The Recall Desk

Manufacturer

Fresenius Medical Care Renal Therapies Group, LLC

36 recalls in our database name Fresenius Medical Care Renal Therapies Group, LLC as the manufacturing or recalling firm.

What the numbers show

Total
36
Critical
0
Severe
13
Most recent
2026-09-30

Of the 36 recalls from Fresenius Medical Care Renal Therapies Group, LLC we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 13 (36%) 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.

1–25 of 36

  • ModerateFDA (Devices)·Z-3225-2026·2026-09-30

    Fresenius CombiSet Hemodialysis Blood Tubing Set Recalled for Handling Review

    Fresenius Medical Care is recalling CombiSet Hemodialysis Blood Tubing Sets to ensure treatment preparation and handling steps are performed as instructed.

    Product
    CombiSet Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors; Model Number: 03-2522-1;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3086-2026·2026-09-09

    Fresenius 5008X HD/HDF Blood Tubing Set Recalled for Leak Risk

    Fresenius Medical Care is recalling 18,600 units of 5008X HD/HDF blood tubing sets due to a heightened probability of blood leaks that could cause blood loss and hypovolemia.

    Product
    5008X HD/HDF with CLiC Blood Tubing Set Part number 03-5300-3C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3085-2026·2026-09-09

    Fresenius 5008X Blood Tubing Set Recalled for Potential Blood Leak

    Fresenius Medical Care is recalling 5008X HD/HDF Standard Blood Tubing Sets due to a heightened probability of blood leak from the Arterial Alpha Clip connection.

    Product
    5008X HD/HDF Standard Blood Tubing Set Part Number 03-5300-3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3084-2026·2026-09-09

    Fresenius Medical Care Recalls 5008X Standard HD Pre-Flush Blood Tubing Sets

    Fresenius Medical Care is recalling 120 units of 5008X Standard HD Pre-Flush Blood Tubing Sets due to a heightened probability of blood leaks during treatment.

    Product
    5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3087-2026·2026-09-09

    Fresenius 5008X HD/HDF Blood Tubing Set Recalled for Leak Risk

    Fresenius Medical Care is recalling 5008X HD/HDF blood tubing sets due to a heightened probability of blood leaks that could cause blood loss and hypovolemia.

    Product
    5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3091-2026·2026-09-09

    Fresenius Recalls Granuflo Dry Acid Concentrate Due to Discoloration

    Fresenius Medical Care is recalling Granuflo Dry Acid Concentrate for hemodialysis due to complaints of blue-green discoloration in the product.

    Product
    GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B; 0FD3251-3B; Dry Acid Concentrate for Bicarbonate Hemodialysis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3092-2026·2026-09-09

    Fresenius NaturaLyte Liquid Acid Concentrate Recalled for Discoloration

    Fresenius Medical Care is recalling NaturaLyte Liquid Acid Concentrate for Bicarbonate Hemodialysis due to reports of blue-green discoloration in the product.

    Product
    NaturaLyte, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-1251-1, 08-2251-0, 08-2301-3, 08-3251-9, 08-3301-2, 13-2201-5, 13-2251-0, 13-3251-9; Liquid Acid Concentrate for Bicarbonate Hemodialysis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3093-2026·2026-09-09

    Fresenius Citrasate Liquid Acid Concentrate Recalled for Discoloration

    Fresenius Medical Care is recalling Citrasate Liquid Acid Concentrate for Bicarbonate Hemodialysis due to complaints of blue-green discoloration.

    Product
    Citrasate, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-2251-CA, 08-3251-CA, 13-2251-CA; Liquid Acid Concentrate for Bicarbonate Hemodialysis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3017-2026·2026-09-02

    Fresenius BlueStar Hemodialysis Machines Recalled for Alarm Defects

    Fresenius Medical Care is recalling 1,140 BlueStar Hemodialysis machines due to reported flow, water, or temperature-related alarms.

    Product
    Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: 191126, 191130.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2151-2019·2019-08-14

    Fresenius Recalls Liberty Cycler Cassettes Due to Potential Solution Leakage

    Fresenius Medical Care is recalling Liberty Cycler Cassettes because damaged units may leak dialysis solution into the cycler, posing a contamination risk.

    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)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1699-2019·2019-06-12

    Fresenius 2008T BlueStar Hemodialysis Machines Recalled for Power Logic Board Fail Message

    Fresenius Medical Care is recalling 257 units of the 2008T BlueStar hemodialysis machine due to a power logic board fail message on 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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0658-2019·2018-12-26

    Fresenius Optiflux F160NR Dialyzers Recalled for Potential Blood Leaks

    Fresenius Medical Care is recalling Optiflux F160NR dialyzers due to a potential for external blood leaks from the dialyzer header.

    Product
    Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0518-2019·2018-12-05

    Fresenius Granuflo Dry Acid Concentrate Recalled for Foreign Substance

    Fresenius Medical Care is recalling Granuflo Dry Acid Concentrate for hemodialysis due to confirmed foreign substance contamination.

    Product
    Fresenius Granuflo Dry Acid Concentrate- 3K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD3251-3B for hemodialysis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0517-2019·2018-12-05

    Fresenius Granuflo Dry Acid Concentrate Recalled for Foreign Substance

    Fresenius Medical Care is recalling specific lots of Granuflo Dry Acid Concentrate for hemodialysis due to 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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0516-2019·2018-12-05

    Fresenius Granuflo Dry Acid Concentrate Recalled for Foreign Substance

    Fresenius Medical Care is recalling Granuflo Dry Acid Concentrate for hemodialysis due to confirmed foreign substance contamination.

    Product
    Fresenius Granuflo Dry Acid Concentrate- 2K 2.0 Ca 1 Mg 16.5 GAL Catalog Number: OFD2201-3B for hemodialysis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3194-2018·2018-09-26

    Fresenius 2008T Hemodialysis Systems Recalled for Disinfectant Exposure Risk

    Fresenius Medical Care is recalling 80 hemodialysis systems because a power failure during cleaning may allow disinfectant to remain in the machine and be delivered to patients.

    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3195-2018·2018-09-26

    Fresenius 2008T Hemodialysis System Recalled for Disinfectant Exposure Risk

    Fresenius Medical Care is recalling 40 units of the 2008T Hemodialysis System because a power failure during cleaning could leave disinfectant in the dialysate delivered to patients.

    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2110-2018·2018-06-13

    Fresenius NaturaLyte Liquid Acid Concentrate Recalled for Mislabeled Part Numbers

    Fresenius Medical Care is recalling NaturaLyte Liquid Acid Concentrate bottles due to incorrect part number labeling.

    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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0827-2018·2018-05-30

    Fresenius Recalls 0.9% Sodium Chloride Injection Due to Sterility Concerns

    Fresenius Medical Care is recalling 25,356 bags of 0.9% Sodium Chloride Injection due to a lack of assurance of sterility.

    Product
    0.9% Sodium Chloride Injection, USP, 1000 mL, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-0300-10.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1365-2018·2018-04-18

    Fresenius Liberty Select Cycler Recalled for Software Overfill Risk

    Fresenius Medical Care is recalling Liberty Select Cyclers due to a software issue that may cause overfill, posing a risk of 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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1278-2018·2018-04-11

    Fresenius K2 Hemodialysis Machines Recalled for SLED Program Software Defect

    Fresenius Medical Care is recalling 127 K2 Hemodialysis Machines because a software defect may allow the ultrafiltration pump to run at unsafe rates during SLED treatments.

    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.
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Drugs)·D-0604-2018·2018-03-28

    Fresenius Recalls DELFLEX Peritoneal Dialysis Solution Due to Bag Leakage

    Fresenius Medical Care is recalling specific lots of DELFLEX Peritoneal Dialysis Solution because bag leakage may compromise sterility.

    Product
    DELFLEX — DELFLEX (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1010-2018·2018-03-21

    Fresenius NaturaLyte Liquid Acid Concentrate Recalled for Potassium Concentration Error

    Fresenius Medical Care is recalling NaturaLyte Liquid Acid Concentrate because some units in the affected lot had a potassium concentration of 2.25 mEq/L instead of the labeled 2.0 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…
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0829-2018·2018-03-07

    Fresenius 2008T Hemodialysis Systems Recalled for Software Anomaly

    Fresenius Medical Care is recalling 15 hemodialysis machines due to a software error that causes a discrepancy between the displayed and actual ultrafiltration rates.

    Product
    2008T, Hemodialysis Delivery System Product Indicated for acute and chronic dialysis therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1026-2017·2017-01-25

    Fresenius 2008T Hemodialysis System Recalled for Software Error

    Fresenius Medical Care is recalling 2008T Series Hemodialysis Systems because a software error may cause the machine to execute a cancelled ultrafiltration rate instead of the displayed rate.

    Product
    Fresenius 2008T Series Hemodialysis System
    Category
    Medical Device
    Distribution
    Distributed nationwide