--- title: "NxStage Medical Inc Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search NxStage Medical Inc recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/nxstage-medical-inc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # NxStage Medical Inc recall records **2** reported ongoing 2 records in this archive. Latest source date Apr 28, 2025. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Apr 28, 2025 FDA device enforcement ### [NxStage PureFlow-B Solution. Catalog numbers: RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-406, RFP-453, RFP-454, RFP-456.](https://isitonrecall.com/recall/fda-device-z-1864-2025-nxstage-pureflow-b-solution-catalog-numbers-rfp-400-rfp-401-rfp-402-rfp-403-rfp-404-rfp-406-rfp-453/) Potential for the perimeter seal on the small chamber of the two-chamber bag to fail causing the electrolyte fluid to splash into the face of the user when attempting to open the peel seam to mix the two chambers prior to treatment. Class II Reported ongoing Distribution: US Nationwide distribution. [Official source for NxStage PureFlow-B Solution. Catalog numbers: RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-40...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1864-2025%22) May 14, 2024 FDA device enforcement ### [NxStage PureFlow-B Solution, Premixed Dialysate for Hemodialysis, Device Catalog Numbers RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-405, RFP-406, RFP-453, RFP-454, RFP-456](https://isitonrecall.com/recall/fda-device-z-2160-2024-nxstage-pureflow-b-solution-premixed-dialysate-for-hemodialysis-device-catalog-numbers-rfp-400-rfp-4/) The smaller chamber of the two chamber bag is bursting when nurses are attempting to mix the two chambers prior to use. The electrolyte fluid in the small chamber of the NxStage PureFlow B Solution has a pH of less than 2.0. The solution can be harmful if i... Class II Reported ongoing Distribution: US Nationwide distribution. [Official source for NxStage PureFlow-B Solution, Premixed Dialysate for Hemodialysis, Device Catalog Numbers RFP-400,...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2160-2024%22) ## Reasons in these listed records - Potential for the perimeter seal on the small chamber of the two-chamber bag to fail causing the electrolyte fluid to splash into the face of the user when attempting to open the peel seam to mix the two chambers prior to treatment. - The smaller chamber of the two chamber bag is bursting when nurses are attempting to mix the two chambers prior to use. The electrolyte fluid in the small chamber of the NxStage PureFlow B Solution has a pH of less than 2.0. The solution can be harmful if it comes in contact w... These examples come from this result page and are not a ranking of every recall reason. ## Checking NxStage Medical Inc ### Is there a recall on nxstage medical inc right now? This archive contains 2 records, including 2 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search NxStage Medical Inc](https://isitonrecall.com/check/?q=NxStage%20Medical%20Inc) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)