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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 41–60 of 84 recalls

Fresenius Medical Care Holdings, Inc.: NaturaLyte Liquid Acid concentrate, Part Number 08-0231-4...

The "Nominal Chemical Composition" section of the label incorrectly lists 5.62g/L KCL (potassium chloride). 5.62g/L actually corresponds to the CaCl (calcium chloride) content. The product remains potassium free.

FDAOct 4, 2022AL, AZ, CA +18 more• Fresenius Medical Care Holdings, Inc.

Fresenius Medical Care Holdings, Inc.: 2008T and 2008TBluestar Hemodialysis Machines with CDX-I...

(1)Software version 2.74 upgrade and (2)hardware related cause that affects only CDX Machines, has been identified as the UI-MICs Board is sensitive to Electromagnetic Interference (EMI) which will cause the false alarm "Remove USB 2 Device".

FDAJul 27, 2022Nationwide• Fresenius Medical Care Holdings, Inc.

Fresenius Medical Care Holdings, Inc.: AquaC UNO H [120V, 60Hz, 1700VA, US-Version- a reverse os...

Internal ethemet cables are missing one or both ferrite cores therefore the electromagnetic compatibility of the device is not ensured

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FDAJun 21, 2022Nationwide• Fresenius Medical Care Holdings, Inc.

Fresenius Medical Care Holdings, Inc.: AquaC UNO H [120V, 60Hz, 1000VA, US-Version - a reverse o...

Internal ethemet cables are missing one or both ferrite cores therefore the electromagnetic compatibility of the device is not ensured

FDAJun 21, 2022Nationwide• Fresenius Medical Care Holdings, Inc.

Fresenius Medical Care Holdings, Inc.: AquaC UNO H [120V, 60Hz, 1700VA, Fresenius US-Version: 2...

Internal ethernet cable may be misaligned, the cable jacket (insulation) could become compromised due to high temperature and result in the internal ethernet cable conducting electrical current to the ethernet port on the outside of the device), potentially harming service technicians and/or other authorized operators. If the ethernet port on the device is touched or manipulated, there is a risk of electrical shock

FDAJun 16, 2022Nationwide• Fresenius Medical Care Holdings, Inc.

Fresenius Medical Care Holdings, Inc.: AquaC UNO H [120V, 60Hz, 1000VA, Fresenius US-Version: ...

FDAJun 16, 2022Nationwide• Fresenius Medical Care Holdings, Inc.

Fresenius Medical Care Holdings, Inc.: NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal, Model No. 08-2301-3

The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging. Leaks can lead to biological contamination and therefore an increased risk of potential bloodstream infection.

FDAJun 1, 2022Nationwide• Fresenius Medical Care Holdings, Inc.

Fresenius Medical Care Holdings, Inc.: NATURALYTE Liquid Acid 3.0K 3.0Ca- indicated for use in p...

Alternate Bottle Caps labeled with "Sealed for your Protection" on the foil not qualified for use

FDAMay 31, 2022Nationwide• Fresenius Medical Care Holdings, Inc.

Fresenius Medical Care Holdings, Inc.: NATURALYTE Liquid Acid 2.0K 2.5Ca- indicated for use in p...

Alternate Bottle Caps labeled with "Sealed for your Protection" on the foil not qualified for use

FDAMay 31, 2022Nationwide• Fresenius Medical Care Holdings, Inc.

Fresenius Medical Care Holdings, Inc.: Optiflux 200NRe Dialyzer Finished Assy., Model no. 0500320E

Dialyzers were distributed after being exposed to cold temperatures which exceeded the low-temperature range in the firm's standard operating procedure.

FDAMay 4, 2022Nationwide• Fresenius Medical Care Holdings, Inc.

Fresenius Medical Care Holdings, Inc.: Novalung Sensor Box (F30000163) a component of Novalung C...

Error messages 206 (yellow) and 208 (red) technical failure, flow measurement during use of the Novalung System imply that the communication between flow sensor and sensor box is interrupted. An interrupted communication between flow sensor and sensor box might lead to a disabled flow measurement and air bubble detection.

FDADec 7, 2021Nationwide• Fresenius Medical Care Holdings, Inc.

Fresenius Medical Care Holdings, Inc.: AquaBplus Water Purification System, Part Number 24-2000-...

AquaBplus HF module on the AquaBplus 2000 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 2000 device. The 3-ring main and fluid fly loops the heat disinfection may not be as effective as a 2-ring main installation

FDAAug 3, 2021Nationwide• Fresenius Medical Care Holdings, Inc.