NxStage Express Fluid Warmer — Class II medical device recall Z-2793-2018
Terminated recall by NxStage Medical, Inc., reported 2018-08-22, distributed nationwide. There is a potential risk of electrical fire when fluid leaks into the power receptacle on the back of the war
| Recall number | Z-2793-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | NxStage Medical, Inc., Lawrence, MA, United States |
| Recall initiated | 2018-06-11 |
| Classified | 2018-08-13 |
| Reported by FDA | 2018-08-22 |
| Terminated | 2020-04-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, DE, ES, FR, GB, IT, KW, NL, SA, SE |
| Quantity | 14,975 |
| Reason classes | packaging |
Product
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 the NxStage System One used to warm therapy fluids prior to administration.
Reason for recall
There is a potential risk of electrical fire when fluid leaks into the power receptacle on the back of the warmer. The risk exists any time the warmer is plugged in. The firm has received 7 reports of smoke, sparks, or flames coming from the Express Fluid Warmer since 2016. No adverse events have been reported.
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-2793-2018. 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.