The Recall Desk

Manufacturer

NxStage Medical, Inc.

31 recalls in our database name NxStage Medical, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
31
Critical
0
Severe
7
Most recent
2025-06-04

Of the 31 recalls from NxStage Medical, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 7 (23%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 31

  • HighFDA (Devices)·Z-1864-2025·2025-06-04

    NxStage PureFlow-B Solution Bags Perimeter Seal Failure Risk

    NxStage Medical Inc is recalling NxStage PureFlow-B Solution bags nationwide due to potential perimeter seal failure on the small chamber, which could cause electrolyte fluid to splash into the user's face when opening the peel seam to mix chambers before treatment.

    Product
    NxStage PureFlow-B Solution. Catalog numbers: RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-406, RFP-453, RFP-454, RFP-456.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2160-2024·2024-06-26

    NxStage PureFlow-B Hemodialysis Solution Bags Recalled Due to Bursting Chambers and Caustic Fluid

    NxStage PureFlow-B hemodialysis solution bags may burst during preparation, releasing caustic electrolyte fluid that can cause chemical burns. Affected units are distributed nationwide.

    Product
    NxStage PureFlow-B Solution, Premixed Dialysate for Hemodialysis, Device Catalog Numbers RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-405, RFP-406, RFP-453, RFP-454, RFP-456
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0697-2020·2019-12-25

    NxStage Low Volume Cartridge Recalled for Hemodialysis Risk

    NxStage Medical is recalling Low Volume Cartridge IFUs due to a potential health risk for low-volume patients using larger dialysate volumes.

    Product
    Low Volume Cartridge IFU (SKU CAR-125-B) used with the following devices: 1) NxStage One, Model NX1000-1; 2) NxStage VersiHD Cycler, Model Numbers: NX1000-16, and NX1000-16-A; 3) NxStage One, Model Numbers: NX1000-3 and NX1000-3-A; 4) NxStage One, Model Numbers: NX1000-10 a
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1706-2019·2019-06-12

    NxStage PureFlow B Solution Recalled for Incorrect Product Number Labeling

    NxStage Medical is recalling 1,998 units of PureFlow B Solution because certain lots were mislabeled with the incorrect product number.

    Product
    NxStage PureFlow B Solution, REF RFP-400, M535RFP4000 Product NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1707-2019·2019-06-12

    NxStage PureFlow B Solution Recalled for Incorrect Product Number Labeling

    NxStage Medical is recalling specific lots of PureFlow B Solution because they were mislabeled with the incorrect product number.

    Product
    NxStage PureFlow B Solution, REF RFP-401, M535RPF4010 NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0505-2019·2018-12-05

    NxStage PureFlow B Solution Recalled for Potential Bag Bursting

    NxStage Medical is recalling PureFlow B Solution because the bag's smaller chamber may burst, releasing electrolyte fluid that can injure eyes or skin.

    Product
    NxStage PureFlow B Solution-RFP-406, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0502-2019·2018-12-05

    NxStage PureFlow B Solution Recalled for Potential Bag Bursting and Injury

    NxStage Medical is recalling specific lots of PureFlow B Solution because the smaller chamber of the two-chamber bag can burst, releasing electrolyte fluid that may cause injury if it contacts eyes or skin.

    Product
    NxStage PureFlow B Solution-RFP-402, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0506-2019·2018-12-05

    NxStage PureFlow B Solution Recalled Due to Bag Bursting Risk

    NxStage Medical is recalling 7,275 units of PureFlow B Solution because the bag's smaller chamber may burst, releasing electrolyte fluid that can injure eyes or skin.

    Product
    NxStage PureFlow B Solution-RFP-RFP-454, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0507-2019·2018-12-05

    NxStage PureFlow B Solution Recalled for Potential Bag Bursting Hazard

    NxStage Medical is recalling PureFlow B Solution because the smaller chamber of the bag can burst, releasing electrolyte fluid that may cause injury if it contacts eyes or skin.

    Product
    NxStage PureFlow B Solution-RFP-RFP-456, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0504-2019·2018-12-05

    NxStage PureFlow B Solution Recalled for Potential Bag Burst Injury Risk

    NxStage Medical is recalling PureFlow B Solution because the smaller chamber of the two-chamber bag can burst, releasing electrolyte fluid that may cause injury if it contacts eyes or skin.

    Product
    NxStage PureFlow B Solution-RFP-404, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0500-2019·2018-12-05

    NxStage PureFlow B Solution Recalled for Potential Bag Bursting

    NxStage Medical is recalling 59,100 units of PureFlow B Solution because the smaller chamber may burst, releasing electrolyte fluid that can injure eyes or skin.

    Product
    NxStage PureFlow B Solution-RFP-400, Premixed Dialysate for Hemodialysis. NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0501-2019·2018-12-05

    NxStage PureFlow B Solution Recalled Due to Bag Burst Risk

    NxStage Medical is recalling PureFlow B Solution because the smaller chamber of the two-chamber bag can burst, releasing electrolyte fluid that may injure eyes or skin.

    Product
    NxStage PureFlow B Solution-RFP-401, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0503-2019·2018-12-05

    NxStage PureFlow B Solution Recalled Due to Bag Burst Risk

    NxStage Medical is recalling 2,189 units of PureFlow B Solution because the bag's smaller chamber can burst, releasing electrolyte fluid that may injure eyes or skin.

    Product
    NxStage PureFlow B Solution-RFP-403, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2793-2018·2018-08-22

    NxStage Express Fluid Warmer Recalled for Electrical Fire Risk

    NxStage Medical is recalling Express Fluid Warmers due to a potential risk of electrical fire if fluid leaks into the power receptacle.

    Product
    NxStage Express Fluid Warmer (FW-300, FW-300-A, FW-300-WW, FW-301, FW-301-A) Product Usage: The NxStage Express Fluid Warmer is an accessory to the NxStage System One used to warm therapy fluids prior to administration.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1132-2018·2018-03-28

    NxStage PureFlow B Solution Recalled for Missing Labeling Warnings

    NxStage Medical is recalling 1,243,400 units of PureFlow B Solution because the original labeling failed to warn against mixing dialysate formulations.

    Product
    NxStage PureFlow B Solution - Premixed Dialysate for Hemodialysis with NxStage System One
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0811-2018·2018-03-07

    NxStage Dialysate Sacks Recalled for Exceeding Endotoxin Quality Standards

    NxStage Medical is recalling dialysate sacks because endotoxin levels may exceed the ANSI/AAMI quality standard of 0.5 EU/ml.

    Product
    NxStage Dialysate Sack: 1) REF SAK-301 UDI-M535SAK3010, 2) REF SAK-302 UDI-M535SAK3020, 3) REF SAK-303 UDI-M535SAK3030, 4) REF SAK-304 UDI-M535SAK3040, 5) REF SAK-306 UDI-M535SAK3060, 6) REF SAK-307 UDI- M535SAK3070, 6) REF SAK-402 UDI-M535SAK4020, 7) REF SAK-405 UDI- M535SAK4050
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0337-2016·2015-12-02

    NxStage Hemodialysis System Recalled for Ultrafiltration Volume Software Error

    NxStage Medical is recalling 7 units of the System One S Cycler hemodialysis system due to a software error that may cause the pump to continue removing fluid after the target volume is reached.

    Product
    NxStage System One S Cycler -High Permeability Hemodialysis System Model no. NX1000-4
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0335-2016·2015-12-02

    NxStage System One S Cycler Recalled for Ultrafiltration Software Error

    NxStage Medical is recalling 2,134 System One S Cycler units due to a software error that may cause the pump to continue removing fluid after the target volume is reached.

    Product
    NxStage System One S Cycler - Model no. NX1000-3. For home hemodialysis.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0326-2016·2015-12-02

    NxStage System One S Cycler Recalled for Ultrafiltration Software Error

    NxStage Medical is recalling 323 System One S Cycler units due to a software error that may cause inaccurate fluid removal during hemodialysis.

    Product
    NxStage System One S Cycler (High Permeability Hemodialysis System) Model no. NX1000-5
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0327-2016·2015-12-02

    NxStage System One S Cycler Recalled for Ultrafiltration Software Error

    NxStage Medical is recalling 16 System One S Cycler units due to a software error causing inaccurate fluid removal.

    Product
    NxStage System One S Cycler (High Permeability Hemodialysis System) Model no. NX1000-5-A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0336-2016·2015-12-02

    NxStage System One S Cycler Recalled for Ultrafiltration Software Error

    NxStage Medical is recalling 133 System One S Cycler units due to a software error that may cause the pump to continue removing fluid after the target volume is reached.

    Product
    NxStage System One S Cycler - Model no. NX1000-3-A (OUS). For home hemodialysis.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1854-2014·2014-07-02

    NxStage Dialysate Sacks Recalled for Excess Aluminum Levels

    NxStage Medical is recalling dialysate sacks used with the PureFlow SL system because they contain aluminum levels exceeding internal specifications.

    Product
    NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-301 Lactate 45, Potassium 1, Sodium 140, Calcium 3, Magnesium 1, Chloride 100, Glucose (mg/dL) 100 Batch Size (liters) 60 The SAK is one of the disposables used with NxStage PureFlow SL Dialy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1859-2014·2014-07-02

    NxStage Dialysate Sacks Recalled for Excess Aluminum Levels

    NxStage Medical is recalling 2,711 cases of dialysate sacks because aluminum levels exceeded internal specifications.

    Product
    NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-306 Lactate 45, Potassium 2, Sodium 140, Calcium 3, Magnesium 1, Chloride 101, Glucose (mg/dL) 100 Batch Size (liters) 50 The SAK is one of the disposables used with NxStage PureFlow SL Dialy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1857-2014·2014-07-02

    NxStage Dialysate Sacks Recalled for Excess Aluminum Levels

    NxStage Medical is recalling dialysate sacks with concentrate due to aluminum levels exceeding internal product specifications.

    Product
    NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-304 Lactate 45, Potassium 2, Sodium 140, Calcium 3,Magnesium 1, Chloride 101, Glucose (mg/dL) 100 Batch Size (liters) 60 The SAK is one of the disposables used with NxStage PureFlow SL Dialys
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1858-2014·2014-07-02

    NxStage Dialysate Sacks Recalled for Excess Aluminum Levels

    NxStage Medical is recalling dialysate sacks with concentrate due to aluminum levels exceeding internal product specifications.

    Product
    NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-305 Lactate 45, Potassium 1, Sodium 140, Calcium 3, Magnesium 1 Chloride 100, Glucose (mg/dL) 100 Batch Size (liters) 40
    Category
    Medical Device
    Distribution
    Distributed nationwide