The Recall Desk

Hazard

Hypoglycemia Risk recalls

25 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
25
Critical
1
Severe
2
Most recent
2026-04-22

Of the 25 hypoglycemia risk recalls we have scored against our rubric, 1 (4%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (8%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all hypoglycemia risk recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–25 of 25

  • HighFDA (Devices)·Z-1809-2026·2026-04-22

    iLet Ace insulin pump lock screens can be bypassed by users

    iLet Ace Pump Kits are being recalled because active status bar icons on the lock and passcode screens allow those screens to be bypassed, permitting unauthorized access.

    Product
    iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1749-2026·2026-04-08

    Paradigm REAL-Time insulin pump delivery varies with pump height

    Medtronic is recalling Paradigm REAL-Time insulin pumps because raising or lowering the pump relative to the infusion site can cause unintended over- or under-delivery of insulin.

    Product
    Paradigm REAL-Time Insulin Pump (MMT-522, MMT-722)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1751-2026·2026-04-08

    MiniMed 530G insulin pump delivery varies with pump height changes

    Medtronic is recalling MiniMed 530G insulin pumps because raising or lowering the pump relative to the infusion site can cause unintended over- or under-delivery of insulin.

    Product
    MiniMed 530G Insulin Pump (MMT-551, MMT-751)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1750-2026·2026-04-08

    Paradigm REAL-Time Revel pump delivery varies with pump height changes

    Medtronic is recalling Paradigm REAL-Time Revel insulin pumps because raising or lowering the pump relative to the infusion site can cause unintended over- or under-delivery of insulin.

    Product
    Paradigm REAL-Time Revel Insulin Pump (MMT-523, MMT-723)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1747-2026·2026-04-08

    MiniMed 620G insulin pump delivery varies with pump height changes

    Medtronic is recalling MiniMed 620G insulin pumps because raising or lowering the pump relative to the infusion site can cause unintended over- or under-delivery of insulin.

    Product
    MiniMed 620G Insulin Pump (MMT-1750)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1752-2026·2026-04-08

    Paradigm REAL-Time Veo pump delivery varies with pump height changes

    Medtronic is recalling Paradigm REAL-Time Veo insulin pumps because raising or lowering the pump relative to the infusion site can cause unintended over- or under-delivery of insulin.

    Product
    Paradigm REAL-Time Veo Insulin Pump (MMT-554, MMT-754)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1743-2026·2026-04-08

    MiniMed 640G insulin pump delivery varies with pump height changes

    Medtronic is recalling MiniMed 640G insulin pumps because raising or lowering the pump relative to the infusion site can cause unintended over- or under-delivery of insulin.

    Product
    MiniMed 640G Insulin Pump (MMT-1711, MMT-1712, MMT-1751, MMT-1752)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1740-2026·2026-04-08

    MiniMed 630G insulin pump delivery varies with pump height changes

    Medtronic is recalling MiniMed 630G insulin pumps because raising or lowering the pump relative to the infusion site can cause unintended over- or under-delivery of insulin.

    Product
    MiniMed 630G Insulin Pump (MMT-1714, MMT-1715, MMT-1754, MMT-1755)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1744-2026·2026-04-08

    MiniMed 700G insulin pump delivery varies with pump height changes

    Medtronic is recalling MiniMed 700G insulin pumps because raising or lowering the pump relative to the infusion site can cause unintended over- or under-delivery of insulin.

    Product
    MiniMed 700G Insulin Pump (MMT-1801, MMT-1805, MMT-1850, MMT-1851)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1742-2026·2026-04-08

    MiniMed 770G insulin pump delivery varies with pump height changes

    Medtronic is recalling MiniMed 770G insulin pumps because raising or lowering the pump relative to the infusion site can cause unintended over- or under-delivery of insulin.

    Product
    MiniMed 770G Insulin Pump (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1745-2026·2026-04-08

    MiniMed 720G insulin pump delivery varies with pump height changes

    Medtronic is recalling MiniMed 720G insulin pumps because raising or lowering the pump relative to the infusion site can cause unintended over- or under-delivery of insulin.

    Product
    MiniMed 720G Insulin Pump (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1748-2026·2026-04-08

    Paradigm insulin pump delivery varies with pump height changes

    Medtronic is recalling Paradigm insulin pumps models MMT-712 and MMT-715 because raising or lowering the pump relative to the infusion site can cause unintended over- or under-delivery of insulin.

    Product
    Paradigm Insulin Pump (MMT-712, MMT-715)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1746-2026·2026-04-08

    MiniMed 740G insulin pump delivery varies with pump height changes

    Medtronic is recalling MiniMed 740G insulin pumps because raising or lowering the pump relative to the infusion site can cause unintended over- or under-delivery of insulin.

    Product
    MiniMed 740G Insulin Pump (MMT-1811, MMT-1812, MMT-1861, MMT-1862)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1741-2026·2026-04-08

    MiniMed 780G insulin pump delivery varies with pump height changes

    Medtronic is recalling MiniMed 780G insulin pumps because raising or lowering the pump relative to the infusion site can cause unintended over- or under-delivery of insulin.

    Product
    MiniMed 780G Insulin Pump (MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT-1896)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1739-2026·2026-04-08

    MiniMed 670G insulin pump delivery varies with pump height changes

    Medtronic is recalling MiniMed 670G insulin pumps because raising or lowering the pump relative to the infusion site can cause unintended over- or under-delivery of insulin.

    Product
    MiniMed 670G Insulin Pump (MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, MMT-1782)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1635-2026·2026-04-01

    Medtronic MiniMed 780G software defects may cause insulin delivery inaccuracies

    Medtronic is recalling MiniMed 780G insulin pumps on software 6.60 and 6.61 because three software defects could result in hypoglycemia or hyperglycemia through inaccurate insulin delivery.

    Product
    MiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 With Software 6.60 and 6.61
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1636-2026·2026-04-01

    Tandem insulin pump Czech guide inverted a key connection instruction

    Tandem Diabetes Care is recalling insulin pumps distributed in the Czech Republic and Slovakia because the Czech user guide contains translation errors, including one that inverts an infusion set instruction.

    Product
    Tandem pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize a motor-driven mechanism to deliver insulin from within a disposable cartridge, through an infusion set, into a patient s subcutaneous tissue. As with current i
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0232-2026·2025-10-29

    Insulin pumps recalled over software defect causing unexpected correction bolus

    Tandem Diabetes Care is recalling 122,958 t:slim X2 and Mobi insulin pumps because a software defect when paired with a Dexcom G7 sensor may trigger an unexpected automatic correction bolus.

    Product
    t:slim X2 insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014070, 1014071, 1014072, 1014073, and User Guide when using Dexcom G7 sensor; Tandem Mobi insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014801, 1014811, 1014813, and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1943-2025·2025-06-25

    Dexcom G6 Glucose Receiver recalled for missed audible alerts

    Dexcom G6 Glucose Receiver units may have defective foam or assembly errors that disable audible alerts for dangerously low or high blood glucose, risking seizures, loss of consciousness, or death.

    Product
    Dexcom G6 Glucose Receiver, SKUs (Part Number): STK-FM-001 (MT27408-1) & STK-FR-001 (MT27408-1)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1262-2025·2025-03-12

    Medtronic MiniMed insulin pump recalled for abnormal delivery during air pressure changes

    Medtronic MiniMed insulin pumps may deliver insulin abnormally during airplane take-off or landing due to air pressure changes, risking severe low or high blood sugar emergencies.

    Product
    MiniMed insulin pump, REF: 700G (MMT-1801, MMT-1805, MMT-1850, MMT-1851)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0395-2017·2016-11-23

    Roche Tina-Quant Hemoglobin A1c Test Recalled for Erroneously High Results

    Roche Diagnostics is recalling Tina-Quant Hemoglobin A1c Gen. 2 tests because they may produce erroneously high results, potentially leading to incorrect diabetes treatment.

    Product
    Tina-Quant Hemoglobin A1c Gen. 2 Hemoglobin A1c test Catalog number 04528123190 / 05401640190
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2883-2016·2016-10-05

    Trividia TRUEread Blood Glucose Test Strips Recalled for Incorrect Low Readings

    Trividia Health is recalling TRUEread Blood Glucose Test Strips because they may provide incorrect low blood glucose levels.

    Product
    TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult and TRUE2go meters. TRUEread Blood Glucose Test Strips are available in vials with 10 ct., 25 ct., 50 ct., and sold as 10 ct. with meters. Quantitatively measure whole blood glucose in a professional
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2881-2016·2016-10-05

    Trividia Health Recalls TRUEread Blood Glucose Test Strips for Inaccurate Readings

    Trividia Health is recalling TRUEread Blood Glucose Test Strips because they may provide incorrect low blood glucose levels.

    Product
    TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult and TRUE2go meters. TRUEread Blood Glucose Test Strips are available in vials with 10 ct., 25 ct., 50 ct., and sold as 10 ct. with meters. Quantitatively measure whole blood glucose in a professional
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1212-2014·2014-03-26

    Abbott Recalls FreeStyle Flash Blood Glucose Meters Due to Inaccurate Results

    Abbott Diabetes Care is recalling FreeStyle Flash Blood Glucose Monitors because they may produce inaccurate low blood glucose readings when used with specific test strips.

    Product
    FreeStyle Flash Blood Glucose Monitors System. Meter made in China; Distributed by TheraSense, Alameda, CA The FreeStyle Flash meter should only be used with FreeStyle Test Strips and FreeStyle Control Solution. Using other brands of test strips and control solutions wi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1211-2014·2014-03-26

    Abbott FreeStyle Blood Glucose Monitors Recalled for Inaccurate Results

    Abbott Diabetes Care is recalling FreeStyle Blood Glucose Monitors because they may produce inaccurate blood glucose readings when used with specific test strips.

    Product
    FreeStyle Blood Glucose Monitors System. For in vitro diagnostic use only. Store at room temperature below 86 degrees F (30 degrees C). Use test strips only within the system operating temperature range as outlined in your Owner's Booklet. Meter made in China; Distributed
    Category
    Medical Device
    Distribution
    Distributed nationwide