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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6501–6525 of 13666

  • HighFDA (Devices)·Z-1835-2024·2024-05-22

    Cardinal Health Curity Adhesive Bandages Recalled for Latex Contamination

    Cardinal Health is recalling Curity Flexible Adhesive Bandages (Model 44102, Lot #A14722) due to potential contamination with latex adhesive residual. The hypoallergenic product was distributed nationwide to approximately 2,000 packages.

    Product
    CardinalHealth Curity Flexible Adhesive Bandage X-Large 2 x 3.75 in. (5.1 x 9.5 cm), Model 44102, Sterile, Hypoallergenic.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1829-2024·2024-05-22

    MRI System Software May Fail to Warn of Inadequate Ventilation

    Philips Ingenia 1.5T MRI systems with software R5.7.1 may not provide adequate warning for low ventilation conditions, potentially causing increased patient body temperature or burning sensation.

    Product
    Ingenia 1.5T with Evolution Upgrade 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device REF: 782116
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1830-2024·2024-05-22

    Philips Ingenia 3.0T MR Systems May Not Warn of Low Ventilation Settings

    Philips Ingenia 3.0T MR systems with software R5.7.1 may fail to warn about low ventilation, potentially causing patient overheating or burning sensations. 19 units affected worldwide.

    Product
    Ingenia 3.0T with Evolution Upgrade 3.0T - - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device REF: 782117
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1790-2024·2024-05-22

    Prosthetic Knee Firmware Defect Risks Unintended Shutdown and Patient Falls

    The RKNXC0005 RHEO KNEE XC prosthetic knee may experience firmware issues causing unintended warnings and device shutdown, creating a fall risk for patients.

    Product
    RKNXC0005, RHEO KNEE XC 5 YR WARRANTY, MD, CE, External lower limb prosthetic component
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1832-2024·2024-05-22

    EchoTip Ultra HD Endoscopic Ultrasound Access Needle recalled for elevated bacterial endotoxin

    Cook Medical has recalled EchoTip Ultra HD Endoscopic Ultrasound Access Needles (lots C2145003, C2144407) due to elevated levels of bacterial endotoxin. The devices were distributed internationally in Germany, Netherlands, Switzerland, and the United Kingdom.

    Product
    EchoTip¿ Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1789-2024·2024-05-22

    Ossur RHEO Knee XC Prosthetic Components Recall Due to Firmware Issues

    Ossur is recalling 107 RHEO Knee XC prosthetic components due to firmware issues that may cause unintended device shutdown or warnings, risking patient falls.

    Product
    RKNXC0003, RHEO KNEE XC 3 YR WARRANTY, MD, CE, External lower limb prosthetic component
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1802-2024·2024-05-22

    Medtronic Disposable Pressure Display Sets recalled for unsealed sterile packaging

    Medtronic Perfusion Systems recalls 1,624 Disposable Pressure Display Sets (Models 61000 and 62000) distributed worldwide due to potential for unsealed sterile packing. No illnesses or injuries have been reported.

    Product
    Medtronic Disposable Pressure Display Sets: a) DLP¿ 114.3 cm (45 in), Model Number 61000; b) DLP¿ 114.3 cm (45 in), Model Number 62000
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1806-2024·2024-05-22

    MEDLINE namic Cardiovascular Kit Variants Recalled for Lack of Sterility

    Medline Industries recalls multiple namic CONVENIENCE KIT variants used in cardiovascular procedures due to lack of sterility assurance. Approximately 570 units distributed nationwide may pose infection risk.

    Product
    namic CONVENIENCE KIT, a) CAROTID MANIFOLD KIT, REF 60011045; b) 3V MANIFOLD KIT ON WITH NAMIC DT & WASTE MANAGEMENT, REF 60070582; c) LEFT HEART KIT, REF 60071822; d) LEFT HEART KIT, REF 60080085; e) CONVENIENCE KIT, REF 60100055; f) CONVENIENCE KIT, REF 60101041;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1826-2024·2024-05-22

    Sophysa Pressio Ventricular ICP Monitoring Kit Recalled for Manufacturing Defect Causing CSF Leakage

    Sophysa is recalling the Pressio Ventricular Intracranial Pressure Monitoring Kit due to a manufacturing defect that causes cerebrospinal fluid leakage. An undetected leak during implantation could pose an infectious risk to patients.

    Product
    The Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monitoring intracranial ventricular pressure and temperature with tunneling (PSO-VTT) indicated for use in intraventricular pressure monitoring and cerebrospinal fluid drainage applic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1818-2024·2024-05-22

    Free T3 Reagent Pack May Produce Inaccurate Test Results

    QUIDELORTHO's VITROS Free T3 Reagent Packs may produce falsely elevated test results, potentially affecting thyroid function diagnoses and patient management. Eight lot numbers with expiry dates through August 2024 were distributed worldwide.

    Product
    VITROS Immunodiagnostic Products Free T3 Reagent Pack-IVD is for the quantitative measurement of free triiodothyronine (FT3) in human serum and plasma (EDTA or heparin). Product Code: 131 5589
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1827-2024·2024-05-22

    Philips Patient Information Center iX Software: Event Catalog Data Loss Recall

    Philips Patient Information Center iX software version 4.x fails to properly save or transfer event catalog information, risking data loss in healthcare facilities. The FDA issued a Class II recall affecting 358 units globally.

    Product
    Patient Information Center iX and Patient Information Center iX Expand, Software Version 4.x.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1834-2024·2024-05-22

    Reagent Test Strips for Urinalysis Recalled Due to Missing Leukocytes Pad

    Macherey Nagel urinalysis test strips are recalled due to a missing leukocytes test pad on some packages, potentially resulting in false negative results for urinary tract infections and renal inflammation. Affected lot: 65402.

    Product
    Reagent Test Strips for Blood, Urobilinogen, Bilirubin, Protein, Nitrite, Ketones, Ascorbic Acid, Glucose, pH, Specific Gravity and Leucocytes in Urine by the Dip and Read Technique.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1809-2024·2024-05-22

    Karl Storz Laser Surgical Instruments Recalled Due to Sterilization Concerns

    Karl Storz laser surgical instruments lack validated sterilization procedures, creating infection risk after reprocessing. The FDA has recalled 85 units distributed nationwide and in Argentina.

    Product
    LASER Application Instrument, 23 cm, REF: 8694; LEUNIG-GREVERS LASER Application, REF: 461000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1792-2024·2024-05-22

    TriMed Threaded IM Nails Recalled Due to Out-of-Spec Driver-Socket Defect

    TriMed Threaded IM Nail 3.6mm implants are being recalled due to a driver-socket defect that could prevent proper nail pickup or torque application. The recall affects 120 units from lot QM23087 distributed nationwide.

    Product
    TriMed, Threaded IM Nail 3.6mm, 60mm, TI, Ref: IMN3.6-60 T, Non Sterile, MD, Rx Only TriMed, Threaded IM Nail 3.6mm, 65mm, TI, Ref: IMN3.6-65 T, Non Sterile, MD, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1825-2024·2024-05-22

    Sophysa Pressio Ventricular Intracranial Pressure Monitoring Kit Recall Due to CSF Leakage Risk

    Sophysa is recalling the Pressio Ventricular Intracranial Pressure Monitoring Kit due to manufacturing defects causing cerebrospinal fluid leakage from the catheter. Undetected leaks during implantation could result in infection risk to patients.

    Product
    The Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monitoring intracranial ventricular pressure with tunneling (PSO-VT) indicated for use in intraventricular pressure monitoring and cerebrospinal fluid drainage application. Model/Cat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1805-2024·2024-05-22

    Medtronic Venous Cannulae Recalled for Unsealed Sterile Packaging

    Medtronic Perfusion Systems is recalling 17,221 units of venous cannulae due to potential for unsealed sterile packaging. The devices were distributed worldwide to healthcare facilities.

    Product
    Medtronic Venous Cannulae: a) DLP¿ 20 Fr. Malleable Single Stage Venous Cannula, Model Number 68120, b) DLP¿ 24 Fr. Malleable Single Stage Venous Cannula, Model Number 68124, c) DLP¿ 28 Fr. Malleable Single Stage Venous Cannula, Model Number 68128, d) DLP¿ 30 Fr. Malleab
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1788-2024·2024-05-22

    Prosthetic knee recalled due to firmware defect causing device shutdown

    Ossur RHEO KNEE prosthetic units recalled due to firmware issues causing unintended warnings and device shutdown, which could result in patient falls.

    Product
    RKN130003, RHEO KNEE 3 YR WARRANTY, MD, CE, External lower limb prosthetic component
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1823-2024·2024-05-22

    Airvo 2 and myAirvo 2 Humidifiers: Alarm Speaker Defect Recall

    Fisher & Paykel's Airvo 2 and myAirvo 2 respiratory humidifiers have a speaker defect that may silence or distort critical alarm sounds. If the alarm fails and therapy is interrupted, patients could experience oxygen desaturation.

    Product
    Airvo 2 Humidifier, REF: PT101US, and myAirvo 2 Humidifier, REF: PT100US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1801-2024·2024-05-22

    Medtronic Cardioplegia Adapters recalled for potential unsealed sterile packaging

    Medtronic is recalling seven models of cardioplegia adapters due to potential unsealed sterile packaging, which could compromise equipment sterility in cardiac surgery. No illnesses have been reported.

    Product
    Medtronic Cardioplegia Adapters: a) DLP¿ 1.8 m (6 ft) Pressure Monitoring Extension Line Adapter, Model Number 25009, b) DLP¿ 1.8 m (6 ft) Pressure Monitoring Extension Line Adapter, Model Number 25010, c) DLP¿ 30.5 cm (12 in) Multiple Perfusion Set, Model Number 14003,
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1833-2024·2024-05-22

    Cook Medical EchoTip Ultra needle recalled due to elevated bacterial endotoxin levels

    Cook Medical is recalling EchoTip Ultra endoscopic ultrasound access needles that may contain elevated bacterial endotoxin levels. The affected units were distributed internationally.

    Product
    EchoTip¿ Ultra Endoscopic Ultrasound Access Needle, ECHO-19, G31520
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1831-2024·2024-05-22

    CARDIOHELP-i System Recalled for Elevated Patient Leakage Current

    Maquet Medical Systems USA is recalling the CARDIOHELP-i System because measured patient leakage current in some units significantly exceeded expected safety levels.

    Product
    CARDIOHELP-i System. Blood oxygenation and carbon dioxide removal system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1822-2024·2024-05-22

    Novalung Sensor Box Recalled for Flow Measurement Technical Failure

    Fresenius is recalling 88 Novalung sensor boxes for error messages affecting flow measurement. The defect impacts measurement capabilities in a life-support system used for acute respiratory and cardiac failure patients.

    Product
    Novalung sensor box is a component of the Novalung Console (F30000162)-Indicated for long-term (> 6 hours) respiratory/ cardiopulmonary support that provides assisted extracorporeal circulation and physiologic gas exchange (oxygenation and CO2 removal) of the patient's blood in a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1787-2024·2024-05-22

    Prosthetic knee recalled due to firmware issues causing potential device shutdown

    Ossur H/F is recalling RHEO KNEE prosthetic knee components due to firmware issues that could cause unintended warnings and device shutdown, creating fall risk for users.

    Product
    RKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic component
    Category
    Medical Device
    Distribution
    Distributed nationwide