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.

Filters

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All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

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All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

11101–11125 of 13717

  • HighFDA (Devices)·Z-1709-2022·2022-09-21

    Roadrunner PC Wire Guide Recalled for Sterility Testing Failure

    Cook Incorporated is recalling 1,997 units of the Roadrunner PC Hydrophilic Wire Guide due to packaging failure in sterility testing. The device's sterility may be compromised.

    Product
    Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): RPC-35-180 ORDER NUMBER (GPN):G07518. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1723-2022·2022-09-21

    ICU Medical IV Connector Extension Set Recalled for Manufacturing Defect

    ICU Medical is recalling intravascular administration set connectors due to a manufacturing defect that creates a visible gap in the connector housing. The defect affects approximately 5.8 million units distributed nationwide and internationally.

    Product
    6.5 IN (17 cm) APPX 0.78 ml, EXT SET w/Clave CLEAR, Clave 4-WAY Stopcock, Spiros, RED CAP. Accessory for intravascular administration set.
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-1750-2022·2022-09-21

    Surpria 64 Software Error May Prevent Image Reconstruction During Scanning

    Surpria 64 CT scanner software versions V3.11 and V3.22 may encounter errors that prevent image reconstruction, requiring repeat scans that expose patients to additional radiation. 16 units nationwide are affected.

    Product
    Surpria 64: Software Version V3.11, V3.22
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1722-2022·2022-09-21

    ICU Medical Recalls Intravascular Connectors for Manufacturing Defect

    ICU Medical is recalling approximately 5.8 million MicroClave Clear Connectors used in IV administration due to a manufacturing defect that creates a visible gap between the connector housing.

    Product
    MicroClave Clear Neutral Connector; MicroClave Clear Connector; MicroClave Clear Neutral Connector, Approx Priming Volume: 0.04 mL. Accessory for Intravascular Administration Set
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-1718-2022·2022-09-21

    Cook Roadrunner Hydrophilic Wire Guide Recalled for Potential Sterility Compromise

    Cook Incorporated is recalling the Roadrunner UniGlide Hydrophilic Wire Guide due to failed packaging sterility testing. The device's sterility may be compromised.

    Product
    Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWS-35-80 ORDER NUMBER (GPN): G56151. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1746-2022·2022-09-21

    Laboratory device displays incorrect sample volume guidance during setup

    A laboratory automation device's setup screen indicates minimal volume when the exact volume should be loaded, potentially causing over-diluted, under-diluted, or improperly prepared samples and false test results.

    Product
    QIAcube Connect MDx, Model No. 9003070
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-1744-2022·2022-09-21

    Pinnacle3 Radiation Therapy Planning System dose-calculation software error

    Philips Pinnacle3 radiation therapy planning systems may export incorrect dose information when multiple beams are used with certain Edit Prescription settings. 169 systems are affected.

    Product
    Pinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237.
    Category
    Medical Device
    Distribution
    21 states
  • HighFDA (Devices)·Z-1749-2022·2022-09-21

    FUJIFILM Surpria Imaging Software May Fail During Scanning

    Surpria software versions V3.11 and V3.22 may encounter processing errors that prevent image reconstruction, potentially requiring additional scans and exposing patients to unnecessary radiation.

    Product
    Surpria: Software Version V3.11, V3.22
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1735-2022·2022-09-21

    Stryker USB Converter in Mako Robotic Surgery System May Fail

    Mako Surgical Corporation is recalling certain Stryker USB Converter components that may arrive non-functional or fail during use. Affected units are in Illinois and Arizona.

    Product
    Stryker USB Converter, Polaris Spectra Camera, Catalog #201148, a component of the Mako Robotic-Arm Assisted Surgery System.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1741-2022·2022-09-21

    PTS Panels CHOL+GLU Test Strips Recalled for Incorrect Instructions

    PTS Panels CHOL+GLU Test Strips (lot A202) are recalled because incorrect instructions for use were packaged with the product. Distribution includes the US, Japan, and Russia.

    Product
    PTS Panels CHOL+GLU Test Strips (REF 1765)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1736-2022·2022-09-21

    Steris SixCess Challenge Pack Recalled for Incorrect Chemical Indicators

    Steris Corporation is recalling 619 boxes of Verify SixCess Challenge Pack due to incorrect chemical indicators in the packaging. This sterilization validation device is distributed across 31 U.S. states.

    Product
    Verify SixCess Challenge Pack. Used to confirm that critical parameters of steam sterilization have been reached within a challenging test pack design.
    Category
    Medical Device
    Distribution
    31 states
  • ModerateFDA (Devices)·Z-1733-2022·2022-09-21

    GXL Hip Implant Liners Recalled for Packaging Defect Risk

    Exactech is recalling specific GXL acetabular polyethylene hip implant liners because non-conforming packaging may cause accelerated wear. The company has distributed 4,956 affected devices worldwide.

    Product
    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 42, REF 106-22-42; b. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 44, REF 106-22-44; c. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1729-2022·2022-09-21

    GXL Acetabular Liners Recalled Due to Non-Conforming Packaging

    Exactech is recalling certain GXL acetabular liners packaged in non-conforming bags that may cause accelerated wear of the hip implant component. No injuries have been reported.

    Product
    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER, NEUTRAL, 28MM ID, GROUP 1 CUPS, REF 130-28-51 b. NOVATION GXL LINER, NEUTRAL, 32MM ID, GROUP 2 CUPS, REF 130-32-52 c. NOVATION GXL LINER, NEUTRAL, 36MM ID, GROUP 3 CUPS, RE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1740-2022·2022-09-21

    Helix Elite SARS-CoV-2 Reference Standard Recalled for Unregistered UK Distribution

    Microbiologics Inc. has recalled Helix Elite Inactivated SARS-CoV-2 reference standards distributed to the United Kingdom because the product was not registered for use in that region.

    Product
    Helix Elite Inactivated Standard, labeled as: a. Inactivated SARS-CoV-2 B.1.1.7 Whole Virus, REF HE0071N; b. Inactivated SARS-CoV-2 B.1.351 Whole Virus, REF HE0073N
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1655-2022·2022-09-14

    Philips BiPAP A40 Respiratory Devices Recalled for Motor Assembly Off-Gassing

    Philips is recalling BiPAP A40 respiratory support devices because motor assemblies were manufactured with nonconforming plastic that off-gases volatile organic compounds (VOCs). Approximately 1,414 units have been distributed domestically and internationally.

    Product
    Philips BiPAP A40, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
    Category
    Medical Device
    Distribution
    42 states
  • SevereFDA (Devices)·Z-1658-2022·2022-09-14

    Philips OmniLab Advanced+ Ventilation Devices Recalled for Plastic Off-Gassing

    Philips Respironics is recalling certain Philips OmniLab Advanced+ noninvasive ventilation devices due to motor assemblies with nonconforming plastic that can off-gas volatile organic compounds (VOCs). This is an FDA Class I recall.

    Product
    Philips OmniLab Advanced+ Intl (Flow Gen), Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
    Category
    Medical Device
    Distribution
    42 states
  • SevereFDA (Devices)·Z-1659-2022·2022-09-14

    Philips OmniLab ventilator recalled for motor assembly plastic off-gassing defect

    Philips Respironics is recalling OmniLab Advanced + ventilators due to motor assemblies manufactured with nonconforming plastic that releases volatile organic compounds (VOCs). The 8 affected units were distributed across the US and internationally.

    Product
    Philips OmniLab Advanced + with Heated Tube Humidifier, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
    Category
    Medical Device
    Distribution
    42 states
  • SevereFDA (Devices)·Z-1656-2022·2022-09-14

    Philips BiPAP V30 Auto Respirators Recalled for VOC Off-Gassing Risk

    Philips Respironics recalls 295 BiPAP V30 Auto respiratory devices due to motor assemblies with nonconforming plastic. These assemblies off-gas volatile organic compounds (VOCs) during device operation.

    Product
    Philips BiPAP V30 Auto, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
    Category
    Medical Device
    Distribution
    42 states
  • SevereFDA (Devices)·Z-1657-2022·2022-09-14

    Philips OmniLab Advanced+ sleep apnea devices recalled for off-gassing

    Philips Respironics is recalling 85 units of the OmniLab Advanced+ ventilation device due to motor assemblies containing nonconforming plastic that off-gasses volatile organic compounds.

    Product
    Philips OmniLab Advanced+, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
    Category
    Medical Device
    Distribution
    42 states
  • SevereFDA (Devices)·Z-1654-2022·2022-09-14

    Philips BiPAP A30 respiratory device motor assemblies recalled for VOC off-gassing

    Philips Respironics recalls Philips BiPAP A30 respiratory devices due to motor assemblies with nonconforming plastic that off-gases volatile organic compounds (VOCs). Patients should contact the manufacturer immediately.

    Product
    Philips BiPAP A30, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-1676-2022·2022-09-14

    Laboratory diagnostic system may report inaccurate results during shutdown

    The VITROS XT 7600 laboratory analyzer may report inaccurate test results when the system performs a shutdown. The issue affects approximately 1,148 units distributed worldwide.

    Product
    VITROS XT 7600 Integrated System with Version 3.7.2 and below Product Code: 6844461
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1678-2022·2022-09-14

    External Fixation Wire May Fracture During Surgery, Leaving Fragments in Patient

    OrthoPediatrics Corp is recalling an external fixation wire due to manufacturing variance that may cause the tip to fracture. Fractured fragments could remain in patients.

    Product
    Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1696-2022·2022-09-14

    Port Insertion Packs Recalled Due to Unvalidated Sterilization

    American Contract Systems is recalling Various Port Insertion Packs that were exposed to multiple sterilization cycles without proper validation. The devices may not meet sterility standards.

    Product
    Various Port Insertion Packs
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1693-2022·2022-09-14

    ENT Surgical Packs Recalled Due to Sterilization Validation Failure

    American Contract Systems recalls various ENT surgical packs that may not have been properly sterilized due to multiple sterilization cycles without adequate validation. The packs were distributed to healthcare facilities in 13 states.

    Product
    Various ENT Packs
    Category
    Medical Device
    Distribution
    13 states