FDA device enforcement
2008T HD SYS. CDX W/BIBAG BLUESTAR
Potential PCBA leaching from tubing of hemodialysis machines.
Class IReported ongoing
Distribution: Domestic: Nationwide Distribution.
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Fresenius Medical Care Holdings, Inc. recall records
57 reported ongoing
60 records in this archive. Latest source date May 12, 2026.
FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
Records and reported status
Official source for 2008T HD SYS. CDX W/BIBAG BLUESTAR
FDA device enforcement
2008T HD SYS. W/O CDX BLUESTAR
Potential PCBA leaching from tubing of hemodialysis machines.
Class IReported ongoing
Distribution: Domestic: Nationwide Distribution.
FDA device enforcement
2008T HD SYS. W/O CDX W/BIBAG BLUESTAR
Potential PCBA leaching from tubing of hemodialysis machines.
Class IReported ongoing
Distribution: Domestic: Nationwide Distribution.
FDA device enforcement
10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
There is a potential for blood backfill leakage and foreign material.
Class IReported ongoing
Distribution: US Nationwide.
FDA device enforcement
10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case
There is a potential for blood backfill leakage and foreign material.
Class IReported ongoing
Distribution: US Nationwide.
FDA device enforcement
3ML Syringe Luer Lock with needle 20GX1, Part Number 15-03ML-0, 100 per box, 24 boxes per case
There is a potential for blood backfill leakage and foreign material.
Class IReported ongoing
Distribution: US Nationwide.
FDA drug enforcement
Sodium Chloride 0.9% Injection, USP, 1000 mL bags, 12 bags per carton, Rx only, Fresenius Medical Care North America, Waltham, MA 02451, NDC # 49230-300-10
Lack of assurance of sterility: The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging.
Class IIReported terminated
Distribution: Product was distributed to 32 clinics in SC, NC and VA.
FDA drug enforcement
0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs, 1000mL Bag, 12 PK, Rx Only, Fresenius Medical Care North...
Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.
Class IIReported ongoing
Distribution: Product was distributed Nationwide in the USA.
FDA drug enforcement
0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs, 1000mL Bag, 12 PK, Rx Only, Fresenius Medical Care North...
Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.
Class IIReported ongoing
Distribution: Nationwide in the USA
FDA device enforcement
NaturaLyte Liquid Acid concentrate, Part Number 08-0231-4, four (4) one-gallon bottles per bottle case. For dialysis.
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.
Class IIReported ongoing
Distribution: Domestic distribution to AL AZ CA DC FL GA HI IL IN MD MI MO MS NE NJ NY OH PA SD TX VA No foreign distribution.
FDA device enforcement
2008T and 2008TBluestar Hemodialysis Machines with CDX-Indicated for acute and chronic dialysis therapy in a healthcare facility Models: (1) 190713 2008T HEMODIALYSIS SYS., with...
(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".
Class IIReported ongoing
Distribution: US Nationwide distribution.
FDA device enforcement
AquaC UNO H [120V, 60Hz, 1000VA, US-Version - a reverse osmosis unit intended for use with hemodialysis systems. Fresenius Part Number: 24-10VA-1 Vivonic Part Number: G02000970-US
Internal ethemet cables are missing one or both ferrite cores therefore the electromagnetic compatibility of the device is not ensured
Class IIReported ongoing
Distribution: US Nationwide distribution in the states of AZ, CA, DC, FL, GA, IN, MA, NV, NY, PA, TX.
FDA device enforcement
AquaC UNO H [120V, 60Hz, 1700VA, US-Version- a reverse osmosis unit intended for use with hemodialysis systems. Fresenius Part Number: 24-0970-1 Vivonic Part Number: G02000966-US
Internal ethemet cables are missing one or both ferrite cores therefore the electromagnetic compatibility of the device is not ensured
Class IIReported ongoing
Distribution: US Nationwide distribution in the states of AZ, CA, DC, FL, GA, IN, MA, NV, NY, PA, TX.
FDA device enforcement
AquaC UNO H [120V, 60Hz, 1700VA, Fresenius US-Version: 24-0970-1 Vivonic Part Number: G02000966-US
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...
Class IIReported ongoing
Distribution: US Nationwide distribution.
FDA device enforcement
AquaC UNO H [120V, 60Hz, 1000VA, Fresenius US-Version: 24-10VA-1 Vivonic Part Number: G02000970-US
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...
Class IIReported ongoing
Distribution: US Nationwide distribution.
FDA device enforcement
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.
Class IIReported terminated
Distribution: US Nationwide distribution in the states of Texas and Louisiana.
FDA device enforcement
NATURALYTE Liquid Acid 2.0K 2.5Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure Part Number: 08-2251-0
Alternate Bottle Caps labeled with "Sealed for your Protection" on the foil not qualified for use
Class IIReported ongoing
Distribution: Natiowide
FDA device enforcement
NATURALYTE Liquid Acid 3.0K 3.0Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure Part Number: 08-3301-2
Alternate Bottle Caps labeled with "Sealed for your Protection" on the foil not qualified for use
Class IIReported ongoing
Distribution: Natiowide
FDA device enforcement
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.
Class IIReported terminated
Distribution: US Nationwide distribution in the state of Pennsylvania.
FDA device enforcement
Novalung Sensor Box (F30000163) a component of Novalung Console (F30000162)- Indicated for long-term (> 6 hours) respiratory/ cardiopulmonary support that provides assisted extr...
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 m...
Class IIReported ongoing
Distribution: US Nationwide distribution in the states of AL, AZ, CA, CO, FL, IL, MI, NJ, NV, NY, OK, OR, PA, TN, TX, WV.
Reasons in these listed records
- Potential PCBA leaching from tubing of hemodialysis machines.
- There is a potential for blood backfill leakage and foreign material.
- Lack of assurance of sterility: The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging.
- Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.
These examples come from this result page and are not a ranking of every recall reason.
Checking Fresenius Medical Care Holdings, Inc.
Is there a recall on fresenius medical care holdings, inc. right now?
This archive contains 60 records, including 57 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.
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