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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17551–17575 of 40124

  • HighFDA (Devices)·Z-1826-2020·2020-05-06

    Elekta Recalls Leksell Vantage Stereotactic System Instrument Carriers

    Elekta Inc is recalling 25 Leksell Vantage Stereotactic System Instrument Carriers because a faulty locking piece may not meet required locking force standards.

    Product
    Leksell Vantage Stereotactic System. Instrument Carrier, Part of Leksell Vantage Arc (1053958). Neurological stereotaxic Instrument
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1815-2020·2020-05-06

    Welch Allyn S4 Wireless Telemeter Recall for Defibrillation Safety

    Welch Allyn is recalling S4 Wireless Telemeters and patient cables because they may not meet defibrillation withstand safety standards.

    Product
    S4 and patient cable for the S4 Wireless Telemeter with the following device names: CABLE 10 WIRE LF ECG SNAP ENDS AHA GRAY, CABLE 10 WIRE LF ECG SNAP ENDS IEC GRAY, CBL 10WIRE LF LRG ECG SNAP ENDS AHA GRAY, CBL 10WIRE LF LRG ECG SNAP ENDS IEC GRAY. The S4 mobile monitor…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1817-2020·2020-05-06

    Welch Allyn Q-Stress and XScribe Diagnostic Devices Recalled for Safety Standard Deficiency

    Welch Allyn is recalling Q-Stress and XScribe diagnostic devices because they may not meet specific defibrillation withstand safety requirements.

    Product
    Q-Stress/XScribe. Q-Stress or XScribe is a diagnostic device capable of real time ECG display, heart rate measurement, ST analysis and ventricular ectopic beat detection using wired or wireless acquisition modules.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1823-2020·2020-05-06

    U&I Corp. Recalls Velofix SA Cervical Cages Due to Dimensional Defects

    U&I Corp. is recalling 42 Velofix SA cervical cages because screw-hole dimensions may be out of range, posing a risk of screw pullout or instability.

    Product
    Velofix SA cervical cage, REF: TSA161207, TSA161208, TSA161209, TSA161210, TSA161407, TSA161408, TSA161409, TSA161410 - Product Usage:The device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disk disease at one level…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1822-2020·2020-05-06

    Avanos Medical Recalls CORFLO PEG Kits Due to Potential Adapter Occlusion

    Avanos Medical is recalling CORFLO Percutaneous Endoscopic Gastrostomy (PEG) Kits because the tube may become blocked at the adapter, potentially delaying or aborting procedures.

    Product
    CORFLO Percutaneous Endoscopic Gastrostomy (PEG)Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1711-2020·2020-05-06

    GE Healthcare Recalls Lunar iDXA Bone Densitometers Due to Radiation Risk

    GE Healthcare is recalling 123 Lunar iDXA bone densitometers because a control panel issue may cause the start button to stick, potentially leading to accidental radiation exposure.

    Product
    Lunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v17) bone densitometer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1810-2020·2020-05-06

    Welch Allyn Electrocardiographs Recalled for Defibrillation Safety Non-Compliance

    Welch Allyn is recalling 78,521 lead diagnostic electrocardiographs because they may not meet defibrillation withstand requirements.

    Product
    Lead diagnostic electrocardiograph under the following device names: ELI 10, ELI 350, ELI 150c, ELI 250c, ELI 230, ELI 280, ELI 380, R-Scribe and Connex Cardio. Product Usage: A non-invasive prescription device indicated for use to acquire, analyze, display, transmit and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1812-2020·2020-05-06

    Welch Allyn H12+ Holter Recorders Recalled for Defibrillation Safety Non-Compliance

    Welch Allyn is recalling H12+ Holter Recorders and patient cables because they may not meet defibrillation withstand requirements.

    Product
    H12+ and patient cable for the H12+ Holter Recorders with the following device name: PAT CBL 10WIRE LEADFORM AHA SNAP, PAT CBL 10WIRE LEADFORM IEC SNAP, PAT CBL 10WIRE LEADFORM XL AHA SNAP, PAT CBL 10WIRE LEADFORM XL IEC SNAP. The 24-hour H12+ recorder uses a single AA…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1795-2020·2020-05-06

    Becton Dickinson Recalls CareFusion Safe-T-Centesis Catheter Drainage Trays

    Becton Dickinson is recalling 900 units of CareFusion Safe-T-Centesis Catheter Drainage Trays because the 8 Fr catheter was manufactured with a 6.9 Fr needle instead of the correct 8 Fr needle.

    Product
    CareFusion Safe-T-Centesis Catheter Drainage Tray, Sterile, For Single Use Only, Rx only, Catalog Number PIG1280T, UDI Number 01)10885403108402(17) 210930(10)0001304986
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-1833-2020·2020-05-06

    Baxter Prismaflex System Recall for Connector Usage Safety Information

    Baxter Healthcare is issuing a Class II recall for 133 Prismaflex Systems to communicate safety information regarding the proper use of connectors.

    Product
    Prismaflex System, Prismaflex Control Unit
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1830-2020·2020-05-06

    Baxter Prismaflex System Safety Communication on Connector Use

    Baxter issued a safety communication regarding the proper use of connectors with the Prismaflex System and Control Unit.

    Product
    Prismaflex System, Prismaflex Control Unit
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1804-2020·2020-05-06

    Boston Scientific Recalls iLab Polaris Systems Due to Data Archiving Bug

    Boston Scientific is recalling 150 iLab Polaris and Ultrasound systems in Europe because a software bug prevents specific data from being archived without notifying the user.

    Product
    iLab Polaris Multi-Modality Guidance System; iLab Ultrasound Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1820-2020·2020-05-06

    Smiths Medical Recalls Mislabeled Portex Lumbar Puncture Trays

    Smiths Medical ASD Inc. is recalling 100 units of Portex Lumbar Puncture Trays because the inner trays were mislabeled with an incorrect model number.

    Product
    Portex Lumbar Puncture Tray. Anesthesia Conduction Kit. 4826PL-20 - Product Usage: Portex lumbar puncture trays provide all the materials necessary to measure cerebrospinal fluid pressure and/or collect cerebrospinal fluid specimens. Key components include skin prep materials…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1797-2020·2020-05-06

    Siemens Atellica CH 930 Analyzer Recall for Software Defect

    Siemens is recalling Atellica CH 930 Analyzers with specific software versions due to a defect that may cause incorrect test results.

    Product
    Atellica CH 930 Analyzer, Siemens Material Number 11067000 with software version v1.21.0 SP1 or lower
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1800-2020·2020-05-06

    Bio-Rad Autoimmune EIA Anti-Tissue Transglutaminase IgA Test Recalled for Lot Bias

    Bio-Rad Labs is recalling 376 units of the Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA Test, Lot 18200A, due to elevated lot-to-lot bias affecting antibody measurements.

    Product
    Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA Test; Material Number 425-2260; Lot number 18200A - Product Usage: The assay is an aid in the diagnosis of celiac disease (gluten-sensitive enteropathy) and should be used in conjunction with other serological tests and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1805-2020·2020-05-06

    Obalon Balloon System Recalled Due to Touchscreen Calibration Issues

    Obalon Therapeutics is recalling 45 Obalon Balloon Systems because the touchscreen may lose calibration, preventing balloon inflation.

    Product
    Obalon Balloon System with Model 4300 Touch Dispenser Touchscreen; Software version 02.00.00.0076 - Product Usage: The System is intended to be used as an adjunct to a moderate intensity diet and behavior modification program. All balloons must be removed 6 months after the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1829-2020·2020-05-06

    Baxter Prismaflex System Recall for Connector Safety Information

    Baxter is recalling 1,225 Prismaflex Systems to communicate safety information regarding the proper use of connectors.

    Product
    Prismaflex System, Prismaflex Control Unit
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1798-2020·2020-05-06

    Boston Scientific Recalls MoXy Laser Fiber for Breakage Risk

    Boston Scientific is recalling MoXy Laser Fibers to update instructions and reduce the likelihood of metal cap and fiber tip breakage.

    Product
    MoXy Laser Fiber, Material Number 0010-2400 - Product Usage: The fiber can be used for the surgical incision/excision, vaporization, ablation, hemostasis and coagulation of soft tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1807-2020·2020-05-06

    Stryker Neptune E-SEP Blade Electrode Recalled for Expired Product

    Stryker is recalling 40 units of Neptune E-SEP 165mm Blade Electrodes shipped to Canada because they were expired due to a distribution error.

    Product
    Neptune E-SEP 165mm Blade Electrode, Catalog Number 0703-165-001 - Product Usage: The Neptune E-SEP is an Integrated Smoke Evacuation Pencil (pencil) designed for general electrosurgical applications including cutting and coagulation, and for removing smoke generated by…
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1834-2020·2020-05-06

    Ortho VITROS TT4 Reagent Pack Recalled for Calibration Failures

    Ortho Clinical Diagnostics is recalling VITROS TT4 Reagent Packs due to increased unsuccessful calibrations. The recall affects 3,181 units distributed in the US and 23 other countries.

    Product
    VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1746-2020·2020-04-29

    Wilson-Cook Recalls HEMO-10 Hemospray Endoscopic Hemostat Devices

    Wilson-Cook Medical is recalling HEMO-10 Hemospray Endoscopic Hemostat devices because the handle or activation knob may crack or break, potentially causing the carbon dioxide cartridge to exit the handle.

    Product
    HEMO-10 Hemospray Endoscopic Hemostat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1786-2020·2020-04-29

    Degania Recalls Temperature Sensing Foley Catheters Due to Inspection Failures

    Degania Medical Devices is recalling specific lots of temperature sensing Foley catheters because inadequate incoming inspection practices were used on the thermistor sensors.

    Product
    Temperature Sensing 100% Silicone Foley Catheter, Part Number 102202101863DO - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
    Category
    Medical Device
    Distribution
    Distributed nationwide