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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13976–14000 of 27500

  • HighFDA (Devices)·Z-1562-2020·2020-04-01

    Dexcom G6 Continuous Glucose Monitoring System Recalled for Hydroxyurea Interference

    Dexcom Inc is recalling G6 Continuous Glucose Monitoring Systems because the anti-neoplastic drug hydroxyurea may cause falsely elevated glucose readings.

    Product
    Dexcom G6 Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monitoring device indicated for detecting trends and tracking patterns in persons (age 18 and older) with diabetes.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1592-2020·2020-04-01

    Medtronic MiniMed Paradigm Insulin Pump Recalled for Cybersecurity Vulnerability

    Medtronic MiniMed is recalling 27 Paradigm insulin pumps due to a cybersecurity vulnerability that could allow unauthorized wireless control of insulin delivery.

    Product
    Medtronic MiniMed Paradigm Insulin pump, model number MMT-523K
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1556-2020·2020-04-01

    Abbott Precision Xtra Blood Glucose Meters Recalled for Uncleared Disinfection Instructions

    Abbott is recalling Precision Xtra Blood Glucose & Ketone Monitoring Systems because instructions for disinfecting the devices were not cleared by the FDA and could lead to infection.

    Product
    Precision Xtra Blood Glucose & Ketone Monitoring System, UDI: 00093815715023, 00093815988144
    Category
    Medical Device
    Distribution
    32 states
  • HighFDA (Devices)·Z-1561-2020·2020-04-01

    Dexcom G5 and G4 PLATINUM Systems Recalled for Hydroxyurea Interference

    Dexcom Inc is recalling G5 and G4 PLATINUM Continuous Glucose Monitoring Systems because hydroxyurea use may cause falsely elevated glucose readings.

    Product
    Dexcom G5 Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monitoring device indicated for detecting trends and tracking patterns in persons (age 18 and older) with diabetes.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1528-2020·2020-04-01

    Ev3 Pipeline Flex Embolization Device Recalled for Delivery System Fracture Risk

    Micro Therapeutics is recalling 762 Ev3 Pipeline Flex Embolization Devices because the delivery system may fracture during implantation, potentially leaving parts in the patient.

    Product
    ev3 Pipeline Flex Embolization Device with Shield Technology. Sold OUS. For neurological endovascular use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1593-2020·2020-04-01

    Medtronic MiniMed Paradigm Insulin Pump Recalled for Cybersecurity Vulnerabilities

    Medtronic MiniMed is recalling 10 Paradigm insulin pumps due to cybersecurity vulnerabilities that could allow unauthorized wireless control of insulin delivery.

    Product
    Medtronic MiniMed Paradigm Insulin pump, model number MMT-723K
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1532-2020·2020-04-01

    Karl Storz Fiberscope Recall Due to Incorrect Sterilization Instructions

    Karl Storz is recalling 21 RHINO-LARYNGO-BRONCHO FIBERSCOPE units because the instruction manual contains incorrect sterilization information for the STERIS System 1E, which may compromise sterility.

    Product
    Karl Storz RHINO-LARYNGO-BRONCHO FIBERSCOPE, Model # 11005BC1
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Devices)·Z-1549-2020·2020-04-01

    Mavidon Recalls PediaPrep Tubes and Cups Due to Bacterial Contamination

    Mavidon is recalling PediaPrep Tubes and Single use cups because samples were found contaminated with Burkholderia cepacia during an FDA inspection.

    Product
    PediaPrep Tubes (MD0033-T) and Single use cups (MD0033-SUP)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1563-2020·2020-04-01

    LivaNova VNS Therapy Programmer Recall Due to False Positive Warning Risk

    LivaNova is recalling 2,683 VNS Therapy Programmer Model 3000 units because a specific sequence of actions may trigger a false positive warning, potentially leading to unnecessary medical intervention.

    Product
    VNS Therapy Programmer, Model 3000 used with Models 103, 104, 105, 106, or 8103 VNS Therapy generators.
    Category
    Medical Device
    Distribution
    50 states
  • HighFDA (Devices)·Z-1559-2020·2020-04-01

    Intellijoint Navigation System Software Recalled for Incorrect Knee Surgery Calculations

    Intellijoint Surgical is recalling its Navigation System software because it may incorrectly calculate femur resection depth during total knee arthroplasty.

    Product
    Intellijoint Navigation System, Software Application, IJK1 (P/N 000-0547) - Product Usage: The Intellijoint Navigation System is a computer-controlled, optical localizer intended to provide intra-operative measurements to a surgeon to aid in selection and positioning of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1586-2020·2020-04-01

    Medtronic MiniMed Paradigm Insulin Pumps Recalled for Cybersecurity Vulnerability

    Medtronic MiniMed is recalling 73,028 Paradigm insulin pumps due to cybersecurity vulnerabilities that could allow unauthorized wireless control of insulin delivery.

    Product
    Medtronic MiniMed Paradigm Insulin pump, model numbers MMT 515 and MMT-715
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1550-2020·2020-04-01

    Mavidon CardioPrep Single Recalled Due to Burkholderia cepacia Contamination

    Carroll-Baccari, Inc. is recalling Mavidon CardioPrep Single products because samples were found contaminated with Burkholderia cepacia.

    Product
    MVAP MEDICAL SUPPLIES INC, Mavidon CardioPrep Single, 24 use cups, Re order # MCP-24
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1530-2020·2020-04-01

    Karl Storz Flexible Pediatric Neuroscopes Recalled Due to Sterilization Manual Error

    Karl Storz Endoscopy is recalling 73 flexible pediatric neuroscopes because the instruction manual contains incorrect sterilization information for the STERIS System 1E, which may compromise sterility.

    Product
    Karl Storz NEURO-FIBERSCOPE, Model # 11282BN1, Flexible Pediatric Neuroscope
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Devices)·Z-1545-2020·2020-04-01

    Medline Recalls Winged Sponges Due to Packaging Seal Voids

    Medline Industries is recalling 117,874 units of Winged Sponges Presaturated W/PVP because voids in the packaging seal caused a loss of sterility.

    Product
    Medline Winged Sponges Presaturated W/PVP REF DYND70289 DYND70289H Expiration 06/30/2022.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1594-2020·2020-04-01

    Medtronic MiniMed Paradigm Insulin Pump Recalled for Cybersecurity Vulnerabilities

    Medtronic MiniMed is recalling 72,850 Paradigm insulin pumps due to cybersecurity vulnerabilities that could allow unauthorized wireless control of insulin delivery.

    Product
    Medtronic MiniMed Paradigm Insulin pump, model number MMT-723
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1585-2020·2020-04-01

    Medtronic MiniMed Paradigm Insulin Pump Recalled for Cybersecurity Vulnerability

    Medtronic MiniMed is recalling 36,143 Paradigm insulin pumps due to a cybersecurity vulnerability that could allow unauthorized wireless control of insulin delivery.

    Product
    Medtronic MiniMed Paradigm Insulin pump, model number MMT-712E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1569-2020·2020-04-01

    Skytron Monitor Bracket Recalled for Weld Failure Risk

    Skytron is recalling 43 monitor brackets because a weld may fail, causing the display to fall and potentially injure users.

    Product
    Skytron Ergon 3 Series Skyboom Monitor Bracket-Flatscreen Bracket, single monitor mount, 27" max. screen size Part number 3FCM1
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-1548-2020·2020-04-01

    Carroll-Baccari Recalls LemonPrep Tubes and Cups Due to Bacterial Contamination

    Carroll-Baccari, Inc. is recalling LemonPrep Tubes and Single use cups because samples tested positive for Burkholderia cepacia during an FDA inspection.

    Product
    LemonPrep Tubes (MD0019-T) and Single use cups (MD0019-SUP)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1564-2020·2020-04-01

    Capintec Captus 4000e Thyroid Uptake System Recall for Collimator Defect

    Capintec is recalling Captus 4000e Thyroid Uptake Systems because insufficiently tapped screw holes may allow the collimator assembly to fall and contact patients or operators.

    Product
    Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1558-2020·2020-04-01

    Abbott FreeStyle Precision H Blood Glucose and Ketone Meter Recall

    Abbott is recalling FreeStyle Precision H meters because unapproved instructions for disinfection and multi-patient use may lead to infection.

    Product
    FreeStyle Precision H Blood Glucose and Ketone Monitoring System, UDI: 00093815711810
    Category
    Medical Device
    Distribution
    32 states
  • CriticalFDA (Devices)·Z-1499-2020·2020-03-25

    Philips Recalls HeartStart MRx Defibrillators Due to Internal Damage Risk

    Philips is recalling HeartStart MRx Monitor/Defibrillators because internal damage from drops or shocks may prevent therapy delivery, even if the device appears undamaged.

    Product
    HeartStart MRx Monitor/Defibrillators with model numbers M3535A M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, and M3536M9.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1474-2020·2020-03-25

    CME America BodyGuard Infusion Pump Systems Recalled for Delivery Inaccuracy

    CME America is recalling BodyGuard Infusion Pump Systems because they may deliver drugs at inaccurate rates, potentially causing faster or slower than expected medication administration.

    Product
    CME America BodyGuard Infusion Pump System, All models of BG 323, BG 121, BG 545, BG CV545, BG 575, BG CV575, and CMExpress
    Category
    Medical Device
    Distribution
    45 states
  • SevereFDA (Devices)·Z-1506-2020·2020-03-25

    TeDan Surgical Innovations Recalls Quick Start Distraction Screws Due to Packaging Damage

    TeDan Surgical Innovations is recalling sterile distraction screws because damaged packaging may have exposed them to non-sterile conditions, posing an infection risk.

    Product
    DS-0024 QUICK START DISTRACTION SCREW 14MM 5/BOX STERILE - Product Usage: These products are intended to be used by trained surgeons and are designed for use with TSI distractors and screwdrivers.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1508-2020·2020-03-25

    Stryker Strykeprobe Outer Sheath Recalled for Potential Electrical Hazard

    Stryker is recalling 525 Strykeprobe Outer Sheath Replacement devices due to a potential length mismatch that could cause sheath melting and unintended electrical flow to patients.

    Product
    Stryker, REF: 0250070460, 5.0 mm x 32 cm, Strykeprobe, Outer Sheath Replacement, RX Only, Non-Sterile, CE, UDI: (01) 07613327051971 These products are distributed with the following sheath/probe: 0250070441-PKG, StrykeFlow Electrocautery Probe, Spatula Tip 5MM…
    Category
    Medical Device
    Distribution
    0 states