Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
NxStage System One S Cycler - Model no. NX1000-3. For home hemodialysis. Recalled by NxStage Medical, Inc. Due to Ultrafiltration Volume (UFV) may not decrease during treatment-software...
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 - Model no. NX1000-3. For home hemodialysis.
Quantity: 2,134 units
Why Was This Recalled?
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
Where Was This Sold?
Worldwide Distribution.
About NxStage Medical, Inc.
NxStage Medical, Inc. has 29 total recalls tracked by RecallDetector.
Related Recalls
EndoVive Safety PEG Kit Recalled by Boston Scientific Corporation Due to Recall of kits which utilized ChloraPrep Triple Swabsticks...
Boston Scientific Corporation · February 10, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Artelon FlexBand Dynamic Matrix Ref: 31057 Recalled by International Life Sciences Due to Augmentation devices failed bacterial endotoxin testing.
International Life Sciences · February 6, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Data sourced from the FDA (Device). Last updated March 26, 2026. View original report