Nxstage Medical, Inc.
Lawrence, MA
This page shows every FDA and USDA recall linked to Nxstage Medical, Inc.. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
36
Total Recalls
2004
First Recall
2025
Most Recent
NxStage PureFlow-B Solution. Catalog numbers: RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-406, RFP-453, R...
May 28, 2025
· Device
Open, Classified
NxStage PureFlow-B Solution, Premixed Dialysate for Hemodialysis, Device Catalog Numbers RFP-400, RFP-401, RFP...
Jun 20, 2024
· Device
Open, Classified
Low Volume Cartridge IFU (SKU CAR-125-B) used with the following devices:
1) NxStage One, Model NX1000-1;
2)...
Aug 27, 2019
· Device
Terminated
NxStage PureFlow B Solution, REF RFP-401, M535RPF4010
NxStage PureFlow B Solution is indicated for use with r...
Apr 11, 2019
· Device
Terminated
NxStage PureFlow B Solution, REF RFP-400, M535RFP4000
Product NxStage PureFlow B Solution is indicated for us...
Apr 11, 2019
· Device
Terminated
NxStage PureFlow B Solution-RFP-403, Premixed Dialysate for Hemodialysis
NxStage PureFlow B Solution is ind...
Oct 17, 2018
· Device
Terminated
NxStage PureFlow B Solution-RFP-406, Premixed Dialysate for Hemodialysis
NxStage PureFlow B Solution is indi...
Oct 17, 2018
· Device
Terminated
NxStage PureFlow B Solution-RFP-400, Premixed Dialysate for Hemodialysis.
NxStage PureFlow B Solution is in...
Oct 17, 2018
· Device
Terminated
NxStage PureFlow B Solution-RFP-RFP-456, Premixed Dialysate for Hemodialysis
NxStage PureFlow B Solution is...
Oct 17, 2018
· Device
Terminated
NxStage PureFlow B Solution-RFP-404, Premixed Dialysate for Hemodialysis
NxStage PureFlow B Solution is indi...
Oct 17, 2018
· Device
Terminated
NxStage PureFlow B Solution-RFP-401, Premixed Dialysate for Hemodialysis
NxStage PureFlow B Solution is indi...
Oct 17, 2018
· Device
Terminated
NxStage PureFlow B Solution-RFP-RFP-454, Premixed Dialysate for Hemodialysis
NxStage PureFlow B Solution is...
Oct 17, 2018
· Device
Terminated
NxStage PureFlow B Solution-RFP-402, Premixed Dialysate for Hemodialysis
NxStage PureFlow B Solution is indi...
Oct 17, 2018
· Device
Terminated
NxStage Express Fluid Warmer (FW-300, FW-300-A, FW-300-WW, FW-301, FW-301-A)
Product Usage:
The NxStage Expre...
Jun 11, 2018
· Device
Terminated
NxStage Dialysate Sack: 1) REF SAK-301 UDI-M535SAK3010, 2) REF SAK-302 UDI-M535SAK3020, 3) REF SAK-303 UDI-M53...
Jan 29, 2018
· Device
Terminated
NxStage PureFlow B Solution - Premixed Dialysate for Hemodialysis with NxStage System One
Nov 10, 2017
· Device
Terminated
NxStage System One S Cycler - Model no. NX1000-3.
For home hemodialysis.
Oct 29, 2015
· Device
Terminated
NxStage System One S Cycler (High Permeability Hemodialysis System)
Model no. NX1000-5
Oct 29, 2015
· Device
Terminated
NxStage System One S Cycler -High Permeability Hemodialysis System
Model no. NX1000-4
Oct 29, 2015
· Device
Terminated
NxStage System One S Cycler - Model no. NX1000-3-A (OUS).
For home hemodialysis.
Oct 29, 2015
· Device
Terminated
NxStage System One S Cycler (High Permeability Hemodialysis System)
Model no. NX1000-5-A
Oct 29, 2015
· Device
Terminated
NxStage Dialysate Sack (SAK) with Concentrate
for Use with PureFlow SL
REF: SAK-407
Lactate 40, Potassium 1, S...
Jun 24, 2014
· Device
Terminated
NxStage Dialysate Sack (SAK) with Concentrate
for Use with PureFlow SL
REF: SAK-307
Lactate 40, Potassium 1, S...
Jun 24, 2014
· Device
Terminated
NxStage Dialysate Sack (SAK) with Concentrate
for Use with PureFlow SL
REF: SAK-305
Lactate 45, Potassium 1, S...
Jun 24, 2014
· Device
Terminated
NxStage Dialysate Sack (SAK) with Concentrate
for Use with PureFlow SL
REF: SAK-303
Lactate 45, Potassium 1, S...
Jun 24, 2014
· Device
Terminated
NxStage Dialysate Sack (SAK) with Concentrate
for Use with PureFlow SL
REF: SAK-301
Lactate 45, Potassium 1,...
Jun 24, 2014
· Device
Terminated
NxStage Dialysate Sack (SAK) with Concentrate
for Use with PureFlow SL
REF: SAK-306
Lactate 45, Potassium 2, S...
Jun 24, 2014
· Device
Terminated
NxStage Dialysate Sack (SAK) with Concentrate
for Use with PureFlow SL
REF: SAK-304
Lactate 45, Potassium 2, S...
Jun 24, 2014
· Device
Terminated
NxStage Dialysate Sack (SAK) with Concentrate
for Use with PureFlow SL
REF: SAK-302
Lactate , 40, Potassium 1,...
Jun 24, 2014
· Device
Terminated
NxStage PureFlow-B Solution; Model/Catalog Number: RFP-401. Product is packaged in a case containing two indi...
Feb 24, 2014
· Device
Terminated
NxStage PureFlow-B Solution, Model/Catalog Number: RFP-401, packaged in a case
The NxStage PureFLow-B Soluti...
May 2, 2013
· Device
Terminated
NXStage PureFlow SL SAK-303 - 2 dialysate sacks (SAK) with concentrate for use with PureFlow SL, Rx
The NxSta...
Jan 20, 2012
· Device
Terminated
NxStage Cartridge Express, CAR-170, for hemodialysis.
Sep 20, 2007
· Device
Terminated
NxStage Cartridge Express. A disposable extracorporeal blood and fluid pathway and a hemo filter. Model # CAR-...
Jul 20, 2004
· Device
Terminated
NxStage Cartridge Express. A disposable extracorporeal blood and fluid pathway and a hemo filter. Model #CAR-1...
Jul 20, 2004
· Device
Terminated
NxStage Cartridge Express. A disposable extracorporeal blood and fluid pathway and a hemo filter. Model #CAR-1...
Jul 20, 2004
· Device
Terminated