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

21626–21650 of 40175

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
SevereFDA (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-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-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
ModerateFDA (Devices)·Z-0510-2019·2018-12-05
Numed Multi-Track Angiographic Catheter Recall for Missing Instructions
Numed Inc is recalling 100 units of Multi-Track Angiographic Catheters because the Instructions for Use booklets were not included on the outer pouch.
Product
Multi-Track Angiographic Catheter (MMTA) Product Code: MMTA05100 Product Usage: Recommended for use in catheterization for angiography of cardiovascular vessels and I or chambers. It can be used for injection of contrast medium and pressure measurement in any chamber or…
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0517-2019·2018-12-05
Fresenius Granuflo Dry Acid Concentrate Recalled for Foreign Substance
Fresenius Medical Care is recalling specific lots of Granuflo Dry Acid Concentrate for hemodialysis due to the presence of a foreign substance.
Product
Fresenius Granuflo Dry Acid Concentrate- 2K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD2251-3B for hemodialysis
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0519-2019·2018-12-05
GE Healthcare Recalls Dash 3000 Patient Monitoring Systems
GE Healthcare is recalling Dash 3000 patient monitors because they may restart simultaneously during prolonged network overloads.
Product
Dash 3000 Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0498-2019·2018-12-05
Stryker Recalls Reprocessed Xcel Bladeless Trocars Due to Distribution Error
Stryker Sustainability Solutions is recalling 4,848 reprocessed Xcel Bladeless Trocars (H12LP) because they were distributed to facilities after a previous recall was executed.
Product
Reprocessed Xcel Bladeless Trocar (H12LP) Model # H12LP Reprocessed Endoscopic Trocars12x100mm - Product Usage: Physical Product Description: The Reprocessed Blunt Tip Trocar consists of a radiolucent cannula and obturator sized 12mm in diameter (refer to Figure 1). The…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0513-2019·2018-12-05
PerkinElmer QSight 210 MD Mass Spectrometer Software Data Overwrite Recall
PerkinElmer is recalling 18 QSight 210 MD mass spectrometers because a software defect may overwrite original data from the last acquired sample when automatic flush is enabled.
Product
PerkinElmer QSight 210 MD Mass Spectrometer Simplicity 3Q MD v1.0 with Hot Fix 2 Software intended to identify compounds in human samples by ionizing the compound and separating the resulting ions. Part Number: BC004872
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-0509-2019·2018-12-05
Tosoh AIA-900 Analyzer Recalled for Potential Drive Motor Failure
Tosoh Bioscience is recalling 247 AIA-900 Automated Immunoassay Analyzers due to a potential drive motor defect that may cause the device to stop functioning and delay patient test results.
Product
AIA-900 Automated Immunoassay Analyzer, product code 022930 /022930R Product Usage: The AIA-900 is capable of performing three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymetric…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0499-2019·2018-12-05
Siemens Dimension Vista Lactate Dehydrogenase Reagent Cartridge Recall
Siemens is recalling Dimension Vista Lactate Dehydrogenase reagent cartridges because they may produce falsely elevated results if used after Lactic Acid assays.
Product
Dimension Vista Lactate Dehydrogenase (LDI) Flex reagent cartridge, an in vitro diagnostic test for the quantitative measurement of lactate dehydrogenase in human serum and plasma on the Dimension Vista¿ System.Cat. No. K2054, Mat. No. 10464323
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0516-2019·2018-12-05
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- 2K 2.0 Ca 1 Mg 16.5 GAL Catalog Number: OFD2201-3B for hemodialysis
Category
Medical Device
Distribution
Distributed nationwide

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21626–21650 of 40175