The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

22776–22800 of 50430

  • HighFDA (Devices)·Z-2473-2020·2020-07-08

    Elekta Unity Radiation Therapy System Recalled for Heating Issues

    Elekta, Inc. is recalling 21 Unity Image-Guided Radiation Therapy Systems due to reports of excessive heating in the MRL Gradient Connection Module.

    Product
    Elekta Unity, Image-Guided Radiation Therapy System
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2444-2020·2020-07-08

    LivaNova Recalls Sterile Disposable Connectors Due to Barrier Breach

    LivaNova USA Inc. is recalling specific lots of Sterile Disposable Connectors because internal tests identified potential breaches in the sterile barrier.

    Product
    Sterile Disposable Connectors ASY 3/16 X 3/16 STR CONNW/LL24. REF/ GTIN for Insert Label:050432000 / 00803622123184
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2472-2020·2020-07-08

    United Imaging uCT 530 CT System Recalled for Scanning Interruptions

    Shanghai United Imaging Healthcare is recalling four uCT 530 Computed Tomography X-Ray Systems in Texas due to software issues that may cause scanning interruptions or image artifacts.

    Product
    uCT 530 Computed Tomography X-Ray System
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2454-2020·2020-07-08

    LivaNova Recalls Sterile Disposable Connectors Due to Barrier Breach

    LivaNova USA Inc. is recalling 744 units of sterile disposable connectors because internal tests found potential breaches in the sterile barrier.

    Product
    Sterile Disposable Connectors ASY Y CONN 1/4 X 1/4 X 1/4 24 REF/ GTIN for Insert Label:050524000/ 00803622123306
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2467-2020·2020-07-08

    Radiometer ABL80-FLEX Box Label Recall for Barcode Misinterpretation Risk

    Radiometer Medical ApS is recalling ABL80-FLEX box labels because barcode misinterpretation on analyzers may cause patient mix-ups or delayed treatment.

    Product
    ABL80-FLEX-393-839 Box Label, REF 393-839, IVD, CE, UDI: 05700693938394 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2446-2020·2020-07-08

    LivaNova Recalls Sterile Disposable Connectors Due to Barrier Breach

    LivaNova USA Inc. is recalling specific lots of Sterile Disposable Connectors because internal tests found potential breaches in the sterile barrier.

    Product
    Sterile Disposable Connectors ASY STR CONN 3/16 STRLE 24. REF/ GTIN for Insert Label:050503000/ 00803622123214
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2475-2020·2020-07-08

    Mueller Hybrid Wraparound Knee Support Recalled for Latex Mislabeling

    Mueller Sports Medicine is recalling Hybrid Wraparound Knee Supports because they contain natural rubber despite being labeled as latex-free.

    Product
    Mueller Sports Medicine Hybrid Wraparound Knee Support, Qty: 1 unit per box
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2441-2020·2020-07-08

    Mediana Attendant Vital Signs Monitor Recalled for Temperature Measurement Failures

    Mediana Co., Ltd. is recalling 180 Attendant Vital Signs Monitors because failures were found in the temperature measurement function while in predict mode.

    Product
    DIRECT SUPPLY Attendant VITAL SIGNS MONITOR, REF AVSM2 - Product Usage: It is vital sign monitor to monitor noninvasive blood pressure (NIBP), functional arterial oxygen saturation (SpO2), pulse rate (PR), temperature (Temp) for adult, pediatric and neonatal patients in all…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2464-2020·2020-07-08

    LivaNova Recalls Vein Irrigation Cannulas Due to Sterile Barrier Breach

    LivaNova is recalling 325 Vein Irrigation Cannulas because internal tests found potential breaches in the sterile barrier, which could compromise sterility.

    Product
    Vein Irrigation Cannula with blunt tip. ASY VIC, STERILE 25/CS REF/ GTIN for Insert Label: VIC/ 00803622133107
    Category
    Medical Device
    Distribution
    44 states
  • HighNHTSA·20V398000·2020-07-07

    Keystone Recalls Fifth-Wheel Trailers Due to Antenna Separation Risk

    Keystone is recalling 2019-2020 fifth-wheel trailers because the television antenna may detach during transit, creating a road hazard.

    Product
    KEYSTONE — KEYSTONE RAPTOR, COUGAR, CARBON, FUZION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20E046000·2020-07-07

    Harbor Freight Recalls Pittsburg Automotive 3 Ton Heavy Duty Steel Jack Stands

    Harbor Freight is recalling 118,000 Pittsburg Automotive 3 Ton Heavy Duty Steel Jack Stands because the base seam weld may fail under load, causing the stand to drop suddenly.

    Product
    EQUIPMENT:MECHANICAL:INTEGRATED JACK/LEVELER/STABILIZER recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·20V396000·2020-07-07

    Chrysler and Dodge Vehicles Recalled for Steering Wheel Emblem Hazard

    Chrysler is recalling specific Town and Country, Grand Caravan, and Nitro models because a loose steering wheel emblem could become a projectile during air bag deployment.

    Product
    CHRYSLER — CHRYSLER, DODGE TOWN AND COUNTRY, NITRO, GRAND CARAVAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·20757·2020-07-02

    Polaris Recalls Phoenix 200 ATVs Due to Throttle Crash Hazard

    Polaris is recalling 2018-2020 Phoenix 200 ATVs because a damaged throttle lever stop can cause a crash. No injuries have been reported.

    Product
    Model Year 2018-2020 Polaris Phoenix 200 ATVs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·20V390000·2020-07-02

    2017-2021 Freightliner Cascadia brake modulator valve corrosion recall

    Certain 2017-2021 Freightliner Cascadia tractor trailers are recalled due to chemical corrosion in the brake modulator valve, which can slow brake release and cause brakes to pull to one side during automatic braking, increasing crash risk.

    Product
    FREIGHTLINER — FREIGHTLINER CASCADIA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V389000·2020-07-02

    Kia Recalls 2015-2016 Soul EV for Parking Mechanism Software Defect

    Kia is recalling 2015-2016 Soul EVs because the parking mechanism may be damaged if the driver shifts to Park before the vehicle stops, potentially causing unintended movement.

    Product
    KIA — KIA SOUL EV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V385000·2020-07-02

    Jayco Recalls 2017 North Point Fifth Wheels for Suspension Defect

    Jayco is recalling 2017 North Point fifth wheel trailers because leaf springs may fail to support loads, risking tire damage and loss of control.

    Product
    JAYCO FIFTH WHEEL — JAYCO FIFTH WHEEL NORTH POINT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·20758·2020-07-02

    Polaris Recalls Ranger and General Utility Vehicles Due to Crash Hazard

    Polaris is recalling approximately 26,730 Ranger and General utility vehicles because a software defect may cause sudden acceleration after a restart, posing a crash risk.

    Product
    Model Year 2019 - 2020 Ranger XP 1000 & Model Year 2020 General XP 1000 Utility Vehicles (UTVs)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2406-2020·2020-07-01

    Mevion Proton Radiation Treatment System Recalled for Software Error

    Mevion Medical Systems is recalling eight MEVION S250i and S250 Proton Radiation Treatment Systems because a software error can cause couch correction moves to be partially lost.

    Product
    MEVION S250i, MEVION S250; Proton Radiation Treatment System
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-2404-2020·2020-07-01

    Siemens Atellica IM1300 Analyzer Recall for Insufficient Sample Detection Failure

    Siemens is recalling 927 Atellica Solution IM1300 Analyzers because they may fail to detect insufficient samples when using specific sample cups.

    Product
    Atellica Solution IM1300 Analyzer, Siemens Material Number 11066001, UDI # 00630414007960
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2429-2020·2020-07-01

    Suntech Oscar 2 Blood Pressure Monitor Recall for Display Error

    Suntech Medical is recalling Oscar 2 blood pressure monitors because the display may show an incorrect decimal point for three-digit readings in mmHg.

    Product
    Oscar 2, Model 250 System
    Category
    Medical Device
    Distribution
    Distributed nationwide