation ultrafiltration (UF) Goal is set to a value greater than 200ml in service mode and the user starts a treatment using the SLED (Sustained Low Efficiency Dialysis) program the display will show an invalid message and the UF pump will run at the recirculation UF rate which may be up to 4000ml/hour. The SLED program is required to limit the UF rate to a maximum of 1000 ml/hour.
Product: 2008 K2 Hemodialysis Machine with software version 5.40, Models: (1) Hemodialysis SYS OLC/Diasafe PLS 190610, UDI 00840861100859 (+Serial Number), (2) Machine Short Cap, OLC.DP HP 190630, UDI 00840861100866 (+Serial Number) ndicated for acute and chronic dialysis therapy.
Where it went: US Distribution to the states of: AR, CA, CO, FL, GA, IL, MA, MD, MN, NC, NY, OH, PA, SC, TN, and TX.
How much: 127

NaturaLyte¿ Liquid Acid Concentrate 2.0 mEq/L, Model # 08-2251-0 3.43 liter bottle This concentrate is fo

Z-1010-2018 · Class II · reported 2018-03-21 · Terminated

Why it was recalled: The label specifies the potassium concentration is 2.0 mEq/L. Some of the product in the affected lot was found to have a potassium concentration of 2.25 mEq/L.
Product: NaturaLyte¿ Liquid Acid Concentrate 2.0 mEq/L, Model # 08-2251-0 3.43 liter bottle This concentrate is formulated to be used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
Where it went: US Distribution to states of: CA, FL, KS, LA, and TX.
How much: 598 cases

2008T, Hemodialysis Delivery System Product Indicated for acute and chronic dialysis therapy.

Z-0829-2018 · Class II · reported 2018-03-07 · Terminated

Why it was recalled: While reviewing documentation for the next software release of the 2008T, an R&D technician identified that setting the UF goal to '0' introduces a discrepancy between the UF rate displayed and the actual UF pump rate. The software anomaly is also applicable to the 2008T Machines that contained the 2.63 Bug Fix per DCAF 17-088. 2008T Upgrade kits that contained the 2.63 Bug Fix are also affected. Additionally, SW version 2.64 (in design freeze) is also impacted by this anomaly.
Product: 2008T, Hemodialysis Delivery System Product Indicated for acute and chronic dialysis therapy.
Where it went: US Nationwide Distribution
How much: 15 machines

Fresenius 2008K@home Series : Hemodialysis System

Z-1029-2017 · Class II · reported 2017-01-25 · Terminated

Why it was recalled: When the UF Rate, Goal or Time is adjusted using the up and down arrow keys, and the change is cancelled by using the esc key, the cancelled UF Rate is actually being executed rather than rate displayed on the machine
Product: Fresenius 2008K@home Series : Hemodialysis System
Where it went: Nationwide Foreign: Canada, Mexico, Jamaica, Germany, Guam
How much: 1400 units (US) 556 units (OUS)

Fresenius 2008K2 Series : Hemodialysis System

Z-1028-2017 · Class II · reported 2017-01-25 · Terminated

Why it was recalled: When the UF Rate, Goal or Time is adjusted using the up and down arrow keys, and the change is cancelled by using the esc key, the cancelled UF Rate is actually being executed rather than rate displayed on the machine
Product: Fresenius 2008K2 Series : Hemodialysis System
Where it went: Nationwide Foreign: Canada, Mexico, Jamaica, Germany, Guam
How much: 60,151 units (US) 1773 (OUS)

Fresenius 2008T Series Hemodialysis System

Z-1026-2017 · Class II · reported 2017-01-25 · Terminated

Why it was recalled: When the UF Rate, Goal or Time is adjusted using the up and down arrow keys, and the change is cancelled by using the esc key, the cancelled UF Rate is actually being executed rather than rate displayed on the machine
Product: Fresenius 2008T Series Hemodialysis System
Where it went: Nationwide Foreign: Canada, Mexico, Jamaica, Germany, Guam
How much: 65361 units (US) 249 units (OUS)

Fresenius 2008K Series : Hemodialysis System

Z-1027-2017 · Class II · reported 2017-01-25 · Terminated

Why it was recalled: When the UF Rate, Goal or Time is adjusted using the up and down arrow keys, and the change is cancelled by using the esc key, the cancelled UF Rate is actually being executed rather than rate displayed on the machine
Product: Fresenius 2008K Series : Hemodialysis System
Where it went: Nationwide Foreign: Canada, Mexico, Jamaica, Germany, Guam
How much: 78481 (US) 2734 units (OUS)

Crit Line in a Clip (CLiC). CliC P/N: CL 10041001 CLiC is a continuous real-time monitor for non-invasive hem

Z-2044-2016 · Class II · reported 2016-06-29 · Terminated

Why it was recalled: Use of the Blood Pressure Graph located on the Crit-Line screen of the 2008T Hemodialysis Machine may result in a frozen screen, possibly causing the blood pump to stop.
Product: Crit Line in a Clip (CLiC). CliC P/N: CL 10041001 CLiC is a continuous real-time monitor for non-invasive hematocrit oxygen saturation and percent change in blood volume measurement during hemodialysis treatment. Used in conjunction with the Fresenius 2008T Hemodialysis Machines as follows: Model: 190895 2008T GEN 2 BIBAG w/o CDX 190713 2008T Hemodialysis SYS with CDX 190858 2008T Hemodialysis System w/o CDX 190766 2008T Hemodialysis System w/o CDX
Where it went: Distributed US (nationwide)
How much: 875 units

Fresenius 2008 Series Hemodialysis Delivery Systems: 2008T, 2008K2, 2008K and 2008K@home: Models: Fresenius

Z-1325-2016 · Class II · reported 2016-04-13 · Terminated

Why it was recalled: Added Warning Statement: Fresenius 2008 Series Hemodialysis Machines False Blood Leak Alarm When Dialyzing Patients Treated with Hydroxocobalamin (or any form of Vitamin B-12)
Product: Fresenius 2008 Series Hemodialysis Delivery Systems: 2008T, 2008K2, 2008K and 2008K@home: Models: Fresenius 2008K and 2008K2 Dialysate Delivery System Fresenius 2008K@home Hemodialysis Machine with bibag System 2008T Hemodialysis Machine The Fresenius 2008¿ Series Machines are indicated for acute and chronic dialysis therapy
Where it went: Nationwide Distribution
How much: 8384 units (8369 US) (15 OUS)

Fresenius Hemoflow F3 Dialyzer Part Number: 0520165A Indicated for Acute and Chronic Hemodialysis

Z-1324-2016 · Class II · reported 2016-04-13 · Terminated

Why it was recalled: Dialyzer header leak due to possible improper torque
Product: Fresenius Hemoflow F3 Dialyzer Part Number: 0520165A Indicated for Acute and Chronic Hemodialysis
Where it went: US Nationwide Distribution including states of: AZ, CA, CT, DC, GA, IL, IN, MI, MN, MO, MS, NY, OH, PA, SC, SD, TX, and WA.
How much: 1,650 units

Fresenius Naturalyte Liquid Acid Concentrate Catalog Number: 08-2301-3 Intended Use: Acid Concentrate for

Z-0887-2016 · Class II · reported 2016-03-02 · Terminated

Why it was recalled: On the label calcium (Ca) listed in the right upper corner of the label (red background) incorrectly indicates the product contains 2.5 mEq/L Ca. The concentration indicated in the list of constituents represents the actual calcium concentration of the final dialysate, 3.0 mEq/L.
Product: Fresenius Naturalyte Liquid Acid Concentrate Catalog Number: 08-2301-3 Intended Use: Acid Concentrate for Bicarbonate Dialysis
Where it went: US Distribution to states of: KS, LA, MS, OK, and TX.
How much: 848 (212 cases)

Fresenius Liberty Cycler-Peritoneal Dialysis Cycler Model: 180111 and RTLR180111

Z-0693-2016 · Class II · reported 2016-02-03 · Terminated

Why it was recalled: The door latch may not fully close and the door may open unexpectedly. The door may make physical contact with anything near the door of the machine, including the patient. May cause injury, delay in treatment, or Increased Intraperitoneal Volume (IIPV) (overfill).
Product: Fresenius Liberty Cycler-Peritoneal Dialysis Cycler Model: 180111 and RTLR180111
Where it went: Nationwide Distribution
How much: 14,094 units

Fresenius 132 Gallon Dry Acid Dissolution Unit, P/N 160147. For Use in the Preparation of acid concentrate

Z-0295-2016 · Class II · reported 2015-11-25 · Terminated

Why it was recalled: Dissolution units and replacement motors units do not provide full thermal protection for both the Main and Starter coils resulting in the generation of smoke and/or potentially lead to fire.
Product: Fresenius 132 Gallon Dry Acid Dissolution Unit, P/N 160147. For Use in the Preparation of acid concentrate for hemodialysis.
Where it went: Nationwide Distribution.
How much: 348 units

Fresenius Modified Mixer Motor (for 132 Gallon Dissolution Units), P/N 160075. For Use in the Preparation o

Z-0296-2016 · Class II · reported 2015-11-25 · Terminated

Why it was recalled: Dissolution units and replacement motors units do not provide full thermal protection for both the Main and Starter coils resulting in the generation of smoke and/or potentially lead to fire.
Product: Fresenius Modified Mixer Motor (for 132 Gallon Dissolution Units), P/N 160075. For Use in the Preparation of acid concentrate for hemodialysis.
Where it went: Nationwide Distribution.
How much: 992 units

Fresenius 132 Gallon GranuFlo Dissolution Unit - P/N G047-80101. For Use in the Preparation of acid concent

Z-0294-2016 · Class II · reported 2015-11-25 · Terminated

Why it was recalled: Dissolution units and replacement motors units do not provide full thermal protection for both the Main and Starter coils resulting in the generation of smoke and/or potentially lead to fire.
Product: Fresenius 132 Gallon GranuFlo Dissolution Unit - P/N G047-80101. For Use in the Preparation of acid concentrate for hemodialysis.
Where it went: Nationwide Distribution.
How much: 918 units

Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

← All device recalls