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.

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

21551–21575 of 40299

  • HighFDA (Devices)·Z-0673-2019·2019-01-02

    Tosoh Bioscience Recalls ST AIA-PACK FT3 In Vitro Diagnostic Reagents

    Tosoh Bioscience Inc is voluntarily recalling ST AIA-PACK FT3 reagents used for in vitro diagnostic testing of Free Triiodothyronine. The recall covers 24,083 units distributed nationwide.

    Product
    ST AIA-PACK FT3 (FT3: Free Triiodothyronine) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of Free Triiodothyronine (FT3) in human serum or heparinized plasma on specific Tosoh AIA System analyzers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0662-2019·2019-01-02

    ICU Medical Recalls Iced Thermoset Closed-Loop Injectate Delivery Systems

    ICU Medical is recalling 1,760 units of Iced Thermoset Closed-Loop Injectate Delivery Systems due to a defect in the thermoset check valve that may cause leakage.

    Product
    Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 unit per Cavity #6x12x2.6 Cav/10 pieces per case R1-6090
    Category
    Medical Device
    Distribution
    31 states
  • HighFDA (Devices)·Z-0679-2019·2019-01-02

    RayStation Software Versions Recalled for Dose Tracking Coordinate Errors

    RaySearch Laboratories is recalling specific RayStation software versions because isocenter shifts in dose tracking are incorrectly interpreted.

    Product
    RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayStation 7 and RayStation 8A
    Category
    Medical Device
    Distribution
    30 states
  • HighFDA (Devices)·Z-0680-2019·2019-01-02

    Baxter Recalls GEM Coupler Forceps Due to Potential Rust

    Baxter Healthcare is recalling 123 GEM Coupler Forceps units because of potential rust on the devices. The recall covers nationwide and international distribution.

    Product
    GEM Coupler Forceps, GEM4183C, packaged individually.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0667-2019·2019-01-02

    Abbott Alinity i Estradiol Reagent Kit Recalled for Manufacturing Defect

    Abbott is recalling 79 units of Alinity i Estradiol Reagent Kits due to a manufacturing issue that may cause bottle neck damage and instrument failure.

    Product
    Alinity i Estradiol Reagent Kit, List Number 07P5020
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0660-2019·2019-01-02

    Randox SP CAL (LIQ) Calibrator Recall for Value Sheet Corrections

    Randox Laboratories is recalling SP CAL (LIQ) calibrators because value sheets were modified to improve alignment for specific assays.

    Product
    SP CAL (LIQ), REF IT2692 This product is intended for in vitro diagnostic use with Randox Alpha-1-Antitrypsin, Alpha-1-Acid Glycoprotein, IgA, IgG and IgM assays that require sample predilution.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0670-2019·2019-01-02

    In2bones Recalls NeoSpan Compression Staple Kits Due to Incorrect Drill Bit Size

    In2bones USA, LLC is recalling NeoSpan SuperElastic Compression Staple kits because they contain a 3mm drill bit instead of the required 2mm bit.

    Product
    NeoSpan SuperElastic Compression Staple w/Instruments, Size 10x10x10, Part Number T50 SN010
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-0669-2019·2019-01-02

    Abbott Alinity i 25-OH Vitamin D Reagent Kit Recall for Manufacturing Defect

    Abbott is recalling specific lots of Alinity i 25-OH Vitamin D Reagent Kits due to a manufacturing issue that may damage bottle necks and cause instrument failure.

    Product
    Alinity i 25-OH Vitamin D Reagent Kit, List Number 08P4532
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0685-2019·2019-01-02

    Hologic I-View Contrast Enhanced Digital Mammography System Recall

    Hologic is recalling 337 I-View Contrast Enhanced Digital Mammography systems due to a calibration issue that prevents visualization of contrast uptake.

    Product
    I-View¿ Contrast Enhanced Digital Mammography, ASY-08109
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0676-2019·2019-01-02

    Tosoh Bioscience Recalls ST AIA-PACK ACTH In Vitro Diagnostic Reagents

    Tosoh Bioscience Inc is voluntarily recalling 1,085 units of ST AIA-PACK ACTH in vitro diagnostic reagents distributed nationwide in the US.

    Product
    ST AIA-PACK ACTH (ACTH: Adrenocorticotropic Hormone) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of Adrenocorticotropic hormone (ACTH) in human EDT A plasma. Measurements of ACTH are used in the differential diagnosis and treatment of certain…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0671-2019·2019-01-02

    Tosoh AIA-PACK B12 Recalled Due to Potential Fluorescein Interference

    Tosoh Bioscience Inc is recalling AIA-PACK B12 reagents because fluorescein interference may cause inaccurately elevated Vitamin B12 test results.

    Product
    AIA-PACK B12 (Vitamin B12) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of vitamin B12 (B12) in human serum on Tosoh AIA System analyzers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0666-2019·2019-01-02

    Abbott Recalls Alinity i Total Beta-hCG Reagent Kit Due to Manufacturing Defect

    Abbott is recalling 27 units of the Alinity i Total Beta-hCG Reagent Kit because a manufacturing issue may damage bottle necks, causing reagent loading failures on the instrument.

    Product
    Alinity i Total Beta-hCG Reagent Kit, List Number 07P5121
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0664-2019·2019-01-02

    Abbott Alinity i TSH Reagent Kit Recalled for Manufacturing Defect

    Abbott is recalling Alinity i TSH Reagent Kits due to a manufacturing issue that may damage bottle necks, potentially causing reagent loading failures on the instrument.

    Product
    Alinity i TSH Reagent Kit, List Number 07P4830
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0665-2019·2019-01-02

    Abbott Alinity i Free T4 Reagent Kit Recalled for Manufacturing Defect

    Abbott is recalling 294 units of Alinity i Free T4 Reagent Kits due to a manufacturing issue that may cause bottle neck damage and instrument loading failures.

    Product
    Alinity i Free T4 Reagent Kit, List Number 07P7030
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0675-2019·2019-01-02

    Tosoh Bioscience Recalls ST AIA-PACK Homocysteine Diagnostic Reagents

    Tosoh Bioscience is recalling 992 units of ST AIA-PACK Homocysteine reagents used for in vitro diagnostic testing. The voluntary recall covers all lots distributed nationwide.

    Product
    ST AIA-PACK Homocysteine (HCY) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of homocysteine in human serum, heparinized plasma or EDT A plasma on TOSOH AIA System Analyzers. Homocysteine measurements are used in the diagnosis and treatment of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0668-2019·2019-01-02

    Abbott Alinity i Progesterone Reagent Kit Recalled for Manufacturing Defect

    Abbott is recalling 157 units of Alinity i Progesterone Reagent Kits due to a manufacturing issue that can cause bottle neck damage and instrument failure.

    Product
    Alinity i Progesterone Reagent Kit, List Number 08P3620
    Category
    Medical Device
    Distribution
    6 states
  • SevereFDA (Devices)·Z-0497-2019·2018-12-26

    COVIDIEN Recalls Puritan Bennett 980 Ventilators Due to Software Update Issues

    COVIDIEN LLC is recalling 9,593 Puritan Bennett 980 ventilators worldwide due to a software update affecting external USB drive performance and GUI functionality.

    Product
    Puritan Bennett 980 (PB980) ventilator series: Puritan Bennett" 980 Pediatric Adult Ventilator Puritan Bennett" 980 Neonatal Ventilator Puritan Bennett" 980 Universal Ventilator Product Usage: The Puritan Bennett 980 Series Ventilator is designed for use on patient…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0626-2019·2018-12-26

    FDA Recalls Covidien Emprint Percutaneous Antenna Due to Tip Disengagement

    FDA is recalling specific lots of the Covidien Emprint Short Percutaneous Antenna because the ceramic trocar tip may disengage from the needle shaft during use, potentially remaining in the patient.

    Product
    Covidien Emprint Short Percutaneous Antenna with Thermosphere Technology, Material CA15L2 intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of nonresectable liver tumors.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0615-2019·2018-12-26

    Abbott i-STAT CG8+ Cartridges Recalled for Inaccurate Potassium Results

    Abbott Point Of Care Inc. is recalling i-STAT CG8+ Cartridges because they may generate inaccurate potassium results, potentially leading to incorrect clinical decisions.

    Product
    Abbott i-STAT CG8+ Cartridges intended for use in the in vitro quantification of potassium in arterial, venous, or capillary whole blood. List Number/UDI# : 03P88-25 ,(01)10054749000163(17)181028(10)L18059
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0627-2019·2018-12-26

    FDA Recalls Covidien Emprint Percutaneous Ablation Antenna Due to Tip Disengagement

    FDA is recalling the Covidien Emprint Standard Percutaneous Antenna because the ceramic trocar tip may disengage from the needle shaft, potentially remaining in the patient.

    Product
    Covidien Emprint Standard Percutaneous Antenna with Thermosphere Technology, CA20L2 intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of nonresectable liver tumors.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0625-2019·2018-12-26

    FDA Recalls Covidien Emprint Percutaneous Antenna Due to Tip Disengagement

    FDA is recalling specific lots of the Covidien Emprint Long Percutaneous Antenna because the ceramic trocar tip may disengage from the needle shaft, potentially remaining in the patient.

    Product
    Covidien Emprint Long Percutaneous Antenna with Thermosphere Technology, Material CA30L2 intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of nonresectable liver tumors.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0617-2019·2018-12-26

    Siemens Dimension Vista 1500 Recalled for Potential Sample Contamination

    Siemens is recalling Dimension Vista 1500 instruments due to a software issue that may cause sample contamination if tests are manually cancelled during aliquoting.

    Product
    Dimension Vista 1500, Model No. 10444801 an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0652-2019·2018-12-26

    Ortho-Clinical Diagnostics Recalls VITROS 3600 Immunodiagnostic System Software

    Ortho-Clinical Diagnostics is recalling VITROS 3600 Immunodiagnostic System units due to a software anomaly that may incorrectly extend reagent stability time.

    Product
    VITROS¿ 3600 Immunodiagnostic System, Version 3.3.1 & below For use in the in vitro quantitative measurement of a variety of analytes of clinical interest in certain biological fluids (depending on the analyte) such as serum, plasma, urine and cerebrospinal fluid.
    Category
    Medical Device
    Distribution
    Distributed nationwide