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.
- NxStage PureFlow-B Solution
FDA Device · Class II · 2025-06-04 · Nxstage Medical - 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 - 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 - 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 - 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 - 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 - 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 - 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 - 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 - 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 - NxStage PureFlow B Solution-RFP-400, Premixed Dialysate for Hemodialysis
FDA Device · Class II · 2018-12-05 · Nxstage Medical - 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 - 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 - 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 - NxStage PureFlow B Solution - Premixed Dialysate for Hemodialysis with NxStage System One
FDA Device · Class II · 2018-03-28 · Nxstage Medical - 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 - NxStage System One S Cycler - Model no
FDA Device · Class II · 2015-12-02 · Nxstage Medical - NxStage System One S Cycler - Model no
FDA Device · Class II · 2015-12-02 · Nxstage Medical - NxStage System One S Cycler -High Permeability Hemodialysis System Model no
FDA Device · Class II · 2015-12-02 · Nxstage Medical - NxStage System One S Cycler (High Permeability Hemodialysis System) Model no
FDA Device · Class II · 2015-12-02 · Nxstage Medical - NxStage System One S Cycler (High Permeability Hemodialysis System) Model no
FDA Device · Class II · 2015-12-02 · Nxstage Medical - 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 - 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 - 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 - 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 - 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 - 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 - 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 - 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 - NxStage PureFlow-B Solution
FDA Device · Class II · 2014-03-05 · Nxstage Medical - 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