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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13576–13600 of 31490

  • SevereFDA (Devices)·Z-1680-2024·2024-05-22

    Expo 5F Selective Angiographic Catheters Recalled for Material Delamination

    Boston Scientific is recalling Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination and material detachment that can prevent guidewire advancement during cardiac procedures.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR1 (5PK), REF H74908526842; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1660-2024·2024-05-22

    Expo 5F Cardiac Catheters Recalled for Polyurethane Delamination and Guidewire Advancement Failure

    Boston Scientific recalls Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination and material detachment. The defect prevents guidewire advancement through 1065 affected devices distributed worldwide.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IM 125CM (5PK), REF H749085262402; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1656-2024·2024-05-22

    Selective Angiographic Catheters Recalled Due to Material Delamination

    Boston Scientific recalls Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination and material detachment in the catheter lining, which may prevent guidewire advancement during medical procedures.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 125CM (5PK), REF H749085262252; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1649-2024·2024-05-22

    Cardiac Catheters Recalled Due to Material Delamination and Guidewire Failure

    Boston Scientific is recalling Expo 5F cardiac catheters due to material delamination in the inner lining that prevents guidewire advancement. The defect affects 25,617 units distributed worldwide.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IM (5PK), REF H749085262012; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1640-2024·2024-05-22

    Expo 5F Selective Angiographic Catheters recalled due to material delamination

    Boston Scientific Corporation is recalling Expo 5F Selective Angiographic Catheters in certain batches due to polyurethane layer delamination that prevents guidewire advancement. The inner lining material may detach, making the catheters unsafe to use.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 (SGL), REF H74908526031; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1655-2024·2024-05-22

    Expo 5F Selective Angiographic Catheters Recalled for Material Delamination

    Boston Scientific recalled Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination and material detachment in certain batches, which can prevent guidewire advancement during cardiac procedures.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4 (5PK), REF H74908526222; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1669-2024·2024-05-22

    Expo 5F Selective Angiographic Cardiac Catheters: Guidewire Advancement Failure Risk

    Boston Scientific is recalling certain batches of Expo 5F Selective Angiographic Cardiac Catheters due to polyurethane delamination that prevents guidewire advancement. The recall affects 15,270 units distributed worldwide.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 155 (5PKX3), REF H749085263022; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1641-2024·2024-05-22

    Boston Scientific Cardiac Catheters Recalled Due to Guidewire Advancement Failure

    Boston Scientific is recalling Expo 5F Selective Angiographic Catheters due to polyurethane delamination and material detachment that may prevent guidewire advancement. The recall affects 15,079 catheters distributed worldwide.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 (5PK), REF H74908526032; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1644-2024·2024-05-22

    Selective Angiographic Catheters recalled for material delamination and detachment

    Boston Scientific is recalling certain Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination and material detachment. The defect may prevent proper guidewire advancement during cardiac procedures.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL3 (5PK), REF H749085261002; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1650-2024·2024-05-22

    Expo 5F Selective Angiographic Catheters Recalled for Material Delamination

    Boston Scientific is recalling certain batches of Expo 5F Selective Angiographic Catheters due to polyurethane delamination and material detachment in the catheter's inner lining, which prevents proper advancement of the guidewire.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IMT (5PK), REF H749085262022; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1677-2024·2024-05-22

    Cardiac Catheters Recalled Due to Defective Polyurethane Layer

    Boston Scientific recalls 1,015 Expo 5F selective angiographic catheters due to polyurethane layer delamination that prevents guidewire advancement. The defect affects multiple batches distributed worldwide.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS3 (5PK), REF H74908526573A2; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1798-2024·2024-05-22

    Medtronic Tourniquet Sets recalled for potential unsealed sterile packing

    Medtronic is recalling 1760 tourniquet kits due to potential for unsealed sterile packing. These surgical devices may have compromised sterilization barriers.

    Product
    Medtronic Tourniquet Sets: a) DLP¿ 5.5 in (14.0 cm) Tourniquet Kit, Model Number 79004, b) DLP¿ 7 in (17.8 cm) Tourniquet Kit, Model Number 79009
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1796-2024·2024-05-22

    Medtronic Arteriotomy Cannula Recall Due to Potential Unsealed Sterile Packing

    Medtronic is recalling 7,935 units of I.M.A. Arteriotomy Cannula Model 31001 worldwide due to potential for unsealed sterile packing. Affected healthcare providers should verify lot numbers against inventory.

    Product
    Medtronic I.M.A. Cannulae: DLP¿ 1 mm Arteriotomy Cannula, Model Number 31001
    Category
    Medical Device
    Distribution
    0 states
  • 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-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 (Food)·F-1242-2024·2024-05-22

    Canned Jalapenos Recalled Due to Glass Contamination Hazard

    M-C McLANE INTERNATIONAL is recalling canned jalapenos due to potential glass contamination. The voluntary recall affects 2991 cases distributed across 27 states.

    Product
    Jalapenos packed in 6lb 10oz cans. 6 cans per case
    Category
    Food
    Distribution
    0 states
  • 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-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-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-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-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
  • 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-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-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-1793-2024·2024-05-22

    Medtronic Arterial Cannulae Recalled Due to Unsealed Sterile Packaging

    Medtronic Perfusion Systems is recalling multiple arterial cannula models worldwide due to potential for unsealed sterile packing. Compromised packaging may allow contamination of devices intended for clinical use.

    Product
    Medtronic Arterial Cannulae packaged as: a) DLP¿ Curved Metal Tip Arterial Cannula 20 Fr., Model Number 80020; b) DLP¿ Curved Metal Tip Arterial Cannula 20 Fr., Model Number 80220; c) DLP¿ Curved Metal Tip Arterial Cannula 20 Fr., Model Number 82020; d) DLP¿ Curved Metal
    Category
    Medical Device
    Distribution
    0 states