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.

20576–20600 of 50413

  • HighNHTSA·21V299000·2021-04-28

    Suzuki Recalls 2019-2020 UH200 Motorcycles Due to Speedometer Defect

    Suzuki is recalling 2019-2020 UH200 motorcycles because corroded speedometer resistors may cause the speedometer and odometer to stop working, increasing crash risk.

    Product
    SUZUKI — SUZUKI UH200
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1462-2021·2021-04-28

    Biotronik ILIVIA Neo 7 VR-T DF-1 ProMRI Recall for Battery Depletion

    Biotronik is recalling 74 ILIVIA Neo 7 VR-T DF-1 ProMRI implantable cardioverter defibrillators due to a potential for premature battery depletion.

    Product
    BIOTRONIK ILIVIA NEO 7 VR-T DF-1 ProMRI, REF 429531, UDI: 04035479156763 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1451-2021·2021-04-28

    Biotronik ITREVIA 7 Defibrillators Recalled for Premature Battery Depletion

    Biotronik is recalling 499 ITREVIA 7 defibrillators due to a potential for premature battery depletion. The devices are distributed nationwide and worldwide.

    Product
    BIOTRONIK ITREVIA 7, VR-T DF-1, REF 393040, UDI: 04035479129552 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0460-2021·2021-04-28

    Mountain West Mothers' Milk Bank Recalls Pasteurized Donor Human Milk

    Mountain West Mothers' Milk Bank is recalling pasteurized donor human milk bottles due to a foreign object found in a bottle. The affected milk was distributed in Salt Lake County and Utah County, Utah.

    Product
    Mountain West Mothers' Milk Bank - Pasteurized Donor Human Milk, 3 fluid ounce BPA free plastic bottles, embossed with "Donor Human Milk" and graduation marks on the front side Unique identifier label which includes distributing Milk Bank Code (MWMMB), Batch ID, Unique Bottle…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1471-2021·2021-04-28

    Smiths Medical Recalls Medex High Pressure Adaptors and LogiCal Kits

    Smiths Medical ASD Inc. is recalling specific lots of Medex High Pressure Adaptors and LogiCal Kits due to insufficient or incomplete welds.

    Product
    Mark 910 LogiCal, Model Number DPS567201. for blood pressure monitoring and blood sampling.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1454-2021·2021-04-28

    Biotronik Inventa 7 ICDs Recalled for Premature Battery Depletion

    Biotronik is recalling 702 Inventa 7 ICDs due to a potential for premature battery depletion. The devices are distributed nationwide and worldwide.

    Product
    BIOTRONIK INVENTRA 7, HF-T QP DF4 IS4, REF 393012, UDI: 04035479129286 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1455-2021·2021-04-28

    Biotronik ITREVIA 7 Defibrillators Recalled for Premature Battery Depletion

    Biotronik Inc is recalling 658 ITREVIA 7 implantable defibrillators due to a potential for premature battery depletion.

    Product
    BIOTRONIK ITREVIA 7, DR-T QP DF-1, REF 392412, UDI: 04035479128807 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·21119·2021-04-28

    Pentair Recalls StaRite and Mastertemp Pool Heaters Due to Fire Hazard

    Pentair Water Pool and Spa is recalling about 4,700 StaRite and Mastertemp pool heaters because a connection can leak a combustible air-gas mixture, posing a fire hazard.

    Product
    StaRite and Mastertemp pool heaters
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·21V298000·2021-04-28

    2021 BMW 330E Seat Belt Buckle Assembly Bolt Not Properly Secured

    BMW is recalling certain 2021 330E, 330i, M340i, and M3 vehicles due to an undertightened bolt on the front seat belt buckle assembly. The defect may prevent proper occupant restraint, increasing injury risk.

    Product
    BMW — BMW M340I, 330I, 330E, M3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V300000·2021-04-28

    Blue Bird Recalls 2018-2021 School Buses for Power Steering Defect

    Blue Bird is recalling 2018-2021 Vision and All American school buses because an electrical issue may cause a loss of power steering, increasing crash risk.

    Product
    BLUE BIRD — BLUE BIRD ALL AMERICAN SCHOOL BUS, ALL AMERICAN, VISION, VISION SCHOOL BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1480-2021·2021-04-28

    Smiths Medical Recalls Tubing Components Due to Incomplete Welds

    Smiths Medical ASD Inc. is recalling specific lots of tubing components for blood-pressure transducers due to insufficient or incomplete welds.

    Product
    Tubing with male luer lock adapter (Component) a. 76 cm, REF 601280 b. 122 cm, REF 607281. component of extravascular blood-pressure Transducer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1449-2021·2021-04-28

    BIOTRONIK IPERIA 7 ICDs Recalled for Premature Battery Depletion

    BIOTRONIK Inc is recalling 3,832 IPERIA 7 ICDs and CRT-Ds due to a potential for premature battery depletion. The devices are distributed nationwide and worldwide.

    Product
    BIOTRONIK IPERIA 7,VR-T, DX, DF-1, ProMRI, REF 393032, UDI: 04035479129477 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1456-2021·2021-04-28

    Biotronik ILIVIA 7 ICD Recall for Premature Battery Depletion

    Biotronik is recalling 3,497 ILIVIA 7 implantable cardioverter defibrillators due to a potential for premature battery depletion. The recall covers units distributed nationwide and worldwide.

    Product
    BIOTRONIK ILIVIA 7, DR-T DF4 ProMRI, REF 404623, UDI: 04035479142100 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1446-2021·2021-04-28

    Biotronik Iperia 7 Defibrillators Recalled for Premature Battery Depletion

    Biotronik is recalling 1,652 Iperia 7 defibrillators due to a potential for premature battery depletion. The devices are distributed nationwide and worldwide.

    Product
    BIOTRONIK Iperia 7, DR-T, DF-1, ProMRI REF 392409, UDI: 04035479128777 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1441-2021·2021-04-28

    BIOTRONIK Ilestro 7 DR-T ICDs Recalled for Premature Battery Depletion

    BIOTRONIK Inc is recalling Ilestro 7 DR-T implantable cardioverter defibrillators due to a potential for premature battery depletion.

    Product
    BIOTRONIK Ilestro 7 DR-T, DF-1, REF383562, UDI: 04035479125189 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1478-2021·2021-04-28

    Smiths Medical Recalls Medex High Pressure Tubing Due to Weld Defects

    Smiths Medical ASD Inc. is recalling specific lots of Medex high pressure tubing and components due to insufficient or incomplete welds.

    Product
    HIGH PRESSURE TUBING, 72IN, Model Number MX152114 (Component). Stopcocks and manifolds are used to control the direction of IV fluid flow.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1470-2021·2021-04-28

    Smiths Medical Recalls LogiCal Monitoring Sets Due to Incomplete Welds

    Smiths Medical ASD Inc. is recalling specific lots of LogiCal Monitoring Sets and related components due to insufficient or incomplete welds.

    Product
    LogiCal Monitoring Set, Model Number DPS564898. for blood pressure monitoring and blood sampling.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1458-2021·2021-04-28

    Biotronik ILIVIA 7 Defibrillators Recalled for Premature Battery Depletion

    Biotronik is recalling 779 ILIVIA 7 defibrillators due to a potential for premature battery depletion. The devices are distributed nationwide and worldwide.

    Product
    BIOTRONIK ILIVIA 7, VR-T DF4 ProMRI, REF 404626, UDI: 04035479142131 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1461-2021·2021-04-28

    Biotronik ILIVIA 7 Defibrillators Recalled for Premature Battery Depletion

    Biotronik Inc is recalling 1,547 ILIVIA 7 defibrillators due to a potential for premature battery depletion. The devices are distributed nationwide and worldwide.

    Product
    BIOTRONIK ILIVIA 7, DR-T DF-1 PROMRI, REF 404622, UDI: 04035479142094 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1472-2021·2021-04-28

    Smiths Medical Recalls Left Heart Kits Due to Incomplete Welds

    Smiths Medical ASD Inc. is recalling specific lots of Left Heart Kits and related components due to insufficient or incomplete welds.

    Product
    Left Heart Kit, Model Number M20268. for blood pressure monitoring.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1457-2021·2021-04-28

    Biotronik ILIVIA 7 ICDs Recalled for Premature Battery Depletion

    Biotronik is recalling 914 ILIVIA 7 ICDs due to a potential for premature battery depletion. The devices are distributed nationwide and worldwide.

    Product
    BIOTRONIK ILIVIA 7, VR-T DF-1 ProMRI, REF 404625, UDI: 04035479142124 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·21V302000·2021-04-28

    2021 Hyundai Elantra seat back recliner frame welding defect

    Hyundai is recalling certain 2021 Elantra vehicles because the driver and front passenger seat back recliners may have been improperly welded and could separate during a crash, increasing injury risk.

    Product
    HYUNDAI — HYUNDAI ELANTRA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·21118·2021-04-28

    UST Recalls LifeSeasons Iron Supplement Due to Child-Resistant Packaging Failure

    UST Mfg. LLC. is recalling LifeSeasons Blood Nourish-R iron supplements because the bottles do not meet child-resistant packaging requirements, posing a poisoning risk to young children.

    Product
    LifeSeasons Blood Nourish-R Iron Supplement
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1450-2021·2021-04-28

    Biotronik ITREVIA 7 Defibrillators Recalled for Premature Battery Depletion

    Biotronik is recalling 386 ITREVIA 7 implantable defibrillators due to a potential for premature battery depletion.

    Product
    BIOTRONIK ITREVIA 7, VR-T DX DF-1, REF 393037, UDI: 04035479129521 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1464-2021·2021-04-28

    Biotronik ILIVIA NEO 7 DR-T DF-1 ProMRI Defibrillators Recalled for Battery Depletion

    Biotronik is recalling 98 ILIVIA NEO 7 DR-T DF-1 ProMRI defibrillators due to a potential for premature battery depletion.

    Product
    BIOTRONIK ILIVIA NEO 7 DR-T DF-1 ProMRI, REF 429529, UDI: 04035479156749 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide