NxStage System One S Cycler — Class II medical device recall Z-0335-2016
Terminated recall by NxStage Medical, Inc., reported 2015-12-02. Ultrafiltration Volume (UFV) may not decrease during treatment-software error. The UF pump may continue to run
| Recall number | Z-0335-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | NxStage Medical, Inc., Lawrence, MA, United States |
| Recall initiated | 2015-10-29 |
| Classified | 2015-11-25 |
| Reported by FDA | 2015-12-02 |
| Terminated | 2019-11-19 |
| Quantity | 2,134 units |
| Reason classes | software |
| Model numbers | NX1000-3 |
Product
NxStage System One S Cycler - Model no. NX1000-3. For home hemodialysis.
Reason for recall
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0335-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.