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

Agency

Category

Minimum severity

Clear filters

16426–16450 of 27471

  • HighFDA (Devices)·Z-0661-2019·2019-01-02

    ICU Medical Recalls Thermoset Room Temperature Injectate Delivery Systems

    ICU Medical is recalling 27,250 Thermoset Room Temperature Closed Loop Injectate Delivery Systems due to a defect in the thermoset check valve component that may cause leakage.

    Product
    Thermoset Room Temperature Closed Loop Injectate Delivery System. 1 unit per Cavity #3 Cavity Deep/20 pieces per case R1-6090
    Category
    Medical Device
    Distribution
    31 states
  • HighFDA (Devices)·Z-0682-2019·2019-01-02

    Radiometer ABL800 Analyzer Recalled for Potential Patient Data Mismatch

    Radiometer America Inc is recalling 2,131 ABL800 analyzers because software may cause a mismatch between patient demographics and test results.

    Product
    ABL800 analyzer, model numbers 393-800 and 393-801.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0686-2019·2019-01-02

    Elekta Recalls MOSAIQ Oncology Software Due to Isocenter Copying Error

    Elekta is recalling MOSAIQ Oncology Information System Version 2.64 because copied treatment fields may retain incorrect isocenter settings for imaging.

    Product
    MOSAIQ Oncology Information System Version 2.64. MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0672-2019·2019-01-02

    Tosoh Bioscience Recalls AIA-PACK Folate In Vitro Diagnostic Reagents

    Tosoh Bioscience Inc is voluntarily recalling AIA-PACK Folate reagents used for in vitro diagnostic testing due to a Class II safety concern.

    Product
    AIA-PACK Folate (FOL) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of folate in human serum on Tosoh AIA System analyzers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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
  • 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
  • HighFDA (Devices)·Z-0639-2019·2018-12-26

    bioMerieux Recalls VITEK 2 Systems Software Version 9.01 Update Kit

    bioMerieux is recalling VITEK 2 Systems Software Version 9.01 Update Kits because they may display incorrect organism identification and antimicrobial susceptibility testing results.

    Product
    VITEK¿ 2 Systems Software Version 9.01 Update Kit.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0645-2019·2018-12-26

    Deerfield Imaging Recalls IMRIS T2X Tables Due to Roll Position Drift

    Deerfield Imaging is recalling 15 IMRIS T2X tables because they may drift in the roll position while in use.

    Product
    IMRIS T2X table, Part Numbers: (a)108000-000, (b)108000-600, (c)109682-000, (d) 109682-600, (e) 110470-600 - Product Usage: The ORT200 and ORT300 are intended for use during diagnostic examinations, radiologic procedures, or surgical procedures to support and position a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0648-2019·2018-12-26

    Deerfield Imaging Recalls IMRIS ORT 300 Operating Room Tables

    Deerfield Imaging is recalling 14 IMRIS ORT 300 operating room tables because they may drift in the roll position while in use.

    Product
    IMRIS ORT 300, Removable Operating Room Table, Part Numbers: (a) 114093-000, (b) 114093-006 - Product Usage: The ORT200 and ORT300 are intended for use during diagnostic examinations, radiologic procedures, or surgical procedures to support and position a patient. The tables…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0657-2019·2018-12-26

    Howmedica Recalls Reliance LITe Nerve Hooks Due to Shape Defects

    Howmedica Osteonics Corp. is recalling 39 units of Reliance LITe Nerve Hooks because the probes have incorrect shapes, including flat surfaces and sharp edges.

    Product
    Reliance LITe Nerve Hook Bayoneted, 90, Blunt Tip, REF # 48066103 The blunt probe can be used as a conventional means of achieving nerve retraction. The bend at the proximal tip of the ring the discectomy, as well as during the insertion of an IBD during a conventional TLIF…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0659-2019·2018-12-26

    Konica Minolta Recalls 151 X-Ray Systems Due to Unintentional Movement

    Konica Minolta is recalling 151 Advanced Universal U-Arm 4000 X-ray systems because the U-Arm may move unintentionally.

    Product
    Bucky Stand SU-4000 Input 2017.11.17. SU41711085 Date: 2017-11-17; Board Name; Board Version, Firmware Version Advanced Universal U-Arm 4000 System. The Positioner consists of the following associated subassemblies: Vertical Column, Swivel Arm with variable height, X-ray…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0629-2019·2018-12-26

    Jarvik 2000 Ventricular Assist System External Cables Recalled for Connector Damage

    Jarvik Heart Inc is recalling 274 external cable components for the Jarvik 2000 Ventricular Assist System due to potential damage to male connectors.

    Product
    Jarvik 2000 Ventricular Assist System external components: JHI-212 Y Cable, JHI-202 Lithium-ion Battery Cable, JHI-204 Extensions Cable, JHI-201 Pedestal Cable
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0649-2019·2018-12-26

    Foundation Medicine Recalls 800 FoundationOne CDx Test Reports

    Foundation Medicine is recalling 800 FoundationOne CDx test reports because an incorrect result for a single analyte may have been reported.

    Product
    FoundationOne CDx Test Results
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0619-2019·2018-12-26

    ICU Medical Recalls Sapphire Epidural Sets Due to Occlusion Alarms

    ICU Medical is recalling 31,050 units of Sapphire Epidural Sets due to reports of distal occlusion alarms during use.

    Product
    SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123 Inch, List Number 16373-02 Sapphire Epidural Sets are indicated for the delivery of fluids from a container to a patient's epidural space. Sets are intended for use with Sapphire Infusion Systems.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0647-2019·2018-12-26

    Deerfield Imaging Recalls IMRIS ORT 200 Tables Due to Roll Drift

    Deerfield Imaging is recalling 14 IMRIS ORT 200 operating room tables because they may drift in the roll position while in use.

    Product
    IMRIS ORT 200, Removable Operating Room Table, Part Numbers: (a) 113821-000, (b) 113821-600, (c) 114148-000, (d) 114148-600 - Product Usage: The ORT200 and ORT300 are intended for use during diagnostic examinations, radiologic procedures, or surgical procedures to support and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0646-2019·2018-12-26

    Deerfield Imaging Recalls IMRIS ORT 100 Tables Due to Roll Drift

    Deerfield Imaging is recalling 27 IMRIS ORT 100 tables because they may drift in the roll position during use, posing a risk of patient injury.

    Product
    IMRIS ORT 100 table, Part Numbers: (a) 110470-000, (b) 110470-600 - Product Usage: The ORT200 and ORT300 are intended for use during diagnostic examinations, radiologic procedures, or surgical procedures to support and position a patient. The tables are indicated for imagining…
    Category
    Medical Device
    Distribution
    Distributed nationwide