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 the agency’s own highest classification or reported deaths or serious injuries, 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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22826–22850 of 40299

  • ModerateFDA (Devices)·Z-2889-2018·2018-08-29

    Ortho Kinematics Recalls Vertebral Motion Analyzer Software Due to Report Error

    Ortho Kinematics is recalling the Vertebral Motion Analyzer (VMA) software because a bug caused errors in the Radiological Read Report.

    Product
    Vertebral Motion Analyzer (VMA), 2.3.250. Product System, image processing, radiological
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2874-2018·2018-08-29

    BioMérieux VITEK 2 NH ID Test Kit Recalled for Missing Desiccant

    BioMérieux Inc. is recalling 57 cartons of VITEK 2 NH ID Test Kits because they are missing desiccant, which may affect product stability.

    Product
    bioM¿rieux VITEK 2 NH ID Test Kit Product Usage: Is an automated system consisting of instruments, software and reagent cards designed for the ID and antimicrobial susceptibility testing of bacteria and yeast.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2879-2018·2018-08-29

    In2Bones Recalls CoLink Lapidus Plates Due to Incorrect Laser Marking

    In2Bones USA, LLC is recalling 47 CoLink Lapidus Plate XP units because right and left plates were incorrectly laser-marked.

    Product
    CoLink(TM) Lapidus Plate XP, +2 mm, Right, REF P40 ST165, QTY 1, In2Bones Product Usage: The In2Bones USA LLC, CoLink¿ Plating System is indicated for stabilization and fixation of fractures, revision procedures, joint fusion, osteotomies and reconstruction of the small…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2883-2018·2018-08-29

    Smith & Nephew Recalls Mispackaged Genesis II Knee Prosthesis Components

    Smith & Nephew is recalling two lots of Genesis II knee prosthesis components because they were packaged with the wrong size and side.

    Product
    GENESIS II NON-POROUS CRUCIATE RETAINING FEMORAL COMPONENT, SIZE 6 RIGHT, REF 71420026 Knee prosthesis
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2880-2018·2018-08-29

    In2Bones Recalls CoLink Lapidus Plates Due to Incorrect Laser Marking

    In2Bones USA, LLC is recalling 48 units of CoLink Lapidus Plates because right and left plates were laser marked incorrectly.

    Product
    CoLink(TM) Lapidus Plate XP, +2 mm, Left, REF P40 ST265, QTY 1, In2Bones Product Usage: The In2Bones USA LLC, CoLink¿ Plating System is indicated for stabilization and fixation of fractures, revision procedures, joint fusion, osteotomies and reconstruction of the small…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2921-2018·2018-08-29

    Euro Diagnostica Anti-Cardiolipin ELISA Kits Recalled for Labeling Error

    Euro Diagnostica AB is recalling six lots of anti-cardiolipin ELISA kits due to an incorrect distribution label. The kits were distributed in Minnesota.

    Product
    is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of IgG and IgM autoantibodies specific for the phospholipid cardiolipin in human serum and EDTA, lithium heparin or citrated plasma. It is intended to assess anti-cardiolipin IgM…
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-2919-2018·2018-08-29

    Euro Diagnostica Anti-Ro ELISA Kits Recalled for Incorrect Labeling

    Euro Diagnostica is recalling Anti-Ro (SS-A) ELISA kits due to incorrect labeling. The label incorrectly states 'Manufactured by DiaSorin' instead of 'Distributed by DiaSorin'.

    Product
    is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of autoantibodies specific for Anti-Ro (SS-A) antigen in human serum or plasma. EDTA, lithium heparin, citrated plasma. It is intended to aid in the diagnosis of systemic rheumatic…
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-2920-2018·2018-08-29

    Euro Diagnostica Anti-Cardiolipin ELISA Kits Recalled for Labeling Error

    Euro Diagnostica AB is recalling Anti-Cardiolipin ELISA kits due to incorrect labeling. The kits were incorrectly labeled as 'Manufactured by DiaSorin' instead of 'Distributed by DiaSorin.'

    Product
    is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of IgG and IgM autoantibodies specific for the phospholipid cardiolipin in human serum and EDTA, lithium heparin or citrated plasma. It is intended to assess of anti-cardiolipin IgG…
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-2922-2018·2018-08-29

    Euro Diagnostica Scl-70 ELISA Kits Recalled for Labeling Error

    Euro Diagnostica AB is recalling four Scl-70 ELISA kits due to incorrect distribution labeling. The kits were manufactured by DiaSorin but incorrectly labeled as manufactured by them.

    Product
    is a qualitative indirect enzyme immunoassay enzyme-linked immunosorbent assay (ELISA) for the detection, in human serum or plasma, of antibodies specific for the Scl-70 antigen. The test is intended to as an aid to the diagnosis of scleroderma and is not definitive in…
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2824-2018·2018-08-22

    Sorin Platinium CRT-D Recall Due to Pacing and Sensing Loss

    Sorin CRM SAS is recalling 16 Platinium CRT-D devices because a hardware defect may cause loss of pacing and sensing, preventing the device from delivering necessary defibrillation.

    Product
    Sorin Platinium CRT-D 1711 DF-1, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator
    Category
    Medical Device
    Distribution
    9 states
  • SevereFDA (Devices)·Z-2811-2018·2018-08-22

    ICU Medical Recalls Smallbore I.V. Administration Sets Due to Leak Risk

    ICU Medical is expanding a recall of specific smallbore I.V. administration sets because they may leak or separate at the manifold connection.

    Product
    61 cm (24") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, MicroClave Clear, 1.2 Micron Filter, 3 Gang 4-Way NanoClave Stopcock (Glow, Blue, Red Rings), Rotating Luer, 2 Ext.
    Category
    Medical Device
    Distribution
    7 states
  • SevereFDA (Devices)·Z-2589-2018·2018-08-22

    Spacelabs Arkon Anesthesia Delivery System Recalled for Ventilation Failure Risk

    Spacelabs Healthcare is recalling 328 Arkon Anesthesia Delivery Systems because they may stop providing mechanical ventilation while in use or idle.

    Product
    Arkon Anesthesia Delivery System with Arkon Software Version 2.70, Display Unit Assembly 650-1769-00 installed, and Model #: 99999. This system includes a ventilator. The Spacelabs Arkon Anesthesia Workstation is intended for use in the hospital environment and operating…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2791-2018·2018-08-22

    Cook Inc. Recalls VentriClear Ventricular Drainage Catheter Sets Due to Endotoxin Failure

    Cook Inc. is recalling 250 units of the VentriClear Ventricular Drainage Catheter Set because the product failed endotoxin testing. The recall involves one distributor in Indiana, and the product was not distributed to end users.

    Product
    VentriClear Ventricular Drainage Catheter Set, Cat. No. N-VVDC-01-ABRM Product Usage: The VentriClear Ventricular Drainage Catheter Set has been designed for obtaining access to a ventricular cavity of the brain for short-term use to externally drain fluid for the purpose of…
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2825-2018·2018-08-22

    Sorin Platinium CRT-D Recall Due to Loss of Pacing and Sensing

    Sorin CRM SAS is recalling 10 Platinium CRT-D devices because a hardware issue may cause loss of pacing and sensing, preventing the device from detecting arrhythmias.

    Product
    Sorin Platinium CRT-D 1741 DF-4, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator
    Category
    Medical Device
    Distribution
    9 states
  • SevereFDA (Devices)·Z-2799-2018·2018-08-22

    ICU Medical Recalls I.V. Administration Sets Due to Leak Risk

    ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or component separation.

    Product
    30 cm (12") PUR Bifuse Ext Set w/3-Port NanoClave Manifold, Check Valve, 2 NanoClave, Rotating Luer a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system.
    Category
    Medical Device
    Distribution
    7 states
  • SevereFDA (Devices)·Z-2793-2018·2018-08-22

    NxStage Express Fluid Warmer Recalled for Electrical Fire Risk

    NxStage Medical is recalling Express Fluid Warmers due to a potential risk of electrical fire if fluid leaks into the power receptacle.

    Product
    NxStage Express Fluid Warmer (FW-300, FW-300-A, FW-300-WW, FW-301, FW-301-A) Product Usage: The NxStage Express Fluid Warmer is an accessory to the NxStage System One used to warm therapy fluids prior to administration.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2813-2018·2018-08-22

    ICU Medical Recalls I.V. Administration Sets Due to Leak Risk

    ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or component separation.

    Product
    10" Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, Clamp, Rotating Luer
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2816-2018·2018-08-22

    ICU Medical Recalls I.V. Administration Sets Due to Leak Risk

    ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or separation between the luer and manifold.

    Product
    6" Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, Clamp, Rotating Luer.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2832-2018·2018-08-22

    Beekley TomoSPOT Mammography Skin Markers Recalled for Imaging Artifacts

    Beekley Corporation is recalling TomoSPOT skin markers used in mammography because they may create imaging artifacts that mimic calcifications on patient mammograms.

    Product
    TomoSPOT REF 782, 782S, 783, 783S, 784, 784S, 785 & 785S Adhere to skin for marking and identifying moles in mammography.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2804-2018·2018-08-22

    ICU Medical Recalls I.V. Administration Sets Due to Leak Risk

    ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or separation between the female luer and the manifold.

    Product
    28 cm (11") PUR Bifuse Ext Set w/6-Port NanoClave Manifold, Check Valve, 2 NanoClave, Rotating Luer.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2787-2018·2018-08-22

    Wondfo Recalls TCube Oral Fluid Drug Test Cubes Due to Choking Hazard

    Guangzhou Wondfo Biotech is recalling 16,000 TCube One Step Multi-Drug Oral Fluid Test Cubes because the saliva collection device may fail, causing the foam tip to dislodge and create a choking hazard.

    Product
    TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO,COC20,METSO, OPl40,OXY20,THC2S) Product Usage: T-Cube¿ One Step Multi-Drug Oral Fluid Test Cube is a rapid oral fluid screening test. The test is a lateral flow, one-step immunoassay for the qualitative detection of…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2830-2018·2018-08-22

    Beekley O-SPOT REF 791 Mammography Markers Recalled for Imaging Artifacts

    Beekley Corporation is recalling O-SPOT REF 791 and 791S skin markers because they may create imaging artifacts that mimic calcifications on mammograms.

    Product
    O-SPOT REF 791, 791S Adhere to skin for marking and identifying moles in mammography.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2814-2018·2018-08-22

    ICU Medical Recalls I.V. Administration Sets with NanoClave Manifold

    ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or separation between the female luer and the manifold.

    Product
    11" Smallbore Ext Set w/NanoClave, 6-Port NanoClave Manifold, Check Valve, Clamp, Rotating Luer.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2796-2018·2018-08-22

    Hamilton-C3 Ventilator Recalled Due to Control Board Component Defect

    Hamilton Medical AG is recalling two Hamilton-C3 ventilators because an out-of-specification control board component may cause the device to shut down and trigger alarms.

    Product
    Hamilton-C3 Ventilator Unit Product Usage: The HAMILTON-C3 ventilator is intended to provide positive pressure ventilator support to adults, pediatrics, infants and neonates depending on its configuration. The device is used in the intensive care ward, intermediate care…
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-2806-2018·2018-08-22

    ICU Medical Recalls I.V. Administration Sets Due to Leak Risk

    ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or separation between the female luer and the manifold.

    Product
    Kit w/3 Ext Sets, 3 Drop-In MicroClave Clear
    Category
    Medical Device
    Distribution
    7 states