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Fresenius Medical Care Holdings, Inc.

Fresenius Medical Care Holdings, Inc. Recalls

All product recalls associated with Fresenius Medical Care Holdings, Inc..

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Recall Summary

Total Recalls

Past Year

Class I (Serious)

Most Recent

Oct 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 61–80 of 84 recalls

DELFLEX Peritoneal Dialysis Solution (Fresenius) – Temperature Abuse (2021)

Temperature Abuse: Product exposed to temperature outside specified limits.

Class IIILow

FDAApr 28, 2021Nationwide• Fresenius Medical Care Holdings, Inc.

DELFLEX Peritoneal Dialysis Solution (Fresenius) – Temperature Abuse (2021)

Temperature Abuse: Product exposed to temperature outside specified limits.

Class IIILow

FDAApr 28, 2021Nationwide• Fresenius Medical Care Holdings, Inc.

DELFLEX Peritoneal Dialysis Solution (Fresenius) – Temperature Abuse (2021)

Temperature Abuse: Product exposed to temperature outside specified limits.

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Class III

Low

FDAApr 28, 2021Nationwide• Fresenius Medical Care Holdings, Inc.

DELFLEX Peritoneal Dialysis Solution (Fresenius) – Temperature Abuse (2021)

Temperature Abuse: Product exposed to temperature outside specified limits.

Class IIILow

FDAApr 28, 2021Nationwide• Fresenius Medical Care Holdings, Inc.

Fresenius Medical Care Holdings, Inc.: 026-20036A Liberty Drain Line, Luer Tap For patients with...

Exposed to freezing temperatures due to refrigerated truck malfunctions

FDAApr 28, 2021TX• Fresenius Medical Care Holdings, Inc.

Fresenius Medical Care Holdings, Inc.: (1) 08-4078-BB BIBAG 650 GRAMS/BAG 16 BAGS/CASE (2) 08-4...

Exposed to freezing temperatures due to refrigerated truck malfunctions

FDAApr 28, 2021TX• Fresenius Medical Care Holdings, Inc.

Fresenius Medical Care Holdings, Inc.: The Drain Bag Set (tubings and flexible bags) is a passiv...

Exposed to freezing temperatures due to refrigerated truck malfunctions

FDAApr 28, 2021TX• Fresenius Medical Care Holdings, Inc.

DELFLEX Peritoneal Dialysis Solution (Fresenius) – Temperature Abuse (2021)

Temperature Abuse: Product exposed to temperature outside specified limits.

Class IIILow

FDAApr 28, 2021Nationwide• Fresenius Medical Care Holdings, Inc.

Fresenius Medical Care Holdings, Inc.: The Fresenius APD Luer-Lock Adapter, Catalog number 050-9...

Exposed to freezing temperatures due to refrigerated truck malfunctions

FDAApr 28, 2021TX• Fresenius Medical Care Holdings, Inc.

Fresenius Medical Care Holdings, Inc.: AquaBplus and AquaBplus B2 Water Purification System - Pr...

AquaBplus HF module on the AquaBplus 2500 osmosis system, an error in the US Installation Guideline instructed that 3-ring mains, instead of 2-ring mains, may be installed in combination with an AquaBplus 2500 device. The 3-ring main and fluid fly loops the heat disinfection may not be as effective as a 2-ring main installation

FDAMar 18, 2021Nationwide• Fresenius Medical Care Holdings, Inc.

Fresenius Medical Care Holdings, Inc.: Fresenius Medical Care NaturaLyte Liquid Acid concentrate...

Bottles Missing Product Label

FDADec 17, 2020Nationwide• Fresenius Medical Care Holdings, Inc.

Fresenius Medical Care Holdings, Inc.: Citrasate Liquid Acid concentrate bottles, Product Code 0...

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.

FDANov 23, 2020Nationwide• Fresenius Medical Care Holdings, Inc.

Fresenius Medical Care Holdings, Inc.: Naturalyte Liquid Acid concentrate bottles, Product Code ...

FDANov 23, 2020Nationwide• Fresenius Medical Care Holdings, Inc.

Fresenius Medical Care Holdings, Inc.: Citrasate Liquid Acid concentrate bottles, Model Number 0...

The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.

FDANov 7, 2020Nationwide• Fresenius Medical Care Holdings, Inc.

Fresenius Medical Care Holdings, Inc.: NaturaLyte Liquid Acid concentrate bottles, Model Number ...

The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.

FDANov 7, 2020Nationwide• Fresenius Medical Care Holdings, Inc.

Fresenius Medical Care Holdings, Inc.: Liberty Select Cycler Software Version 2.9.0 Model Number...

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.

FDASep 12, 2020Nationwide• Fresenius Medical Care Holdings, Inc.

Fresenius Medical Care Holdings, Inc.: AquaBplus and AquaBplus B2 Water Purification System. Fo...

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.

FDASep 1, 2020DE, NC, OK +2 more• Fresenius Medical Care Holdings, Inc.

Fresenius Medical Care Holdings, Inc.: Fresenius 2008T Hemodialysis Machine: Part Number Descri...

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

FDAMar 12, 2020Nationwide• Fresenius Medical Care Holdings, Inc.

Fresenius Medical Care Holdings, Inc.: Fresenius 2008T BlueStar Hemodialysis Machine Part Num...

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

FDAMar 12, 2020Nationwide• Fresenius Medical Care Holdings, Inc.

Sodium Chloride Injection (Fresenius) – Sterilization Issue (2020)

CGMP Deviation: Chemical indicators were not positioned properly during sterilization process.

Class IIModerate

FDAMar 5, 2020Nationwide• Fresenius Medical Care Holdings, Inc.