The Recall Desk

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.

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21701–21725 of 40299

  • ModerateFDA (Devices)·Z-0554-2019·2018-12-12

    Pfizer Recalls Thermacare HeatWraps Due to Leaking Granular Material

    Pfizer is recalling Thermacare Muscle Pain Therapy HeatWraps because the wraps may come apart and leak granular material.

    Product
    Thermacare Muscle Pain Therapy HeatWraps: a) UPC 0573301314 b) UPC 0573301303 Product Usage: Provides heat therapy for temporary relief of minor muscular and joint aches and pains associated with overexertion, sprains, and arthritis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0529-2019·2018-12-12

    Helena Laboratories Recalls Gel Alkaline Phosphatase Isoenzyme Control Kits

    Helena Laboratories is recalling 43 Gel Alkaline Phosphatase Isoenzyme Control Kits due to customer complaints of lower enzyme activity.

    Product
    Gel Alkaline Phosphatase Isoenzyme Control Kit: Gel Alkaline Phosphatase Isoenzyme Control Cat. No. 5104 1 x 2.0 mL FOR IN-VITRO DIAGNOSTIC USE Gel Alkaline Phosphatase Isoenzyme Control 20mL 001831 Alkaline Phosphatase Isoenzyme Control is to be used as a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0526-2019·2018-12-12

    Neomed NeoConnect Enteral Extension Sets Recalled for Incorrect Expiration Date

    Neomed Inc is recalling NeoConnect Enteral Extension Sets because the sterile pouch labels display an incorrect expiration date of 2016-11-19 instead of 2019-11-09.

    Product
    NEOCONNECT, Enteral Extension with ENFit connector, REF EXT-60NC The NeoMed NeoConnect Enteral Only Extension Set is intended for use as an extension set for nasogastric/oralgastric or gastric tube enteral feeding tubes, incorporating safety connectors which help mitigate…
    Category
    Medical Device
    Distribution
    8 states
  • SevereFDA (Devices)·Z-0507-2019·2018-12-05

    NxStage PureFlow B Solution Recalled for Potential Bag Bursting Hazard

    NxStage Medical is recalling PureFlow B Solution because the smaller chamber of the bag can burst, releasing electrolyte fluid that may cause injury if it contacts eyes or skin.

    Product
    NxStage PureFlow B Solution-RFP-RFP-456, 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-0514-2019·2018-12-05

    Eurotrol HemoTrol Level 2 Recalled Due to Microbial Contamination

    Eurotrol Inc. is recalling HemoTrol Level 2 hematology quality control mixtures because microbial contamination causes incorrect measurement results.

    Product
    HemoTrol Level 2- In Vitro Diagnostic Hematology quality control mixture Catalogue number: 171.002.002 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
  • 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
  • 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