Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means the agency’s own highest classification or reported deaths or serious injuries, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

16501–16525 of 27500

SevereFDA (Devices)·Z-0506-2019·2018-12-05
NxStage PureFlow B Solution Recalled Due to Bag Bursting Risk
NxStage Medical is recalling 7,275 units of PureFlow B Solution because the bag's smaller chamber may burst, releasing electrolyte fluid that can injure eyes or skin.
Product
NxStage PureFlow B Solution-RFP-RFP-454, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0470-2019·2018-12-05
Synaptive Medical Recalls BrightMatter Guide Software Due to Defect
Synaptive Medical Inc is recalling 37 units of BrightMatter Guide software due to a defect that occurs when switching between specific port trajectories during surgery.
Product
BrightMatter Guide, Product Number SYN-0026, Versions: 1.5.0, 1.5.1 and 1.5.2 Product Usage: BrightMatter Guide can navigate a third-party port (NICO BrainPath device) by attaching Synaptive s custom Tracking Array to the port directly. As the BrainPath is navigable in two…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0437-2019·2018-12-05
Maquet Cardiovascular Recalls QUADROX-i Neonatal Membrane Oxygenators
Maquet Cardiovascular is recalling QUADROX-i Neonatal membrane oxygenators due to a potential for blood leakage at the blood inlet connector when using a specific reducing screw adapter.
Product
QUADROX-i Neonatal with integrated arterial filter and VHK 11000 (VKMO 11000-USA#QUADROX-i Neo.+Reservoir), Part Number 701055207 The membrane oxygenator QUADROXi Neonatal is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0502-2019·2018-12-05
NxStage PureFlow B Solution Recalled for Potential Bag Bursting and Injury
NxStage Medical is recalling specific lots of PureFlow B Solution because the smaller chamber of the two-chamber bag can burst, releasing electrolyte fluid that may cause injury if it contacts eyes or skin.
Product
NxStage PureFlow B Solution-RFP-402, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0505-2019·2018-12-05
NxStage PureFlow B Solution Recalled for Potential Bag Bursting
NxStage Medical is recalling PureFlow B Solution because the bag's smaller chamber may burst, releasing electrolyte fluid that can injure eyes or skin.
Product
NxStage PureFlow B Solution-RFP-406, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0521-2019·2018-12-05
GE Healthcare Recalls Dash 5000 Patient Monitoring Systems
GE Healthcare is recalling approximately 182,640 Dash 5000 Patient Monitoring Systems because they may simultaneously restart during prolonged network overloads.
Product
Dash 5000 Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0524-2019·2018-12-05
GE Healthcare Recalls Solar 9500 Patient Monitors Due to Network Overload Risk
GE Healthcare is recalling approximately 3,864 Solar 9500 Information Monitoring Systems because they may simultaneously restart if connected to the same network during a prolonged network overload.
Product
Solar 9500 Information Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0523-2019·2018-12-05
GE Healthcare Recalls Solar 8000M Patient Monitoring Systems
GE Healthcare is recalling Solar 8000M patient monitors because they may restart simultaneously during network overload, potentially disrupting patient monitoring.
Product
Solar 8000M Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0522-2019·2018-12-05
GE Healthcare Recalls Solar 8000i Patient Monitoring Systems
GE Healthcare is recalling approximately 73,673 Solar 8000i and 8000M patient monitoring systems because they may simultaneously restart during prolonged network overloads.
Product
Solar 8000i Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0518-2019·2018-12-05
Fresenius Granuflo Dry Acid Concentrate Recalled for Foreign Substance
Fresenius Medical Care is recalling Granuflo Dry Acid Concentrate for hemodialysis due to confirmed foreign substance contamination.
Product
Fresenius Granuflo Dry Acid Concentrate- 3K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD3251-3B for hemodialysis
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0501-2019·2018-12-05
NxStage PureFlow B Solution Recalled Due to Bag Burst Risk
NxStage Medical is recalling PureFlow B Solution because the smaller chamber of the two-chamber bag can burst, releasing electrolyte fluid that may injure eyes or skin.
Product
NxStage PureFlow B Solution-RFP-401, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0436-2019·2018-12-05
Maquet QUADROX-i Neonatal Membrane Oxygenator Recalled for Blood Leakage Risk
Maquet is recalling QUADROX-i Neonatal membrane oxygenators because a specific reducing screw adapter may cause blood leakage at the inlet connector.
Product
QUADROX-i Neonatal without integrated arterial filter and VHK 11000 (VKMO 10000-USA#QUADROX-i Neo.+Reservoir), Part Number 701055120 The membrane oxygenator QUADROXi Neonatal is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0515-2019·2018-12-05
Eurotrol HemoTrol Level 3 Recalled Due to Microbial Contamination
Eurotrol Inc. is recalling HemoTrol Level 3 hematology quality control mixtures because microbial contamination causes incorrect, lower-than-assigned measurement results.
Product
HemoTrol Level 3- In Vitro Diagnostic Hematology quality control mixture. Catalogue number: 171.003.002 Eurotrol HemoLin is an assayed hemoglobin control intended for professional use in the verification of the linearity of the HemoCue¿ Hb 201 systems.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0520-2019·2018-12-05
GE Healthcare Recalls Dash 4000 Patient Monitoring Systems
GE Healthcare is recalling Dash 4000 Patient Monitoring Systems because they may simultaneously restart if connected to the same network during a prolonged network overload.
Product
Dash 4000 Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0504-2019·2018-12-05
NxStage PureFlow B Solution Recalled for Potential Bag Burst Injury Risk
NxStage Medical is recalling PureFlow B Solution because the smaller chamber of the two-chamber bag can burst, releasing electrolyte fluid that may cause injury if it contacts eyes or skin.
Product
NxStage PureFlow B Solution-RFP-404, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0500-2019·2018-12-05
NxStage PureFlow B Solution Recalled for Potential Bag Bursting
NxStage Medical is recalling 59,100 units of PureFlow B Solution because the smaller chamber may burst, releasing electrolyte fluid that can injure eyes or skin.
Product
NxStage PureFlow B Solution-RFP-400, Premixed Dialysate for Hemodialysis. NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0503-2019·2018-12-05
NxStage PureFlow B Solution Recalled Due to Bag Burst Risk
NxStage Medical is recalling 2,189 units of PureFlow B Solution because the bag's smaller chamber can burst, releasing electrolyte fluid that may injure eyes or skin.
Product
NxStage PureFlow B Solution-RFP-403, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0512-2019·2018-12-05
Smiths Medical Recalls Medex High Pressure Stopcocks Due to Leak Risk
Smiths Medical ASD Inc. is recalling specific lots of Medex High Pressure Stopcocks because an inner body defect may cause the device to leak.
Product
Medex High Pressure Stopcock used to control the direction of IV fluid flow. This device is intended for single use only and is provided sterile and fluid path non-pyrogenic unless package is damaged or opened.
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0490-2019·2018-11-28
Smiths Medical Recalls Irrisept OR Bottle Assemblies Due to Sterility Risk
Smiths Medical is recalling 10,440 Irrisept OR bottle assemblies because leaking containers may compromise sterility, posing an infection risk.
Product
Irrisept OR, Finished Bottle Assembly 450 ml STEP 1
Category
Medical Device
Distribution
37 states
SevereFDA (Devices)·Z-0488-2019·2018-11-28
Sedecal NOVA FA DR System Recalled for Potential Cable Failure
Sedecal S.A. is recalling 145 NOVA FA DR diagnostic radiography systems because installation or maintenance issues could cause support cables to break, leading to equipment falling.
Product
Sedecal NOVA FA DR System. for diagnostic radiography.
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0478-2019·2018-11-28
Voluntis Recalls Insulia Diabetes Management Companion Due to Calculator Bug
Voluntis is recalling the Insulia Diabetes Management Companion because a bug in the Android basal calculator could cause hypoglycemia. An update is available to resolve the issue.
Product
Insulia Diabetes Management Companion
Category
Medical Device
Distribution
5 states
SevereFDA (Devices)·Z-0474-2019·2018-11-28
Boston Scientific Recalls SQ-RX Pulse Generators for Battery Malfunctions
Boston Scientific is recalling 12,900 SQ-RX Pulse Generators used in S-ICD systems due to latent internal battery malfunctions that cause accelerated depletion.
Product
The SQ-RX Pulse Generator a component of the Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System The S-ICD System is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0475-2019·2018-11-28
Tosoh AIA-2000 Analyzer Recall Due to Potential Wash Solution Defect
Tosoh Bioscience is recalling seven AIA-2000 analyzers because a liquid suction pump defect may cause incomplete washing, leading to inaccurate test results.
Product
AIA-2000 Analyzer, Model Nos. AIA-2000LA, AIA-2000ST - Product Usage: The AIA-2000 is capable of performing three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymetric immunoassay. An…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0471-2019·2018-11-28
Beckman Coulter Flow Cytometers Recalled for Amplifier Board Defect
Beckman Coulter is recalling Cytomics FC 500 and EPICS XL flow cytometers due to a manufacturing defect on the amplifier board that may cause signal loss or drifting.
Product
1) Cytomics FC 500 With CXP Software BECKMAN COULTER 2) Cytomics FC 500 MPL With MXP Software BECKMAN COULTER flow cytometer for in vitro diagnostics
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0482-2019·2018-11-28
GE Healthcare Recalls Panda iRes Infant Radiant Warmers Due to Electric Leakage
GE Healthcare is recalling 1,724 Panda iRes Infant Radiant Warmers worldwide due to a potential electric leakage hazard that could affect users.
Product
Panda iRes Infant Radiant Warmer. Device sold under the following product names: Panda iRes Warmer and Panda iRes Bedded Warmer.
Category
Medical Device
Distribution
Distributed nationwide

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16501–16525 of 27500