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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:
April 3, 2024Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls stay-safe /Luer Lock Adapter 4 in
Hazard: The peroxide cross-linked tubing has leachables identified as NDL PCBAs.
April 3, 2024Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls stay-safe /Safe Lock Catheter Ext. 12 in
Hazard: The peroxide cross-linked tubing has leachables identified as NDL PCBAs.
January 10, 2024DrugsFDA
Fresenius Medical Care Holdings, Inc. recalls DELFLEX Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose, packaged in 6000mL bags, Rx only, Fresenius Med
Hazard: Lack of Sterility Assurance
January 3, 2024Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls Liberty Select Cycler, Model numbers RTLR180343 and RTLR180111
Hazard: Affected Liberty Select cyclers may display an incorrect time stamp on the treatment data report sent to the clinic.
December 13, 2023Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls Stay Safe Cap
Hazard: Updating the labeling to include additional warnings and contraindications for potential side effects.
October 18, 2023Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls 2008T HD SYS. W/O CDX W/BIBAG BLUESTAR
Hazard: Potential PCBA leaching from tubing of hemodialysis machines.
October 18, 2023Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls 2008T HD SYS. W/O CDX BLUESTAR
Hazard: Potential PCBA leaching from tubing of hemodialysis machines.
October 18, 2023Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls 2008T HD SYS. CDX W/BIBAG BLUESTAR
Hazard: Potential PCBA leaching from tubing of hemodialysis machines.
October 18, 2023Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls 2008T HD SYS. CDX BLUESTAR
Hazard: Potential PCBA leaching from tubing of hemodialysis machines.
October 18, 2023Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls 2008T GEN 2 Bibag without CDX
Hazard: Potential PCBA leaching from tubing of hemodialysis machines.
October 18, 2023Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls 2008T Hemodialysis System w/Bibag
Hazard: Potential PCBA leaching from tubing of hemodialysis machines.
October 18, 2023Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls 2008T Hemodialysis System without CDX
Hazard: Potential PCBA leaching from tubing of hemodialysis machines.
October 18, 2023Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls 2008T Hemodialysis SYS, with CDX
Hazard: Potential PCBA leaching from tubing of hemodialysis machines.
October 18, 2023Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls 3ML Syringe Luer Lock with needle 20GX1, Part Number 15-03ML-0, 100 per box, 24 boxes per case
Hazard: There is a potential for blood backfill leakage and foreign material.
October 18, 2023Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls 10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case
Hazard: There is a potential for blood backfill leakage and foreign material.
October 18, 2023Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls 10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
Hazard: There is a potential for blood backfill leakage and foreign material.
June 7, 2023DrugsFDA
Fresenius Medical Care Holdings, Inc. recalls Sodium Chloride 0.9% Injection, USP, 1000 mL bags, 12 bags per carton, Rx only, Fresenius Medical Care North America, Wa
Hazard: Lack of assurance of sterility: The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging.
December 28, 2022Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls 2008T and 2008TBluestar Hemodialysis Machines with CDX-Indicated for acute and chronic dialysis therapy in a healthcare
Hazard: (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".
December 14, 2022DrugsFDA
Fresenius Medical Care Holdings, Inc. recalls 0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs,
Hazard: Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.
November 16, 2022Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls NaturaLyte Liquid Acid concentrate, Part Number 08-0231-4, four (4) one-gallon bottles per bottle case. For dialysis.
Hazard: 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.
October 26, 2022DrugsFDA
Fresenius Medical Care Holdings, Inc. recalls 0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs,
Hazard: Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.
September 28, 2022Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls AquaC UNO H [120V, 60Hz, 1700VA, US-Version- a reverse osmosis unit intended for use with hemodialysis systems. Fresen
Hazard: Internal ethemet cables are missing one or both ferrite cores therefore the electromagnetic compatibility of the device is not ensured
September 28, 2022Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls AquaC UNO H [120V, 60Hz, 1000VA, US-Version - a reverse osmosis unit intended for use with hemodialysis systems. Fre
Hazard: Internal ethemet cables are missing one or both ferrite cores therefore the electromagnetic compatibility of the device is not ensured
August 3, 2022Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls AquaC UNO H [120V, 60Hz, 1000VA, Fresenius US-Version: 24-10VA-1 Vivonic Part Number: G02000970-US
Hazard: 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
August 3, 2022Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls AquaC UNO H [120V, 60Hz, 1700VA, Fresenius US-Version: 24-0970-1 Vivonic Part Number: G02000966-US
Hazard: 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
July 20, 2022Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls NATURALYTE Liquid Acid 3.0K 3.0Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for
Hazard: Alternate Bottle Caps labeled with "Sealed for your Protection" on the foil not qualified for use
July 20, 2022Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls NATURALYTE Liquid Acid 2.0K 2.5Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for
Hazard: Alternate Bottle Caps labeled with "Sealed for your Protection" on the foil not qualified for use
July 20, 2022Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls AquaBplus Water Purification System, Part Number 24-2000-0, AquaBplus 2500 - Typ USA (G02040108-US), AquaBplus 2000 - Ty
Hazard: 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
July 13, 2022Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal, Model No. 08-2301-3
Hazard: 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.
July 6, 2022Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls Optiflux 200NRe Dialyzer Finished Assy., Model no. 0500320E
Hazard: Dialyzers were distributed after being exposed to cold temperatures which exceeded the low-temperature range in the firm's standard operating procedure.