Fresenius Medical Care Renal Therapies Group recalls
Fresenius Medical Care Renal Therapies Group appears in 36 official U.S. recall notices indexed by RecallRadar, most recently on 2026-09-30.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 36 |
|---|---|
| Published | 2015-11-25 to 2026-09-30 |
| By agency | FDA Device (34), FDA Drug (2) |
| By classification | Class II (32), Class III (4) |
| By status | terminated (27), ongoing (9) |
| Distribution named in notices | AR, CA, CO, FL, GA, IL, KS, LA, MA, MD, MN, MS, NC, NY, OH, OK, PA, SC, TN, TX, US |
Recalls
- CombiSet Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors
FDA Device · Class II · 2026-09-30 · Fresenius Medical Care Renal Therapies Group
Reason: Communication to recommend reviewing the IFU and ensuring that all treatment preparation and handling steps are performed as instructed. - 5008X HD/HDF with CLiC Blood Tubing Set Part number 03-5300-3C
FDA Device · Class II · 2026-09-09 · Fresenius Medical Care Renal Therapies Group
Reason: Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia. - 5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6
FDA Device · Class II · 2026-09-09 · Fresenius Medical Care Renal Therapies Group
Reason: Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia. - NaturaLyte, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-1251-1, 08-2251-0, 08-2301-3, 08-3251-9, 08-3301-2, 1…
FDA Device · Class II · 2026-09-09 · Fresenius Medical Care Renal Therapies Group
Reason: Complaints of blue-green discoloration in product - GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B
FDA Device · Class II · 2026-09-09 · Fresenius Medical Care Renal Therapies Group
Reason: Complaints of blue-green discoloration in product - 5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8
FDA Device · Class II · 2026-09-09 · Fresenius Medical Care Renal Therapies Group
Reason: Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia. - Citrasate, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-2251-CA, 08-3251-CA, 13-2251-CA
FDA Device · Class II · 2026-09-09 · Fresenius Medical Care Renal Therapies Group
Reason: Complaints of blue-green discoloration in product - 5008X HD/HDF Standard Blood Tubing Set Part Number 03-5300-3
FDA Device · Class II · 2026-09-09 · Fresenius Medical Care Renal Therapies Group
Reason: Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia. - Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: 191126, 191130
FDA Device · Class II · 2026-09-02 · Fresenius Medical Care Renal Therapies Group
Reason: Fresenius Medical Care Renal Therapies Group, LLC (FMCRTG) has received complaints regarding flow-, no water-, or temperature-related alarms with the 2008T¿ BlueStar Hemodialysis machines. - Liberty Cycler Cassettes (a disposable cassette that is intended to be used to perform peritoneal dialysis (APD) in conjunction with the Li…
FDA Device · Class II · 2019-08-14 · Fresenius Medical Care Renal Therapies Group
Reason: 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 c… - 2008T BlueStar Machine Software v.2.72-Hemodialysis machine Model Number: 191126 - Product Usage: The 2008T hemodialysis machine is indicat…
FDA Device · Class III · 2019-06-12 · Fresenius Medical Care Renal Therapies Group
Reason: Power Logic Board Fail Message on the 2008T BlueStar Machine with software version 2.72. - Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E
FDA Device · Class II · 2018-12-26 · Fresenius Medical Care Renal Therapies Group
Reason: Potential for external blood leaks from the dialyzer header - Fresenius Granuflo Dry Acid Concentrate- 3K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD3251-3B for hemodialysis
FDA Device · Class III · 2018-12-05 · Fresenius Medical Care Renal Therapies Group
Reason: Discolored powder has confirmed the presence of a foreign substance - Fresenius Granuflo Dry Acid Concentrate- 2K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD2251-3B for hemodialysis
FDA Device · Class III · 2018-12-05 · Fresenius Medical Care Renal Therapies Group
Reason: Discolored powder has confirmed the presence of a foreign substance - Fresenius Granuflo Dry Acid Concentrate- 2K 2.0 Ca 1 Mg 16.5 GAL Catalog Number: OFD2201-3B for hemodialysis
FDA Device · Class III · 2018-12-05 · Fresenius Medical Care Renal Therapies Group
Reason: Discolored powder has confirmed the presence of a foreign substance - 2008T HEMODIALYSIS SYS, WITH CDX, Part Number 190713, Applicable only with 2008T BlueStar Premium Upgrade Kit, Part Number 191138 Product U…
FDA Device · Class II · 2018-09-26 · Fresenius Medical Care Renal Therapies Group
Reason: 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… - 2008T HEMODIALYSIS SYSTEM W/BIBAG, Part Number 190766, Applicable only with 2008T BlueStar Premium Upgrade Kit, Part Number 191138 Product…
FDA Device · Class II · 2018-09-26 · Fresenius Medical Care Renal Therapies Group
Reason: 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… - NaturaLyte¿ Liquid Acid Concentrate for Bicarbonate Dialysis, 3.43 Liters, Part Number: 08-3231-1 Product Usage: This concentrate is formul…
FDA Device · Class II · 2018-06-13 · Fresenius Medical Care Renal Therapies Group
Reason: The bottles are mislabeled with an incorrect part number. - 0.9% Sodium Chloride Injection, USP, 1000 mL, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-0300-10
FDA Drug · Class II · 2018-05-30 · Fresenius Medical Care Renal Therapies Group
Reason: Lack of Assurance of Sterility - Liberty Select Cycler (SW v.2.8.7), Material Number RTLR108343 Product Usage: The device is indicated for acute and chronic peritoneal dial…
FDA Device · Class II · 2018-04-18 · Fresenius Medical Care Renal Therapies Group
Reason: 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 i… - 2008 K2 Hemodialysis Machine with software version 5.40, Models: (1) Hemodialysis SYS OLC/Diasafe PLS 190610, UDI 00840861100859 (+Serial N…
FDA Device · Class II · 2018-04-11 · Fresenius Medical Care Renal Therapies Group
Reason: 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 i… - DELFLEX Peritoneal Dialysis Solution, 2.5% Low Mg/Low Ca Single Bag, packaged in a) 3L (4 pack, NDC 49230-209-30), b) 2 L(6 pack NDC 49230-…
FDA Drug · Class II · 2018-03-28 · Fresenius Medical Care Renal Therapies Group
Reason: Lack of Assurance of Sterility: Leakage of the peritoneal dialysis (PD) solution bag. - 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…
FDA Device · Class II · 2018-03-21 · Fresenius Medical Care Renal Therapies Group
Reason: 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. - 2008T, Hemodialysis Delivery System Product Indicated for acute and chronic dialysis therapy
FDA Device · Class II · 2018-03-07 · Fresenius Medical Care Renal Therapies Group
Reason: 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.… - Fresenius 2008K@home Series : Hemodialysis System
FDA Device · Class II · 2017-01-25 · Fresenius Medical Care Renal Therapies Group
Reason: 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 m… - Fresenius 2008T Series Hemodialysis System
FDA Device · Class II · 2017-01-25 · Fresenius Medical Care Renal Therapies Group
Reason: 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 m… - Fresenius 2008K2 Series : Hemodialysis System
FDA Device · Class II · 2017-01-25 · Fresenius Medical Care Renal Therapies Group
Reason: 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 m… - Fresenius 2008K Series : Hemodialysis System
FDA Device · Class II · 2017-01-25 · Fresenius Medical Care Renal Therapies Group
Reason: 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 m… - 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…
FDA Device · Class II · 2016-06-29 · Fresenius Medical Care Renal Therapies Group
Reason: 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. - Fresenius 2008 Series Hemodialysis Delivery Systems: 2008T, 2008K2, 2008K and 2008K@home: Models: Fresenius 2008K and 2008K2 Dialysate Deli…
FDA Device · Class II · 2016-04-13 · Fresenius Medical Care Renal Therapies Group
Reason: 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) - Fresenius Hemoflow F3 Dialyzer Part Number: 0520165A Indicated for Acute and Chronic Hemodialysis
FDA Device · Class II · 2016-04-13 · Fresenius Medical Care Renal Therapies Group
Reason: Dialyzer header leak due to possible improper torque - Fresenius Naturalyte Liquid Acid Concentrate Catalog Number: 08-2301-3 Intended Use: Acid Concentrate for Bicarbonate Dialysis
FDA Device · Class II · 2016-03-02 · Fresenius Medical Care Renal Therapies Group
Reason: 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 ac… - Fresenius Liberty Cycler-Peritoneal Dialysis Cycler Model: 180111 and RTLR180111
FDA Device · Class II · 2016-02-03 · Fresenius Medical Care Renal Therapies Group
Reason: 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 Incre… - Fresenius 132 Gallon GranuFlo Dissolution Unit - P/N G047-80101
FDA Device · Class II · 2015-11-25 · Fresenius Medical Care Renal Therapies Group
Reason: 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. - Fresenius 132 Gallon Dry Acid Dissolution Unit, P/N 160147
FDA Device · Class II · 2015-11-25 · Fresenius Medical Care Renal Therapies Group
Reason: 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. - Fresenius Modified Mixer Motor (for 132 Gallon Dissolution Units), P/N 160075
FDA Device · Class II · 2015-11-25 · Fresenius Medical Care Renal Therapies Group
Reason: 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.