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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18601–18625 of 40248

  • HighFDA (Devices)·Z-0819-2020·2020-01-29

    GE Healthcare Recalls Centricity Universal Viewer 6.0 for Measurement Errors

    GE Healthcare is recalling Centricity Universal Viewer 6.0 because incorrect measurements in DICOM files may lead to potential misdiagnosis.

    Product
    Centricity Universal Viewer 6.0, a device that displays medical images and data from various imaging sources, and from other healthcare information sources.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0822-2020·2020-01-29

    Isopure Sodium Bicarbonate Mixing System Recalled for Magnet Encapsulation Defect

    Isopure Corp is recalling one IsoMix PRO system due to a potential magnet encapsulation defect that could cause corrosion and iron exposure.

    Product
    Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) with a Finish Thompson Centrifugal Pump Model #110192-3
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-0839-2020·2020-01-29

    Soredex DIGORA Optime X-Ray Imager PSU Insulation Recall

    Palodex Group Oy is recalling 297 Soredex DIGORA Optime X-ray imagers because plastic insulation in the power supply may degrade, causing short circuits, heating, and smoke.

    Product
    Soredex DIGORA Optime SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0840-2020·2020-01-29

    Gendex X-Ray Imager Recall Due to Power Supply Insulation Degradation

    Palodex Group Oy is recalling Gendex GXPS-500 X-ray imagers because plastic insulation in the power supply may degrade, causing short circuits, heating, and smoke.

    Product
    Gendex GXPS-500 SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0836-2020·2020-01-29

    Paltop Dental Implant Recall Due to Incorrect Cover Screw Packaging

    Paltop Advanced Dental Solutions is recalling 67 dental implants because some were packaged with the wrong cover screw, preventing proper fit.

    Product
    Paltop Dynamic Dental Implant Dia 3.25mm L 13.0 mm, Catalog Number 21-70020
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-0826-2020·2020-01-29

    Acclarent Recalls TruDi NAV Suction Instruments Due to Calibration Issues

    Acclarent, Inc. is recalling three lots of TruDi NAV Suction Instruments because calibration issues cause incorrect tip orientation displays.

    Product
    TruDi NAV Suction, TDNS090Z, 90 Degree Tip Angle, (01) 10705031245891
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0828-2020·2020-01-29

    Medicrea Pass LP Blunt K-wire Recalled for Incompatibility with Screws

    Medicrea International is recalling 190 units of Pass LP Blunt K-wires because they may not fit into Conical Cannulated Screws.

    Product
    Medicrea Pass LP Blunt K-wire 01.6mm x 500mm-Nitinol Product reference: A06010140
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0844-2020·2020-01-29

    Arrow Arterial Catherization Kit Recalled for Incorrect MR Labeling

    Arrow International is recalling 80 kits due to a lidstock label error that displays an MR Conditional symbol instead of MR Unsafe.

    Product
    Arrow Arterial Catherization Kit-20 Ga. x 4.45 cm Radiopaque Polyurethane over 22 Ga. TW Introducer Needle with Integral .018" (0.46 mm) dia. Spring-Wire Guide Product Code: ASK-04020-PMC The Arrow¿ Arterial Catheterization device permits access to the peripheral arterial…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0824-2020·2020-01-29

    Acclarent Recalls TruDi NAV Suction Instruments Due to Calibration Issues

    Acclarent, Inc. is recalling TruDi NAV Suction Instruments because calibration issues cause incorrect tip orientation displays.

    Product
    TruDi NAV Suction, TDNS000Z, 0 Degree Tip Angle, (01)10705031245877
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0825-2020·2020-01-29

    Acclarent Recalls TruDi NAV Suction Instruments Due to Calibration Issues

    Acclarent, Inc. is recalling specific lots of TruDi NAV Suction Instruments because calibration issues cause incorrect tip orientation displays.

    Product
    TruDi NAV Suction, TDNS070Z, 70 Degree Tip Angle (01) 10705031245884
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0831-2020·2020-01-29

    Siemens ADVIA Centaur Folate Test Kits Recalled for Potential Cross-Reactivity

    Siemens is recalling 3,627 ADVIA Centaur Folate test kits because homocysteine assays may cause elevated folate results.

    Product
    Siemens ADVIA Centaur Folate (500 Test Kit Reference)- for IVD of folate in serum or red blood cell SMN: 10331250
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0827-2020·2020-01-29

    Medicrea Pass LP Trocar K-wire Recalled for Fit Issues

    Medicrea International is recalling 30 units of Pass LP Trocar K-wires because they may not fit into conical cannulated screws.

    Product
    Medicrea Pass LP Trocar K-wire 01.6mm x 500mm-Nitinol Product reference : A06010130
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0829-2020·2020-01-29

    Siemens ADVIA Centaur Folate 100 Test Kits Recalled for Elevated Results

    Siemens is recalling 12,796 ADVIA Centaur Folate 100 test kits because homocysteine assays may cause elevated folate results.

    Product
    Siemens ADVIA Centaur Folate 100 test kit-for IVD of folate in serum or red blood cells SMN:10310308
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0818-2020·2020-01-29

    Greiner Bio-One Recalls Damaged Vacuette Blood Collection Tubes

    Greiner Bio-One is recalling 1,002,000 Vacuette tubes that may have cap sealing damage, potentially causing vacuum loss and improper blood volume collection.

    Product
    VACUETTE TUBE, 3.5mL CAL Serum Sep Clot Activator, REF 454067P - Product Usage: VACUETTE Tubes, Holders, and Needles are use together as a system for the collection of venous blood. VACUETTE tubes are used to collect, transport, and process blood for testing serum, plasma, or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0820-2020·2020-01-29

    Koios DS Breast Software Recalled for Missing Quality Documentation

    Koios Medical is recalling 10 units of Koios DS Breast software due to insufficient documentation of required quality procedures.

    Product
    Koios DS Breast <series 1.0>. The device is a software application which assists skilled physicians in analyzing breast ultrasound images.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0800-2020·2020-01-22

    Edwards Lifesciences Recalls QuickDraw Venous Cannulas Due to Connector Separation Risk

    Edwards Lifesciences is recalling QuickDraw Venous Cannulas because the device may separate from its connector if used for more than six hours, potentially causing significant blood loss.

    Product
    QuickDraw Venous Cannula, REF: QD22, UDI: 00690103182699; and REF: QD25, UDI: 00690103182705
    Category
    Medical Device
    Distribution
    41 states
  • SevereFDA (Devices)·Z-0799-2020·2020-01-22

    Trilliant Gridlock Ankle Screw Driver Bit Recalled for Specification Defect

    Trilliant Surgical is recalling 20 Gridlock Ankle Screw Driver Bits because they are out of specification and may fail to retain screws during implant procedures.

    Product
    Gridlock Ankle Screw Driver Bit REF 320-35-003 - Product Usage: A screwdriver facilitates implant insertion and removal.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0817-2020·2020-01-22

    Physio-Control Recalls LIFEPAK 15 Monitor/Defibrillator Service Kits

    Physio-Control is recalling 705 LIFEPAK 15 Monitor/Defibrillator service kits because oxidation may prevent the device from delivering a shock.

    Product
    LIFEPAK 15 MONITOR/DEFIBRILLATOR service kits
    Category
    Medical Device
    Distribution
    Distributed nationwide