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Browse Device Recalls

29 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 29 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 29 FDA device recalls.

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DateProductReasonClassFirm
Aug 27, 2019 Low Volume Cartridge IFU (SKU CAR-125-B) used with the following devices: ... There is a potential patient health risk while performing chronic hemodialysis treatments in the ... Class II NxStage Medical, Inc.
Apr 11, 2019 NxStage PureFlow B Solution, REF RFP-400, M535RFP4000 Product NxStage Pure... Certain lots were mislabeled with incorrect product number. Class II NxStage Medical, Inc.
Apr 11, 2019 NxStage PureFlow B Solution, REF RFP-401, M535RPF4010 NxStage PureFlow B S... Certain lots were mislabeled with incorrect product number. Class II NxStage Medical, Inc.
Oct 17, 2018 NxStage PureFlow B Solution-RFP-403, Premixed Dialysate for Hemodialysis ... PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause... Class II NxStage Medical, Inc.
Oct 17, 2018 NxStage PureFlow B Solution-RFP-406, Premixed Dialysate for Hemodialysis ... PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause... Class II NxStage Medical, Inc.
Oct 17, 2018 NxStage PureFlow B Solution-RFP-404, Premixed Dialysate for Hemodialysis ... PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause... Class II NxStage Medical, Inc.
Oct 17, 2018 NxStage PureFlow B Solution-RFP-RFP-454, Premixed Dialysate for Hemodialysis ... PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause... Class II NxStage Medical, Inc.
Oct 17, 2018 NxStage PureFlow B Solution-RFP-401, Premixed Dialysate for Hemodialysis ... PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause... Class II NxStage Medical, Inc.
Oct 17, 2018 NxStage PureFlow B Solution-RFP-RFP-456, Premixed Dialysate for Hemodialysis ... PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause... Class II NxStage Medical, Inc.
Oct 17, 2018 NxStage PureFlow B Solution-RFP-400, Premixed Dialysate for Hemodialysis. ... PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause... Class II NxStage Medical, Inc.
Oct 17, 2018 NxStage PureFlow B Solution-RFP-402, Premixed Dialysate for Hemodialysis ... PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause... Class II NxStage Medical, Inc.
Jun 11, 2018 NxStage Express Fluid Warmer (FW-300, FW-300-A, FW-300-WW, FW-301, FW-301-A) ... There is a potential risk of electrical fire when fluid leaks into the power receptacle on the ba... Class II NxStage Medical, Inc.
Jan 29, 2018 NxStage Dialysate Sack: 1) REF SAK-301 UDI-M535SAK3010, 2) REF SAK-302 UDI-M5... May contain endotoxin levels which have been confirmed to exceed the ANSI/AAMI quality standard d... Class II NxStage Medical, Inc.
Nov 10, 2017 NxStage PureFlow B Solution - Premixed Dialysate for Hemodialysis with NxStag... Using different fluid formulations of NxStage PureFlow B Solution at the same time during treatme... Class II NxStage Medical, Inc.
Oct 29, 2015 NxStage System One S Cycler (High Permeability Hemodialysis System) Model no... Ultrafiltration (UF) Volume software error inaccurate fluid removal Class II NxStage Medical, Inc.
Oct 29, 2015 NxStage System One S Cycler - Model no. NX1000-3. For home hemodialysis. Ultrafiltration Volume (UFV) may not decrease during treatment-software error. The UF pump may c... Class II NxStage Medical, Inc.
Oct 29, 2015 NxStage System One S Cycler - Model no. NX1000-3-A (OUS). For home hemodia... Ultrafiltration Volume (UFV) may not decrease during treatment-software error. The UF pump may c... Class II NxStage Medical, Inc.
Oct 29, 2015 NxStage System One S Cycler -High Permeability Hemodialysis System Model no... Ultrafiltration Volume (UFV) may not decrease during treatment-software error. The UF pump may co... Class II NxStage Medical, Inc.
Oct 29, 2015 NxStage System One S Cycler (High Permeability Hemodialysis System) Model no... Ultrafiltration (UF) Volume software error inaccurate fluid removal Class II NxStage Medical, Inc.
May 14, 2014 NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF:... SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification Class II NxStage Medical, Inc.
May 14, 2014 NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF:... SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification Class II NxStage Medical, Inc.
May 14, 2014 NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF:... SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification Class II NxStage Medical, Inc.
May 14, 2014 NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF:... SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification Class II NxStage Medical, Inc.
May 14, 2014 NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF:... SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification Class II NxStage Medical, Inc.
May 14, 2014 NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF:... SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification Class II NxStage Medical, Inc.
May 14, 2014 NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF:... SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification Class II NxStage Medical, Inc.
May 14, 2014 NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF:... SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification Class II NxStage Medical, Inc.
Jan 24, 2014 NxStage PureFlow-B Solution; Model/Catalog Number: RFP-401. Product is packa... Mislabeled product. Class II NxStage Medical, Inc.
Mar 18, 2013 NxStage PureFlow-B Solution, Model/Catalog Number: RFP-401, packaged in a cas... Product may be mislabeled. Class II NxStage Medical, Inc.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.