Waltham, MA, United States
Fresenius Medical Care Renal Therapies Group, LLC recalls
16 recalls recorded since 2018, most recently on 10 August 2026. 4 are listed as ongoing. Status and classification are as published by the FDA.
Recalls16
Ongoing (FDA)4
Terminated or completed12
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 10 August 2026
- 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.
- Distribution
- Worldwide - US Nationwide distribution in the states of AL, CA, CO, FL, GA, IL, KY, LA, MA, MD, MN, MO, NC, NH, NH, NY, OH, PA, TN, TX, VA and the country of Lithuania.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3087-2026, Z-3084-2026, Z-3085-2026, Z-3086-2026
- 5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8
- 5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6
- 5008X HD/HDF Standard Blood Tubing Set Part Number 03-5300-3
- 5008X HD/HDF with CLiC Blood Tubing Set Part number 03-5300-3C
Ongoing Class II Medical devices
- Recall started
- 29 July 2026
- Reason
- Communication to recommend reviewing the IFU and ensuring that all treatment preparation and handling steps are performed as instructed.
- Distribution
- Domestic: Nationwide Distribution;
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3225-2026
- CombiSet Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors; Model Number: 03-2522-1;
Ongoing Class II Medical devices
- Recall started
- 14 July 2026
- Reason
- Complaints of blue-green discoloration in product
- Distribution
- Worldwide distribution - US Nationwide and the country of Mexico.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3091-2026, Z-3092-2026, Z-3093-2026
- GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B; 0FD3251-3B; Dry Acid Concentrate for Bicarbonate Hemodialysis
- 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 Hemodia
- Citrasate, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-2251-CA, 08-3251-CA, 13-2251-CA; Liquid Acid Concentrate for Bicarbonate Hemodialysis
Ongoing Class II Medical devices
- Recall started
- 30 June 2026
- 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.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3017-2026
- Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: 191126, 191130.
Terminated Class II Medical devices
- Recall started
- 29 May 2019
- Terminated
- 19 November 2020
- 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 contamination.
- Distribution
- US Nationwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2151-2019
- 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 (
Terminated Class III Medical devices
- Recall started
- 3 April 2019
- Terminated
- 30 August 2019
- Reason
- Power Logic Board Fail Message on the 2008T BlueStar Machine with software version 2.72.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1699-2019
- 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.
Terminated Class II Medical devices
- Recall started
- 5 November 2018
- Terminated
- 17 April 2023
- Reason
- Potential for external blood leaks from the dialyzer header
- Distribution
- US Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0658-2019
- Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E
Terminated Class III Medical devices
- Recall started
- 9 October 2018
- Terminated
- 5 August 2021
- Reason
- Discolored powder has confirmed the presence of a foreign substance
- Distribution
- Distribution US nationwide and Mexico
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0516-2019, Z-0517-2019, Z-0518-2019
- Fresenius Granuflo Dry Acid Concentrate- 2K 2.0 Ca 1 Mg 16.5 GAL Catalog Number: OFD2201-3B for hemodialysis
- Fresenius Granuflo Dry Acid Concentrate- 2K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD2251-3B for hemodialysis
- Fresenius Granuflo Dry Acid Concentrate- 3K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD3251-3B for hemodialysis
Terminated Class II Medical devices
- Recall started
- 13 July 2018
- Terminated
- 17 September 2019
- 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 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.
- Distribution
- US Nationwide in the states of : CA, CT, MI, NC, and NY.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3195-2018, Z-3194-2018
- 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.
- 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.
Terminated Class II Medical devices
- Recall started
- 2 May 2018
- Terminated
- 13 May 2020
- Reason
- The bottles are mislabeled with an incorrect part number.
- Distribution
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2110-2018
- 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 Bicar
Terminated Class II Medical devices
- Recall started
- 24 January 2018
- Terminated
- 11 May 2020
- 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 in serious injury or death.
- Distribution
- Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1365-2018
- Liberty Select Cycler (SW v.2.8.7), Material Number RTLR108343 Product Usage: The device is indicated for acute and chronic peritoneal dialysis.
Terminated Class II Drugs
- Recall started
- 20 December 2017
- Terminated
- 14 February 2019
- Reason
- Lack of Assurance of Sterility: Leakage of the peritoneal dialysis (PD) solution bag.
- Distribution
- Product was distributed throughout the United States to patients and clinics.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0604-2018
- 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 49230-209-23), Rx only, Fresenius Medical Care NA, Waltham, MA 02451.
Terminated Class II Medical devices
- Recall started
- 14 December 2017
- Terminated
- 22 September 2021
- 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 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.
- Distribution
- US Distribution to the states of: AR, CA, CO, FL, GA, IL, MA, MD, MN, NC, NY, OH, PA, SC, TN, and TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1278-2018
- 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 Numb
Terminated Class II Drugs
- Recall started
- 13 November 2017
- Terminated
- 6 December 2018
- Reason
- Lack of Assurance of Sterility
- Distribution
- Product was distributed throughout the United States.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0827-2018
- 0.9% Sodium Chloride Injection, USP, 1000 mL, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-0300-10.
Terminated Class II Medical devices
- Recall started
- 5 October 2017
- Terminated
- 28 July 2021
- 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. 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.
- Distribution
- US Nationwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0829-2018
- 2008T, Hemodialysis Delivery System Product Indicated for acute and chronic dialysis therapy.
Terminated Class II Medical devices
- Recall started
- 29 September 2017
- Terminated
- 9 August 2018
- 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.
- Distribution
- US Distribution to states of: CA, FL, KS, LA, and TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1010-2018
- 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 compa
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.