Nxstage Medical recalls
Nxstage Medical appears in 31 official U.S. recall notices indexed by RecallRadar, most recently on 2025-06-04.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 31 |
|---|---|
| Published | 2013-05-08 to 2025-06-04 |
| By agency | FDA Device (31) |
| By classification | Class II (31) |
| By status | terminated (29), ongoing (2) |
| Distribution named in notices | AL, AR, AZ, CA, ID, NC, NY, TX, US, VA |
Recalls
- NxStage PureFlow-B Solution
FDA Device · Class II · 2025-06-04 · Nxstage Medical
Reason: Potential for the perimeter seal on the small chamber of the two-chamber bag to fail causing the electrolyte fluid to splash into the face of the user when attempting to open the peel seam to mix the two chambers prior… - NxStage PureFlow-B Solution, Premixed Dialysate for Hemodialysis, Device Catalog Numbers RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-4…
FDA Device · Class II · 2024-06-26 · Nxstage Medical
Reason: The smaller chamber of the two chamber bag is bursting when nurses are attempting to mix the two chambers prior to use. The electrolyte fluid in the small chamber of the NxStage PureFlow B Solution has a pH of less than… - Low Volume Cartridge IFU (SKU CAR-125-B) used with the following devices: 1) NxStage One, Model NX1000-1
FDA Device · Class II · 2019-12-25 · Nxstage Medical
Reason: There is a potential patient health risk while performing chronic hemodialysis treatments in the home setting with for patients with low blood volume (2.4 Liters or less in a patient with body weight of 30kg or less) wh… - NxStage PureFlow B Solution, REF RFP-400, M535RFP4000 Product NxStage PureFlow B Solution is indicated for use with renal replacement thera…
FDA Device · Class II · 2019-06-12 · Nxstage Medical
Reason: Certain lots were mislabeled with incorrect product number. - NxStage PureFlow B Solution, REF RFP-401, M535RPF4010 NxStage PureFlow B Solution is indicated for use with renal replacement therapy syste…
FDA Device · Class II · 2019-06-12 · Nxstage Medical
Reason: Certain lots were mislabeled with incorrect product number. - NxStage PureFlow B Solution-RFP-RFP-454, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal re…
FDA Device · Class II · 2018-12-05 · Nxstage Medical
Reason: PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin - NxStage PureFlow B Solution-RFP-404, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replac…
FDA Device · Class II · 2018-12-05 · Nxstage Medical
Reason: PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin - NxStage PureFlow B Solution-RFP-402, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replac…
FDA Device · Class II · 2018-12-05 · Nxstage Medical
Reason: PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin - NxStage PureFlow B Solution-RFP-401, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replac…
FDA Device · Class II · 2018-12-05 · Nxstage Medical
Reason: PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin - NxStage PureFlow B Solution-RFP-403, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replac…
FDA Device · Class II · 2018-12-05 · Nxstage Medical
Reason: PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin - NxStage PureFlow B Solution-RFP-400, Premixed Dialysate for Hemodialysis
FDA Device · Class II · 2018-12-05 · Nxstage Medical
Reason: PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin - NxStage PureFlow B Solution-RFP-RFP-456, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal re…
FDA Device · Class II · 2018-12-05 · Nxstage Medical
Reason: PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin - NxStage PureFlow B Solution-RFP-406, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replac…
FDA Device · Class II · 2018-12-05 · Nxstage Medical
Reason: PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin - 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 accessor…
FDA Device · Class II · 2018-08-22 · Nxstage Medical
Reason: There is a potential risk of electrical fire when fluid leaks into the power receptacle on the back of the warmer. The risk exists any time the warmer is plugged in. The firm has received 7 reports of smoke, sparks, or… - NxStage PureFlow B Solution - Premixed Dialysate for Hemodialysis with NxStage System One
FDA Device · Class II · 2018-03-28 · Nxstage Medical
Reason: Using different fluid formulations of NxStage PureFlow B Solution at the same time during treatment may cause patient health risk. The NxStage PureFlow B Solution is for use with systems that use one premixed dialysate… - 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-…
FDA Device · Class II · 2018-03-07 · Nxstage Medical
Reason: May contain endotoxin levels which have been confirmed to exceed the ANSI/AAMI quality standard dialysis fluid of 0.5 EU/ml when used to prepare product. - NxStage System One S Cycler - Model no
FDA Device · Class II · 2015-12-02 · Nxstage Medical
Reason: Ultrafiltration Volume (UFV) may not decrease during treatment-software error. The UF pump may continue to run and remove fluid even after the target UF volume has been removed - NxStage System One S Cycler - Model no
FDA Device · Class II · 2015-12-02 · Nxstage Medical
Reason: Ultrafiltration Volume (UFV) may not decrease during treatment-software error. The UF pump may continue to run and remove fluid even after the target UF volume has been removed - NxStage System One S Cycler -High Permeability Hemodialysis System Model no
FDA Device · Class II · 2015-12-02 · Nxstage Medical
Reason: Ultrafiltration Volume (UFV) may not decrease during treatment-software error. The UF pump may continue to run and remove fluid even after the target UF volume has been removed - NxStage System One S Cycler (High Permeability Hemodialysis System) Model no
FDA Device · Class II · 2015-12-02 · Nxstage Medical
Reason: Ultrafiltration (UF) Volume software error inaccurate fluid removal - NxStage System One S Cycler (High Permeability Hemodialysis System) Model no
FDA Device · Class II · 2015-12-02 · Nxstage Medical
Reason: Ultrafiltration (UF) Volume software error inaccurate fluid removal - NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-303 Lactate 45, Potassium 1, Sodium 140, Calcium 3, Magnesi…
FDA Device · Class II · 2014-07-02 · Nxstage Medical
Reason: SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification - NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-407 Lactate 40, Potassium 1, Sodium 140, Calcium 3, Magnesi…
FDA Device · Class II · 2014-07-02 · Nxstage Medical
Reason: SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification - NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-306 Lactate 45, Potassium 2, Sodium 140, Calcium 3, Magnesi…
FDA Device · Class II · 2014-07-02 · Nxstage Medical
Reason: SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification - NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-307 Lactate 40, Potassium 1, Sodium 140, Calcium 3, Magnesi…
FDA Device · Class II · 2014-07-02 · Nxstage Medical
Reason: SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification - NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-304 Lactate 45, Potassium 2, Sodium 140, Calcium 3,Magnesiu…
FDA Device · Class II · 2014-07-02 · Nxstage Medical
Reason: SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification - NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-305 Lactate 45, Potassium 1, Sodium 140, Calcium 3, Magnesi…
FDA Device · Class II · 2014-07-02 · Nxstage Medical
Reason: SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification - NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-302 Lactate , 40, Potassium 1, Sodium 140, Calcium 3, Magne…
FDA Device · Class II · 2014-07-02 · Nxstage Medical
Reason: SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification - NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-301 Lactate 45, Potassium 1, Sodium 140, Calcium 3, Magnesi…
FDA Device · Class II · 2014-07-02 · Nxstage Medical
Reason: SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification - NxStage PureFlow-B Solution
FDA Device · Class II · 2014-03-05 · Nxstage Medical
Reason: Mislabeled product. - NxStage PureFlow-B Solution, Model/Catalog Number: RFP-401, packaged in a case The NxStage PureFLow-B Solution is indicated for use with re…
FDA Device · Class II · 2013-05-08 · Nxstage Medical
Reason: Product may be mislabeled.