PlainRecalls

NxStage Medical, Inc.

Compiled from official public sources by the editorial team.

31 recalls on record · Latest: Jun 4, 2025

NxStage Medical, Inc. Recall Insight

NxStage Medical, Inc. appears on 31 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.030% of the federal archive, a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Jun 4, 2025, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 31 entries, severity tagging shows 0 critical, 31 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 31 of 31 entries, unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (31). The date window on this page runs from May 8, 2013 to Jun 4, 2025.

Manufacturer-level browsing is useful when monitoring a single firm for patterns, whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current, deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement, always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Moderate Jun 4, 2025

NxStage PureFlow-B Solution. Catalog numbers: RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-406, RFP-453, RFP-454, RFP-456.

FDA Devices Moderate Jun 26, 2024

NxStage PureFlow-B Solution, Premixed Dialysate for Hemodialysis, Device Catalog Numbers RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-405, RFP-40…

FDA Devices Moderate Dec 25, 2019

Low Volume Cartridge IFU (SKU CAR-125-B) used with the following devices: 1) NxStage One, Model NX1000-1; 2) NxStage VersiHD Cycler, Model Number…

FDA Devices Moderate Jun 12, 2019

NxStage PureFlow B Solution, REF RFP-401, M535RPF4010 NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that…

FDA Devices Moderate Jun 12, 2019

NxStage PureFlow B Solution, REF RFP-400, M535RFP4000 Product NxStage PureFlow B Solution is indicated for use with renal replacement therapy sys…

FDA Devices Moderate Dec 5, 2018

NxStage PureFlow B Solution-RFP-402, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement …

FDA Devices Moderate Dec 5, 2018

NxStage PureFlow B Solution-RFP-400, Premixed Dialysate for Hemodialysis. NxStage PureFlow B Solution is indicated for use with renal replaceme…

FDA Devices Moderate Dec 5, 2018

NxStage PureFlow B Solution-RFP-RFP-456, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacem…

FDA Devices Moderate Dec 5, 2018

NxStage PureFlow B Solution-RFP-401, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement …

FDA Devices Moderate Dec 5, 2018

NxStage PureFlow B Solution-RFP-RFP-454, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacem…

FDA Devices Moderate Dec 5, 2018

NxStage PureFlow B Solution-RFP-404, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement …

FDA Devices Moderate Dec 5, 2018

NxStage PureFlow B Solution-RFP-406, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement …

FDA Devices Moderate Dec 5, 2018

NxStage PureFlow B Solution-RFP-403, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacemen…

FDA Devices Moderate Aug 22, 2018

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 t…

FDA Devices Moderate Mar 28, 2018

NxStage PureFlow B Solution - Premixed Dialysate for Hemodialysis with NxStage System One

FDA Devices Moderate Mar 7, 2018

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-M535SAK304…

FDA Devices Moderate Dec 2, 2015

NxStage System One S Cycler (High Permeability Hemodialysis System) Model no. NX1000-5

FDA Devices Moderate Dec 2, 2015

NxStage System One S Cycler -High Permeability Hemodialysis System Model no. NX1000-4

FDA Devices Moderate Dec 2, 2015

NxStage System One S Cycler - Model no. NX1000-3-A (OUS). For home hemodialysis.

FDA Devices Moderate Dec 2, 2015

NxStage System One S Cycler - Model no. NX1000-3. For home hemodialysis.

FDA Devices Moderate Dec 2, 2015

NxStage System One S Cycler (High Permeability Hemodialysis System) Model no. NX1000-5-A

FDA Devices Moderate Jul 2, 2014

NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-302 Lactate , 40, Potassium 1, Sodium 140, Calcium 3, Magnesium 1…

FDA Devices Moderate Jul 2, 2014

NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-305 Lactate 45, Potassium 1, Sodium 140, Calcium 3, Magnesium 1 C…

FDA Devices Moderate Jul 2, 2014

NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-304 Lactate 45, Potassium 2, Sodium 140, Calcium 3,Magnesium 1, …

FDA Devices Moderate Jul 2, 2014

NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-306 Lactate 45, Potassium 2, Sodium 140, Calcium 3, Magnesium 1, …

FDA Devices Moderate Jul 2, 2014

NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-307 Lactate 40, Potassium 1, Sodium 140, Calcium 3, Magnesium 1, …

FDA Devices Moderate Jul 2, 2014

NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-303 Lactate 45, Potassium 1, Sodium 140, Calcium 3, Magnesium 100m…

FDA Devices Moderate Jul 2, 2014

NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-407 Lactate 40, Potassium 1, Sodium 140, Calcium 3, Magnesium 1, …

FDA Devices Moderate Jul 2, 2014

NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-301 Lactate 45, Potassium 1, Sodium 140, Calcium 3, Magnesium 1, …

FDA Devices Moderate Mar 5, 2014

NxStage PureFlow-B Solution; Model/Catalog Number: RFP-401. Product is packaged in a case containing two individual 5L bags. The NxStage PureFl…

FDA Devices Moderate May 8, 2013

NxStage PureFlow-B Solution, Model/Catalog Number: RFP-401, packaged in a case The NxStage PureFLow-B Solution is indicated for use with renal re…

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

Compare NxStage Medical, Inc. with Zimmer Biomet, Inc. →

Data Sources

  • Source: FDA + CPSC + NHTSA - federal recall filings naming this firm. Verify with FDA, CPSC, or NHTSA directly.
  • Source: PlainRecalls Manufacturer Index - firm-level aggregation across all three federal recall feeds

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.