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Fresenius Medical Care Holdings Recalls
166 recalls on record · July 4, 2012 to July 15, 2026 · Drugs, Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
Also filed under
The recall feeds record what looks like the same company under more than one name:
January 20, 2021Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls Naturalyte Liquid Acid concentrate bottles, Product Code 08-1251-1 - Product Usage: used in conjunction with Fresenius R
Hazard: The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing specification.
January 20, 2021Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls Citrasate Liquid Acid concentrate drums, Model Number 13-3251-CA - Product Usage: used in conjunction with Fresenius Ren
Hazard: The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
January 20, 2021Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls Citrasate Liquid Acid concentrate drums, Model Number 13-2251-CA - Product Usage: used in conjunction with Fresenius Ren
Hazard: The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
January 20, 2021Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls Citrasate Liquid Acid concentrate bottles, Model Number 08-3251-CA - Product Usage: used in conjunction with Fresenius R
Hazard: The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
January 20, 2021Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls NaturaLyte Liquid Acid concentrate drums, Model Number 13-3251-9 - Product Usage: used in conjunction with Fresenius Ren
Hazard: The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
January 20, 2021Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls NaturaLyte Liquid Acid concentrate drums, Model Number 13-2251-0 - Product Usage: used in conjunction with Fresenius Ren
Hazard: The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
January 20, 2021Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls NaturaLyte Liquid Acid concentrate drums, Model Number 13-2201-5 - Product Usage: used in conjunction with Fresenius Ren
Hazard: The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
January 20, 2021Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls NaturaLyte Liquid Acid concentrate drums, Model Number 13-1251-1 - Product Usage: used in conjunction with Fresenius Ren
Hazard: The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
January 20, 2021Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls NaturaLyte Liquid Acid concentrate bottles, Model Number 08-4231-0 - Product Usage: used in conjunction with Fresenius R
Hazard: The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
January 20, 2021Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3301-2 - Product Usage: used in conjunction with Fresenius R
Hazard: The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
January 20, 2021Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3251-9 - Product Usage: used in conjunction with Fresenius R
Hazard: The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
January 20, 2021Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3231-1 - Product Usage: used in conjunction with Fresenius R
Hazard: The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
January 20, 2021Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3201-4 - Product Usage: used in conjunction with Fresenius R
Hazard: The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
January 20, 2021Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2351-8 - Product Usage: used in conjunction with Fresenius R
Hazard: The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
January 20, 2021Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2301-3 - Product Usage: used in conjunction with Fresenius R
Hazard: The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
January 20, 2021Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2251-0 - Product Usage: used in conjunction with Fresenius R
Hazard: The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
January 20, 2021Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2231-2 - Product Usage: used in conjunction with Fresenius R
Hazard: The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
January 20, 2021Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2201-5 - Product Usage: used in conjunction with Fresenius R
Hazard: The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
January 20, 2021Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls NaturaLyte Liquid Acid concentrate bottles, Model Number 08-1301-4 - Product Usage: used in conjunction with Fresenius R
Hazard: The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
January 20, 2021Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls NaturaLyte Liquid Acid concentrate bottles, Model Number 08-1251-1 - Product Usage: used in conjunction with Fresenius R
Hazard: The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
November 18, 2020Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls Liberty Select Cycler Software Version 2.9.0 Model Number 180343 and RTLR180343
Hazard: The device may detect an incorrect Heater Bag volume which may lead to a 'Supply Bag Line Blocked' alarm during treatment. This alarm may cause the Heater Bag to contain more fluid than expected and the cycler does not recognize the extra fluid is present and it will not make it available for treatment. Not having enough solution to complete treatment may lead to inadequate dialysis which could result in the accumulation of toxins and fluid. Symptoms may include shortness of breath, increased weight gain, and increased blood pressure.
October 21, 2020Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls AquaBplus and AquaBplus B2 Water Purification System. For use with a hemodialysis system to remove organic and inorgani
Hazard: Incorrectly crimped connectors were installed on the main protective earth conductor on these machines. If the machine is moved or maintenance is performed, these crimp connections could become loose and may adversely affect the electrical safety of the products, potentially resulting in electrical shock to the Biomed Technician or clinic staff.
April 29, 2020Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls Fresenius 2008T BlueStar Hemodialysis Machine Part Number Description: 191124 2008T HD SYS. CDX BLUEST AR; 191126 2
Hazard: A "Remove USB Device 2" false alarm may be displayed when no USB device or a non-powered USB device is connected to the USB port on the rear of the machine
April 29, 2020Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls Fresenius 2008T Hemodialysis Machine: Part Number Description 190573 2008T HEMODIAL YSIS SYS. OLC/DIASAFE PLUS; 19071
Hazard: A "Remove USB Device 2" false alarm may be displayed when no USB device or a non-powered USB device is connected to the USB port on the rear of the machine
April 1, 2020Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls Honeywell Pressure Transducer- Part Number: 370506-22. It is a component used in 2008T, Common Name: Hemodialysis Delive
Hazard: The firm is replacing pressure transducers with an improved design due to an increase in customer complaints regarding lower long-term reliability of the part.
March 25, 2020DrugsFDA
Fresenius Medical Care Holdings, Inc. recalls Sodium Chloride 0.9% Injection, USP, 1000 mL bags, Rx only, Manufactured by: Fresenius Medical Care North America, Walth
Hazard: CGMP Deviation: Chemical indicators were not positioned properly during sterilization process.
August 19, 2015Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls Naturalyte Liquid Bicarbonate Concentrate 6.4 liter bottle A Dialysate Concentrate for Hemodialysis (liquid) Product C
Hazard: Expansion of recall to lots manufactured in 2015 due to the potential for bacterial contamination.
July 1, 2015Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls NaturaLyte Liquid Bicarbonate Concentrate (Dialysate Concentrate for Hemodialysis (liquid), 6.4 Liter Bottle Catalog Nu
Hazard: Bacterial contamination.
June 17, 2015Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls CRIT-LINE Blood Chamber- an accessory to the Crit line III- Monitors in real time blood parameters Model: CL10021021
Hazard: Blood chamber connection leaks during the use of the CRIT-LINE¿ Blood Chamber
May 6, 2015Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls 2008 Series Hemodialysis Machines: 2008K2 with the following product code and description: 190633 2008K2 HEMO SYSTEM, O
Hazard: The Acetate value for GranuFlo on the Select Concentrate screen should be 8mEq/l but it is displayed as 4mEq/l. The correct value is shown on the dialysate screen.