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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5401–5425 of 27375

  • SevereFDA (Devices)·Z-1659-2024·2024-05-22

    Expo selective angiographic cardiac catheters recalled for guidewire advancement failure

    Boston Scientific is recalling Expo 5F selective angiographic catheters due to polyurethane layer delamination and material detachment that prevents guidewire advancement through the device.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL5 125CM (5PK), REF H749085262352; 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-1643-2024·2024-05-22

    Cardiac catheters recalled due to polyurethane layer delamination defects

    Boston Scientific is recalling Expo 5F Selective Angiographic Catheters due to polyurethane layer defects that prevent proper guidewire insertion. Affected devices may experience material detachment in the catheter lining.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 MOD (5PK), REF H74908526052; 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
  • HighFDA (Devices)·Z-1807-2024·2024-05-22

    Medline Namic Fluid Delivery Set Recalled for Lack of Sterility Assurance

    Medline Industries is recalling Namic Fluid Delivery Sets (lot 0000113381) because they lack sterility assurance, which could allow contamination during medical procedures.

    Product
    Namic FLUID DELIVERY SET, REF 91300040
    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-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-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-1800-2024·2024-05-22

    Medtronic Aortic Root Cannulae and Cardioplegia Needles Recalled for Unsealed Sterile Packing

    Medtronic is recalling aortic root cannulae and cardioplegia needles used in cardiac surgery due to potential unsealed sterile packaging. Approximately 2,622 units were distributed worldwide.

    Product
    Medtronic Aortic Root Cannulae and Cardioplegia Needles: a) DLP¿ 9 Ga (11 Fr) Aortic Root Cannula, Model Number 24009; b) DLP¿ 16 Ga (5 Fr) Cardioplegia Needle Neonatal 0.64 cm (1/4 in) Tip Length, Model Number 11316; c) M+AR" 14 Ga (7 Fr) Aortic Root Cannula with Flow-
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1791-2024·2024-05-22

    TriMed Threaded IM Nail System Recalled for Driver-Socket Defect

    TriMed Inc. is recalling 142 units of Threaded IM Nails with an out-of-specification driver-socket that could prevent proper surgical nail fixation and torque application.

    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-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-1820-2024·2024-05-22

    HeartSine Public Access Defibrillators Recalled for Voice Prompt Manufacturing Defect

    Certain HeartSine PAD defibrillators may fail to deliver voice prompts during emergency use due to a manufacturing defect, potentially delaying therapy. Visual instructions remain available.

    Product
    HeartSine samaritan PAD (Public Access Defibrillator), Type: SAM 350P, SAM 360P, SAM 450P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-1810-2024·2024-05-22

    Baxter Spectrum IQ Infusion Pump Recalled for Potential Front Panel Cracks

    Baxter Healthcare Corporation has recalled 9 Spectrum IQ Infusion Pumps due to potential cracks on the front panel mount. Units distributed in Ohio and Wisconsin are affected.

    Product
    Spectrum IQ Infusion pump, Product Code 357009
    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-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-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-1797-2024·2024-05-22

    Medtronic Left Heart Vent Catheters recalled for unsealed sterile packaging

    Medtronic recalls over 13,000 Left Heart Vent Catheter units due to potential for unsealed sterile packing. Affected devices distributed worldwide.

    Product
    Medtronic Left Heart Vent Catheters: a) DLP¿ Intracardiac Sump 20 Fr, Model Number 12012, b) DLP¿ Left Heart Vent Catheter 10 Fr., Model Number 12008, c) DLP¿ Left Heart Vent Catheter 13 Fr., Model Number 12001, d) DLP¿ Left Heart Vent Catheter 13 Fr., Model Number 12113
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1828-2024·2024-05-22

    CoFlex NL Sterile Bandages Recalled for Packaging Seal Gaps

    Andover Healthcare Inc. is recalling CoFlex NL sterile flexible cohesive bandages (model 5400S) due to packaging seal gaps that could compromise product sterility. No illnesses have been reported.

    Product
    Sterile CoFlex NL: Latex Free Flexible Cohesive Bandage, Tan, 4INx5YD (5400S)
    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-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