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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

84

Past Year

4

Class I (Serious)

0

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 21–40 of 84 recalls

Stay-Safe Luer Catheter Extension (Fresenius) – Leachable Concerns (2024)

The peroxide cross-linked tubing has leachables identified as NDL PCBAs.

FDAJan 23, 2024Nationwide• Fresenius Medical Care Holdings, Inc.

Stay-Safe Luer Lock Adapter (Fresenius) – Leachable Concerns (2024)

The peroxide cross-linked tubing has leachables identified as NDL PCBAs.

FDAJan 23, 2024Nationwide• Fresenius Medical Care Holdings, Inc.

Stay-Safe Luer Lock Catheter Extension (Fresenius) – Leachable Concerns (2024)

The peroxide cross-linked tubing has leachables identified as NDL PCBAs.

FDAJan 23, 2024Nationwide

Page 2 of 5Next

• Fresenius Medical Care Holdings, Inc.

DELFLEX Peritoneal Dialysis Solution (Fresenius) – Sterility Concern (2023)

Lack of Sterility Assurance

Class IIModerate

FDADec 28, 2023Nationwide• Fresenius Medical Care Holdings, Inc.

Fresenius Medical Care Holdings, Inc.: Liberty Select Cycler, Model numbers RTLR180343 and RTLR1...

Affected Liberty Select cyclers may display an incorrect time stamp on the treatment data report sent to the clinic.

FDAOct 24, 2023Nationwide• Fresenius Medical Care Holdings, Inc.

Fresenius Medical Care Holdings, Inc.: Stay Safe Cap

Updating the labeling to include additional warnings and contraindications for potential side effects.

FDAOct 10, 2023Nationwide• Fresenius Medical Care Holdings, Inc.

Fresenius Medical Care Holdings, Inc.: 2008T GEN 2 Bibag without CDX

Potential PCBA leaching from tubing of hemodialysis machines.

FDASep 6, 2023Nationwide• Fresenius Medical Care Holdings, Inc.

Fresenius Medical Care Holdings, Inc.: 2008T HD SYS. CDX BLUESTAR

Potential PCBA leaching from tubing of hemodialysis machines.

FDASep 6, 2023Nationwide• Fresenius Medical Care Holdings, Inc.

Fresenius Medical Care Holdings, Inc.: 2008T Hemodialysis System without CDX

Potential PCBA leaching from tubing of hemodialysis machines.

FDASep 6, 2023Nationwide• Fresenius Medical Care Holdings, Inc.

Fresenius Medical Care Holdings, Inc.: 2008T Hemodialysis SYS, with CDX

Potential PCBA leaching from tubing of hemodialysis machines.

FDASep 6, 2023Nationwide• Fresenius Medical Care Holdings, Inc.

Fresenius Medical Care Holdings, Inc.: 2008T HD SYS. CDX W/BIBAG BLUESTAR

Potential PCBA leaching from tubing of hemodialysis machines.

FDASep 6, 2023Nationwide• Fresenius Medical Care Holdings, Inc.

Fresenius Medical Care Holdings, Inc.: 2008T HD SYS. W/O CDX W/BIBAG BLUESTAR

Potential PCBA leaching from tubing of hemodialysis machines.

FDASep 6, 2023Nationwide• Fresenius Medical Care Holdings, Inc.

Fresenius Medical Care Holdings, Inc.: 2008T Hemodialysis System w/Bibag

Potential PCBA leaching from tubing of hemodialysis machines.

FDASep 6, 2023Nationwide• Fresenius Medical Care Holdings, Inc.

Fresenius Medical Care Holdings, Inc.: 2008T HD SYS. W/O CDX BLUESTAR

Potential PCBA leaching from tubing of hemodialysis machines.

FDASep 6, 2023Nationwide• Fresenius Medical Care Holdings, Inc.

Fresenius Medical Care Holdings, Inc.: 10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 1...

There is a potential for blood backfill leakage and foreign material.

FDAAug 8, 2023Nationwide• Fresenius Medical Care Holdings, Inc.

Fresenius Medical Care Holdings, Inc.: 3ML Syringe Luer Lock with needle 20GX1, Part Number 15-0...

There is a potential for blood backfill leakage and foreign material.

FDAAug 8, 2023Nationwide• Fresenius Medical Care Holdings, Inc.

Fresenius Medical Care Holdings, Inc.: 10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-...

There is a potential for blood backfill leakage and foreign material.

FDAAug 8, 2023Nationwide• Fresenius Medical Care Holdings, Inc.

Sodium Chloride Injection (Fresenius) – Storage Temperature Risk (2023)

Lack of assurance of sterility: The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging.

Class IIModerate

FDAMay 23, 2023IN, NC, SC +1 more• Fresenius Medical Care Holdings, Inc.

Sodium Chloride Injection (Fresenius) – Sterility Concern (2022)

Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.

Class IIModerate

FDANov 22, 2022Nationwide• Fresenius Medical Care Holdings, Inc.

Sodium Chloride Injection (Fresenius) – Sterility Concern (2022)

Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.

Class IIModerate

FDAOct 11, 2022Nationwide• Fresenius Medical Care Holdings, Inc.