NxStage Medical recalls

NxStage Medical has 31 recalls on record with the FDA and USDA, the earliest in 2013 and the latest reported on 4 Jun 2025. 2 are still ongoing. The most frequent reason is packaging defects.

Total recalls31since 2013

Last 12 months0reported

Class I00% of total

Ongoing2latest 4 Jun 2025

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 1 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 31 100%Class III 0 0%

Why nxstage medical is recalled

Product types

Other Medical Devices2374%
Insulin Pumps & Glucose Monitors826%

By year

202513%
202413%
2019310%
20181135%
2015516%
2014929%
201313%

Ongoing nxstage medical recalls

2 active

Reported	Class	Recall	Company	Reason	Where
4 Jun 2025Device	CLASS II	NxStage PureFlow-B Solution recalled by NxStage Medical	NxStage Medical	Packaging Defects	Nationwide
26 Jun 2024Device	CLASS II	NxStage PureFlow-B Solution, Premixed Dialysate recalled	NxStage Medical	Other	Nationwide

All nxstage medical recalls, newest first

31 total

Reported	Class	Recall	Company	Reason	Where
4 Jun 2025Device	CLASS II	NxStage PureFlow-B Solution recalled by NxStage Medical	NxStage Medical	Packaging Defects	Nationwide
26 Jun 2024Device	CLASS II	NxStage PureFlow-B Solution, Premixed Dialysate recalled	NxStage Medical	Other	Nationwide
25 Dec 2019Device	CLASS II	Low Volume Cartridge IFU recalled by NxStage Medical	NxStage Medical	Other	5 states
12 Jun 2019Device	CLASS II	NxStage PureFlow B Solution recalled by NxStage Medical	NxStage Medical	Labeling Errors	Nationwide
12 Jun 2019Device	CLASS II	NxStage PureFlow B Solution recalled by NxStage Medical	NxStage Medical	Labeling Errors	Nationwide
5 Dec 2018Device	CLASS II	NxStage PureFlow B Solution-RFP-403, Premixed Dialysate recalled	NxStage Medical	Sterility	Nationwide
5 Dec 2018Device	CLASS II	NxStage PureFlow B Solution-RFP-406, Premixed Dialysate recalled	NxStage Medical	Sterility	Nationwide
5 Dec 2018Device	CLASS II	NxStage PureFlow B Solution-RFP-404, Premixed Dialysate recalled	NxStage Medical	Sterility	Nationwide
5 Dec 2018Device	CLASS II	NxStage PureFlow B Solution-Rfp-rfp recalled by NxStage Medical	NxStage Medical	Sterility	Nationwide
5 Dec 2018Device	CLASS II	NxStage PureFlow B Solution-RFP-401, Premixed Dialysate recalled	NxStage Medical	Sterility	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.