RegWardenFDA facility compliance records
Facility

Fresenius USA Manufacturing, Inc.

21 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2015: 2 recalls; 2016: 5 recalls; 2017: 3 recalls, 1 inspections; 2018: 5 recalls; 2019: 2 recalls; 2026: 4 recalls, 1 inspections220155201642017520182201920202021202220232024202552026
  • Recalls (21)
  • Inspections (2)

Devices registered here (1)

  • Dialyzer, High Permeability With Or Without Sealed Dialysate System
    Product code KDI (opens in a new tab) · Class II · Gastroenterology, Urology · 21 CFR 876.5860

Recalls & enforcement

20264 records
  • Class IIOngoing2026-08-10
    Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia.
  • Class IIOngoing2026-07-29
    Communication to recommend reviewing the IFU and ensuring that all treatment preparation and handling steps are performed as instructed.
  • Class IIOngoing2026-07-14
    Complaints of blue-green discoloration in product
  • Class IIOngoing2026-06-30
    Fresenius Medical Care Renal Therapies Group, LLC (FMCRTG) has received complaints regarding flow-, no water-, or temperature-related alarms with the 2008T® BlueStar Hemodialysis machines.
20192 records
  • Class IITerminated2019-05-29
    Additional Instructions: step-by step handling and inserting the cassette into the Liberty Cycler set. A damaged cassette can cause peritoneal dialysis (PD) solution to leak into the cycler and is a potential risk for contamination.
  • Class IIITerminated2019-04-03
    Power Logic Board Fail Message on the 2008T BlueStar Machine with software version 2.72.
20185 records
  • Class IITerminated2018-11-05
    Potential for external blood leaks from the dialyzer header
  • Class IIITerminated2018-10-09
    Discolored powder has confirmed the presence of a foreign substance
  • Class IITerminated2018-07-13
    In the hemodialysis machine during the cleaning/disinfection program, when there is a power failure or interruption, the dialysis program button should be greyed out when the machine is powered up and a mandatory rinse should be required. However, if a power failure or interrupti…
  • Class IITerminated2018-05-02
    The bottles are mislabeled with an incorrect part number.
  • Class IITerminated2018-01-24
    The recalling firm identified a software issue related to the Patient Line Check (PLC) which may result in an increased risk of Overfill (also known as Increased Intraperitoneal Volume, IIPV). Overfill/IIPV may result in serious injury or death.
20173 records
  • Class IITerminated2017-12-14
    When the recirculation ultrafiltration (UF) Goal is set to a value greater than 200ml in service mode and the user starts a treatment using the SLED (Sustained Low Efficiency Dialysis) program the display will show an invalid message and the UF pump will run at the recirculation …
  • Class IITerminated2017-10-05
    While reviewing documentation for the next software release of the 2008T, an R&D technician identified that setting the UF goal to '0' introduces a discrepancy between the UF rate displayed and the actual UF pump rate. The software anomaly is also applicable to the 2008T Machines…
  • Class IITerminated2017-09-29
    The label specifies the potassium concentration is 2.0 mEq/L. Some of the product in the affected lot was found to have a potassium concentration of 2.25 mEq/L.
20165 records
  • Class IITerminated2016-12-21
    When the UF Rate, Goal or Time is adjusted using the up and down arrow keys, and the change is cancelled by using the esc key, the cancelled UF Rate is actually being executed rather than rate displayed on the machine
  • Class IITerminated2016-05-24
    Use of the Blood Pressure Graph located on the Crit-Line screen of the 2008T Hemodialysis Machine may result in a frozen screen, possibly causing the blood pump to stop.
  • Class IITerminated2016-03-10
    Added Warning Statement: Fresenius 2008 Series Hemodialysis Machines False Blood Leak Alarm When Dialyzing Patients Treated with Hydroxocobalamin (or any form of Vitamin B-12)
  • Class IITerminated2016-02-26
    Dialyzer header leak due to possible improper torque
  • Class IITerminated2016-01-18
    On the label calcium (Ca) listed in the right upper corner of the label (red background) incorrectly indicates the product contains 2.5 mEq/L Ca. The concentration indicated in the list of constituents represents the actual calcium concentration of the final dialysate, 3.0 mEq/L…
20152 records
  • Class IITerminated2015-12-15
    The door latch may not fully close and the door may open unexpectedly. The door may make physical contact with anything near the door of the machine, including the patient. May cause injury, delay in treatment, or Increased Intraperitoneal Volume (IIPV) (overfill).
  • Class IITerminated2015-10-23
    Dissolution units and replacement motors units do not provide full thermal protection for both the Main and Starter coils resulting in the generation of smoke and/or potentially lead to fire.

FDA inspections (2)

  • NAI2026-07-24
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
  • NAI2017-05-18
    No Action Indicated · Compliance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Fresenius USA Manufacturing, Inc. (FEI 1713747) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1713747-fresenius-usa-manufacturing-inc/

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