Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

NxStage System One S Cycler (High Permeability Hemodialysis System) Model Recalled by NxStage Medical, Inc. Due to Ultrafiltration (UF) Volume software error inaccurate fluid removal

Date: October 29, 2015
Company: NxStage Medical, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact NxStage Medical, Inc. directly.

Affected Products

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

Quantity: 16 units

Why Was This Recalled?

Ultrafiltration (UF) Volume software error inaccurate fluid removal

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About NxStage Medical, Inc.

NxStage Medical, Inc. has 29 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report