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 deaths or serious injuries are reported, 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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76–100 of 122

  • CriticalFDA (Devices)·Z-1947-2023·2023-07-05

    Preformed AGT Endotracheal Tubes Recalled Due to Connector Disconnection

    Teleflex is recalling 25,520 Preformed AGT endotracheal tubes due to reports of 15mm connector disconnection. This is an FDA Class I recall affecting units distributed nationwide.

    Product
    Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780070
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1927-2023·2023-07-05

    Endotracheal Tubes Recalled for Connector Disconnection Risk

    Teleflex LLC is recalling 2,860 endotracheal tubes due to reports of 15mm connector disconnection. Affected tubes were distributed nationwide including Puerto Rico.

    Product
    Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380035
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1898-2023·2023-07-05

    RUSCHELIT Safety Clear Tracheal Tube 15mm Connector Disconnection Recall

    TELEFLEX is recalling RUSCHELIT Safety Clear Tracheal Tubes due to reported disconnection of the 15mm connector, affecting approximately 37,076 units distributed nationwide.

    Product
    RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480040
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1882-2023·2023-07-05

    TELEFLEX Endotracheal Tubes Recalled Due to Connector Disconnection Risk

    TELEFLEX is recalling 760 endotracheal tubes due to reports of 15mm connector disconnection. This medical device failure could compromise airway management during critical care.

    Product
    Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080095
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1890-2023·2023-07-05

    Teleflex endotracheal tubes recalled for connector disconnection defect

    Teleflex LLC is recalling 170,179 endotracheal tubes nationwide due to reports of 15mm connector disconnection. The tubes are used for airway management in medical facilities.

    Product
    Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082080
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1999-2023·2023-07-05

    MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode Recalled for Patient Burns

    Megadyne Medical Products is recalling 21,100 units of MEGA SOFT Universal Plus Patient Return Electrodes used in electrosurgery. The FDA Class I recall follows reports of patient burns during surgical procedures.

    Product
    MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode. used during electrosurgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1828-2023·2023-07-05

    Teleflex Slick Set endotracheal tubes recalled for connector disconnection

    Teleflex Slick Set endotracheal tubes (REF 170055) are being recalled by the FDA following reports of disconnection of the 15mm connector. This Class I recall affects approximately 3,530 units distributed nationwide.

    Product
    Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170055
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1719-2023·2023-06-28

    Medtronic MIRRO MRI Implantable Defibrillator Recall for Potential Therapy Failure Risk

    Medtronic's MIRRO MRI implantable cardioverter defibrillators with a specific glassed feedthrough may rarely fail to deliver adequate energy output during high-voltage therapy, affecting approximately 2,831 units distributed worldwide.

    Product
    ICD-DR DDME3D1 MIRRO MRI, Model Number DDME3D1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1738-2023·2023-06-28

    Implantable Cardioverter Defibrillators at Risk of Reduced Energy Output During Therapy

    Certain implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators may fail to deliver adequate energy during high-voltage therapy due to a specific feedthrough defect. Medtronic is recalling 1,132 affected units.

    Product
    CRT-D DTBA2Q1 VIVA QUAD XT IS4/DF1 INTL, Model Number DTBA2Q1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1742-2023·2023-06-28

    Medtronic CRT-D Defibrillators: Rare Energy Output Failure Risk During Therapy

    Medtronic implantable cardioverter defibrillators (CRT-D) may deliver reduced or no energy during high-voltage therapy due to manufacturing defect in the feedthrough component. FDA Class I recall affects 182 units.

    Product
    CRT-D DTBB1D4 VIVA S IS1/DF4 US, Model Number DTBB1D4; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1755-2023·2023-06-28

    Implantable Cardioverter Defibrillators Risk Therapy Failure Due to Feedthrough Defect

    Medtronic implantable cardioverter defibrillators may fail to deliver critical therapy due to a feedthrough defect. The defect can cause reduced or absent energy output during high-voltage therapy in 8,602 affected units distributed worldwide.

    Product
    CRTD DTMA1Q1 CLARIA MRI QUAD US DF1, Model Number DTMA1Q1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1769-2023·2023-06-28

    Implantable Cardioverter Defibrillators Recalled for Potential High-Voltage Therapy Failure

    Medtronic is recalling 664 implantable cardioverter defibrillators due to a rare potential for reduced or no energy output during high-voltage therapy. The defect could prevent critical defibrillation therapy when needed.

    Product
    CRTD DTMC1D1 COMPIA MRI US DF1, Model Number DTMC1D1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1725-2023·2023-06-28

    Medtronic Implantable Cardioverter Defibrillators Recalled for Potential Therapy Failure

    Medtronic's ICD COBALT defibrillators may fail to deliver critical therapy due to a manufacturing defect in a power delivery component. Patients should contact their physician to determine if affected.

    Product
    ICD COBALT DR MRI IS1 DF1, Model Number DDPB3D1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1666-2023·2023-06-14

    StealthStation Cranial Software displays inaccurate navigation during brain surgery

    A software anomaly in Medtronic's StealthStation Cranial Software may cause inaccurate surgical navigation during brain procedures. This can result in unintended tissue damage and prolonged surgery.

    Product
    StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7 systems
    Category
    Medical Device
    Distribution
    1 state
  • CriticalFDA (Devices)·Z-1650-2023·2023-06-14

    Philips Trilogy and LifeVent ventilator models recalled for flow sensor debris

    Environmental debris accumulation may block flow sensors in Philips ventilators, potentially preventing accurate pressure and flow delivery to patients.

    Product
    Trilogy Evo O2 and LifeVent EVO2, Model Numbers DS2100X11B, IN2100X15B, IN2100X19, FX2100X15B, LA2100X15B, IA2100X15B, FP2100X10, FR2100X14B, ND2100X15B, IT2100X21B, ES2100X15B, DE2100X13B, EU2100X15B, EU2100X19, EE2100X15B, and SP2100X26B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1618-2023·2023-05-31

    Pediatric Ventricular Assist Device Blood Pumps Recalled for Potential Membrane Disruption

    BERLIN HEART GMBH recalls EXCOR Pediatric Ventricular Assist Device Blood Pumps due to potential disruption in triple-layer membranes. The 335 affected units were distributed to multiple US states and Canada.

    Product
    EXCOR Pediatric Ventricular Assist Device Blood Pumps, Models: P10P-001 (10 ml blood pump); P15P-001 (10 ml blood pump); P25P-001x01 (25 ml blood pump); P30P-001x01 (30 ml blood pump), P50P-001 (50 ml blood pump); P60P-001 (60 ml blood pump). Recall occurred in 2018, and was r
    Category
    Medical Device
    Distribution
    16 states
  • CriticalFDA (Devices)·Z-1447-2023·2023-05-24

    Draeger VentStar Anesthesia Breathing Circuit Connections May Detach

    Draeger Medical recalls VentStar Anesthesia (N) 180 breathing circuits. Glued connections can loosen or detach during ventilation, potentially creating a critical disconnection risk.

    Product
    VentStar Anesthesia (N) 180, MP00333
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1496-2023·2023-05-17

    Cordis Angioguard Emboli Capture Guidewire System Faces Separation Hazard

    Cordis's Angioguard RX/XP Emboli Capture Guidewire System is recalled due to potential separation of the delivery system and capture sheath, which could cause procedural delays, unplanned intervention, or stroke during use.

    Product
    ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RE
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-1148-2023·2023-03-15

    Cardiosave Rescue intra-aortic balloon pump may shut down unexpectedly

    The Cardiosave Rescue intra-aortic balloon pump may suddenly stop working due to communication failure between internal circuit boards, interrupting patient therapy and threatening hemodynamic stability.

    Product
    Cardiosave Rescue Model Nos. 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1056-2023·2023-02-15

    GE Nuclear Medicine Imaging Systems detector fall hazard

    GE Nuclear Medicine 600/800 series imaging systems may have faulty detectors that could fall, causing serious injury. Mitigation measures may not be properly implemented on 34 units distributed worldwide.

    Product
    GE Nuclear Medicine 600/800 series systems, specifically: a) OPTIMA O640 X 3/8 inch NR, b) DISCOVERY O640 X 3/8 inch, c) NM OPTIMA O640 X 3/8 inch, d) O640 NM Gantry 3/8 inch, e) O640 NM GANTRY FINAL ASSY, f) OPTIMA O640 X 3/8 inch; Emission Computed Tomography System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0886-2023·2023-01-25

    Cardiosave IABP may shut down unexpectedly due to blood contamination

    The Cardiosave Rescue Intra-Aortic Balloon Pump may shut down unexpectedly if blood enters the device through a compromised balloon catheter. Approximately 46 units have been distributed worldwide.

    Product
    Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85, 0998-UC-0800-75, 0998-UC-0800-83, 0998-UC-0800-85.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0438-2023·2022-12-21

    Arrow AC3 Optimus IABP recalled for shortened battery run-times

    Arrow AC3 Optimus Intra-Aortic Balloon Pump (IABP) devices are recalled worldwide due to a potential issue with shortened battery run-times. All lot and serial numbers of model IAP-0700 are affected.

    Product
    Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF IAP-0700 (IPN001112), cardiac pump
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0330-2023·2022-12-14

    Sensititre Medical Device Recall: False Antibiotic Susceptibility Test Results

    Remel Inc. is recalling Sensititre HPB1 diagnostic plates that may produce false susceptible results for specific bacteria when tested with seven antibiotics. This could lead to inaccurate susceptibility information affecting clinical treatment decisions.

    Product
    Thermo SCIENTIFIC, Sensititre HPB1, Gram Negative IVD AST
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0153-2023·2022-11-09

    CritiCool Thermoregulation Device Recalled Due to Pump Failure

    The CritiCool thermoregulation device may experience premature pump failure leading to a HALT 4 error from which the device cannot recover, potentially delaying treatment. One death has been reported.

    Product
    CritiCool, thermoregulation device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1522-2022·2022-08-31

    INTERA 3000 implantable pump recalled for higher-than-expected flow rate

    The FDA is recalling INTERA 3000 implantable hepatic infusion pumps due to a malfunction causing higher-than-expected medication flow rates. Patients should contact their healthcare provider.

    Product
    INTERA 3000 Hepatic Artery Infusion Pump, 30 mL, Sterile, Rx Only. implantable infusion pump.
    Category
    Medical Device
    Distribution
    13 states