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 27364

  • SevereFDA (Devices)·Z-0549-2024·2023-12-27

    Infusion pump recalled for mechanical valve interference interrupting therapy delivery

    Ivenix infusion pump may experience mechanical interference on fluid valve pins, interrupting therapy delivery. FDA recalled 938 units in five states due to potential risk of serious patient harm.

    Product
    Ivenix Infusion System (IIS), Large Volume Pump LVP-0004
    Category
    Medical Device
    Distribution
    5 states
  • SevereFDA (Devices)·Z-0514-2024·2023-12-27

    Sterile Water and Saline Products Recalled for Lack of Sterility Assurance

    Nurse Assist is recalling sterile water and saline irrigation products due to lack of sterility assurance. Use of nonsterile products could result in infection.

    Product
    Sterile Water/Saline: Product Name/Product Code: CUP STERILE WATER¿ FOIL LID 120 ML/T167005; CUP STERILE SALINE FOIL LID 120 ML/T167007
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0511-2024·2023-12-27

    IV Flush Syringes and Irrigation Solutions Recalled for Sterility Defect

    Nurse Assist, LLC recalls sodium chloride irrigation solutions and IV flush syringes due to potential lack of sterility assurance, which could allow contamination and infections.

    Product
    0.9% Sodium Chloride: Brand Name: Product Name/Product Code: MAC MEDICAL: 10ML FILL SYRINGE/9210; NURSE ASSIST: 3ML IV FLUSH SYRINGE/1203-BP, 5ML IV FLUSH SYRINGE/1205-BP, 10ML IV FLUSH SYRINGE/1210-BP; SOL: 0.9% SODIUM CHLORIDE IV FLUSH SYRINGE/PFF001; HALYARD OWENS MINOR: 0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0542-2024·2023-12-27

    AirFit F30i Full Face Mask Recalled Due to Magnetic Interference Risk

    ResMed is recalling the AirFit F30i Full Face Mask due to potential magnetic interference with active medical implants and ferromagnetic objects. Safety warnings are being updated.

    Product
    AirFit F30i Full Face Mask and User Guide
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0537-2024·2023-12-27

    AirFit F20 Full Face Mask recalled for magnetic interference with medical implants

    ResMed is recalling AirFit F20 Full Face Masks due to magnets that can interfere with active medical implants. Updated warnings will guide safe distances for patients and those in close contact.

    Product
    AirFit F20 Full Face Mask and User Guide
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0540-2024·2023-12-27

    AirTouch N20 Nasal Mask recalled for magnetic interference with medical implants

    ResMed is recalling 424,309 units of AirTouch N20 Nasal Masks because they contain magnets that may interfere with active medical implants and ferromagnetic materials. Updated safety warnings are being provided.

    Product
    AirTouch N20 Nasal Mask and User Guide
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0538-2024·2023-12-27

    AirTouch F20 Full Face Mask Recalled for Magnetic Interference with Medical Implants

    ResMed recalls 3.8 million AirTouch F20 full face masks with magnets that may interfere with active medical implants. Updated safety warnings regarding safe distances from medical devices are being issued.

    Product
    AirTouch F20 Full Face Mask and User Guide
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0539-2024·2023-12-27

    AirFit N20 Nasal Mask: Magnetic Interference with Medical Implants

    ResMed AirFit N20 Nasal Masks contain magnets that may interfere with active medical implants and ferromagnetic objects. The FDA classified this as Class I; ResMed is updating safety warnings with required distances.

    Product
    AirFit N20 Nasal Mask and User Guide
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0512-2024·2023-12-27

    Sodium Chloride IV Flush Kits Recalled for Potential Sterility Failure

    Nurse Assist recalls sodium chloride IV flush solutions due to potential loss of sterility assurance. Nonsterile solutions could cause infection when used for intravenous administration.

    Product
    0.9% Sodium Chloride: Product Name/Product Code: 10ML IV FLUSH STERILE FIELD/EMZ10091240
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0515-2024·2023-12-27

    Sterile Water Syringes recalled for lack of sterility assurance

    Nurse Assist LLC recalls sterile water injection and irrigation syringes for inadequate sterility assurance. Affected products may be nonsterile and could cause infection if used.

    Product
    Sterile Water: Product Name/Product Code: USP STERILE WATER SYRINGE/1030A, SYRINGE PREFILLED 10 ML/6496722, 30CC PREFILLED SYRINGE/6496723, USP STERILE WATER SYRINGE/1030, 10CC PREFILLED SYRINGES/51638, 30CC PREFILLED SYRINGES/52333, 10CC PREFILLED SYRINGES/1010
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0541-2024·2023-12-27

    AirFit F30 Full Face Mask recalled for magnetic interference with medical implants

    ResMed is recalling the AirFit F30 Full Face Mask because the device contains magnets that can interfere with active medical implants and ferromagnetic objects. The original user guide did not adequately warn about safe distance requirements.

    Product
    AirFit F30 Full Face Mask and User Guide
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0536-2024·2023-12-27

    ResMed AirFit N10 Nasal Masks Recalled for Magnetic Interference with Medical Implants

    ResMed is recalling AirFit N10 Nasal Masks because magnets in the masks may interfere with active medical implants. Patients with such implants should consult their healthcare provider before using these masks.

    Product
    AirFit N10 Nasal Masks and User Guide
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0601-2024·2023-12-27

    Siemens epoc NXS Blood Analysis System Software Causes Erroneous Test Results

    Siemens epoc NXS blood analysis systems have a software defect causing incorrect test results to be printed or transmitted. Results may include data from previous patients, potentially leading to misdiagnosis.

    Product
    epoc NXS Host Blood Analysis System, Siemens Material Numbers 11413497 (EU), 11413475 (US), 11413506 (CA), 11413517 (MX), 11413518 (ROW), 11413498 (JP), 11413583 (CN, KR), 11413879 (IN) with software versions from 4.9.4 to the current version 4.11.11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0604-2024·2023-12-27

    Abbott Hematology Analyzers Recalled for Unlabeled Latex Component

    Abbott CELL-DYN Ruby and Sapphire hematology analyzers contain latex that is not labeled on the device, posing a risk to users with latex allergies. The recall affects 670 devices distributed across 33 states, Puerto Rico, and Brazil.

    Product
    Abbott CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01, and Abbott CELL-DYN Sapphire, Model CD Sapphire, list number 08H00-01. Multi-parameter, automated hematology analyzer.
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0588-2024·2023-12-27

    Exactech Vantage Mobile Bearing Tibial Inserts Recalled Due to Vacuum Loss

    Exactech is recalling Vantage Mobile Bearing Tibial Inserts due to loss of vacuum in the innermost vacuum bag. Three complaints involving four devices have been reported.

    Product
    Exactech Vantage Mobile Bearing Tibial Inserts, Catalog Numbers: a) 350-41-23, b) 350-42-03
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-0610-2024·2023-12-27

    LITe Decompression Snake Arm cannot attach due to incorrect clamp component

    Stryker Spine is recalling 9 units of the LITe Decompression Snake Arm due to an incorrect clamp component that prevents proper attachment to the arm post shaft. Affected units were distributed in the US and internationally.

    Product
    LITe Decompression Snake Arm, REF 48080230
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0566-2024·2023-12-27

    CardioQuip Modular Cooler-Heater Model MCH-1000(m) Recalled for Bacterial Contamination

    CardioQuip LLC is recalling 2 units of its Model MCH-1000(m) Modular Cooler-Heater due to potential bacterial contamination that could result in patient infection. The affected devices are distributed in California, Texas, Pennsylvania, Washington, Ohio, and Nebraska.

    Product
    CardioQuip Modular Cooler-Heater, Model: MCH-1000(m), Power: 115V-60Hz, 16A
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-0587-2024·2023-12-27

    Exactech Vantage Ankle System Recalled Due to Vacuum Loss

    Exactech is recalling two catalog numbers of Vantage Ankle System devices due to loss of vacuum in the inner-most vacuum bag. Three complaints have been received relating to four affected devices.

    Product
    Exactech Vantage Ankle System, Catalog Numbers: a) 350-21-04, b) 350-22-03
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-0607-2024·2023-12-27

    RAPIDPoint 500 Diagnostic Cartridges Recall Due to Sodium Sensor Measurement Bias

    Siemens is recalling RAPIDPoint 500 measurement cartridges because the sodium sensor can produce inaccurate readings, potentially leading to delayed diagnosis or incorrect treatment of electrolyte imbalances.

    Product
    RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 250-Intended for in vitro diagnostic use and is designed to provide the determination in whole blood. SMN: 10491447
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0569-2024·2023-12-27

    Orthopedic implant head recall due to incorrect adapter in packaging

    Biomet's Biolox ceramic hip implant heads were shipped with the wrong adapter component. The adapter had an incorrect neck length (M/+0 instead of S/-3.0) that differs in size marking.

    Product
    Biolox Ceramic Option Head Zimmer 12/14 40mm -3, Item Number 00-8777-040-01
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0576-2024·2023-12-27

    Philips Inclusive CT Systems: Software Errors in Image Display and Interpretation

    Philips North America is recalling 330 Philips Inclusive CT imaging systems due to software issues causing incorrect image display, errors in image interpretation, and patient exposure to incorrect images and system functions during clinical use.

    Product
    The device is a whole-body CT x-ray system. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body taken at different angles and planes. The system also includes signal analysis and display equipment, patient and equipment suppor
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-0558-2024·2023-12-27

    Philips Allura Medical Imaging Systems Ceiling Mount May Fall

    Philips is recalling Allura imaging systems where the ceiling-mounted rotation cover may fall during equipment collisions, risking injury or sterility issues. Approximately 9,991 units are affected worldwide.

    Product
    Philips Allura systems with monoplane fixed ceiling mounts: 722001 Allura Xper FD10C 722003 Allura Xper FD10 722006 Allura Xper FD20 722010 Allura Xper FD10 722012 Allura Xper FD20 722015 Allura Xper FD20 OR Table 722016 Integris H5000 C / Allura 9C 722018 Integris Allur
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0580-2024·2023-12-27

    Exactech Equinoxe Shoulder System recalled for loss of vacuum

    Exactech is recalling specific models of its Equinoxe Shoulder System implants due to loss of vacuum in the inner-most vacuum bag. Four devices have been affected according to three complaints received.

    Product
    Exactech Equinoxe Shoulder System, Catalog Numbers: a) 314-23-02, b) 314-23-03, c) 314-23-13, d) 314-23-14, e) 314-23-15, f) 314-24-22, g) 314-24-23, h) 314-24-24, i) 314-24-32, j) 314-24-33, k) 314-24-34, l) 314-24-35
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-0577-2024·2023-12-27

    AcuMatch Hip System Recalled for Loss of Vacuum Integrity

    Exactech is recalling AcuMatch Hip System devices due to loss of vacuum in the inner-most vacuum bag, with 3 complaints reported affecting 4 devices. Vacuum loss could compromise device packaging integrity.

    Product
    AcuMatch Hip System, Catalog Number 142-32-27
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-0578-2024·2023-12-27

    Hip Implant Liner Recalled Due to Loss of Vacuum in Inner Bag

    Exactech has recalled certain Alteon Hip XLE Liner hip implant components due to vacuum loss in the inner vacuum bag. The company has received 3 complaints involving 4 devices related to this issue.

    Product
    Exactech Alteon Hip XLE Liner, Catalog Numbers: a) 01-030-40-0636, b) 01-030-40-0640, c) 01-030-42-0536
    Category
    Medical Device
    Distribution
    16 states