The Recall Desk

Hazard

Hypoglycemia recalls

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

What the numbers show

Total
28
Critical
4
Severe
8
Most recent
2026-08-26

Of the 28 hypoglycemia recalls we have scored against our rubric, 4 (14%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 8 (29%) 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 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 28

  • HighFDA (Devices)·Z-2982-2026·2026-08-26

    Medtronic MiniMed 780G Insulin Pumps Recalled for Chemical Damage Risk

    Medtronic is recalling 257 MiniMed 780G insulin pumps distributed in Europe because chemical cleaning agents may have damaged the devices, risking incorrect insulin delivery.

    Product
    MiniMed 780G Insulin Pump, Model: MMT-1885CLW, MMT-1886CLW
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1996-2026·2026-05-06

    iLet Bionic Pancreas Software Versions Recalled for Delayed CGM Readings

    Beta Bionics is recalling iLet Bionic Pancreas units with software versions 1.4.2 and 1.4.3 due to a compatibility issue with Dexcom G7 sensors that can cause delayed glucose readings and loss of automatic insulin adjustments.

    Product
    iLet Bionic Pancreas, REF: BB1001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2016-2025·2025-07-02

    Omnipod 5 iOS App software design issue causes insulin overdose risk

    Insulet Corporation is recalling the Omnipod 5 iOS App due to a software issue where decimal separators are not recognized in manual insulin entry, potentially causing insulin overdose and severe hypoglycemia.

    Product
    Omnipod 5 Automated Insulin Delivery System, iOS Application. Model Number: PT-000664/M009-S-AP. Software Version: all Product Description: The Omnipod 5 iOS App software is available to download through the Apple app store. The Omnipod 5 App is the user interface t
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-1945-2025·2025-06-25

    Dexcom One+ Continuous Glucose Monitoring System Receiver Speaker Defect

    Dexcom, Inc. is recalling 26,291 units of the Dexcom One+ Continuous Glucose Monitoring System due to defective foam or assembly errors that may prevent audible alerts for low or high blood glucose levels, potentially leading to seizures, loss of consciousness, or death.

    Product
    Dexcom One+ Continuous Glucose Monitoring System, SKU(Part Number): STK-D7-013 (MT28285-1), STK-D7-014 (MT28285-1), STK-D7-103 (MT28285-2)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1944-2025·2025-06-25

    Dexcom G7 Glucose Receiver recalled due to defective foam or assembly error

    Dexcom, Inc. is recalling Dexcom G7 Glucose Receiver units due to defective foam or assembly error that may cause the speaker to lose contact with the circuit board, preventing audible alerts for low or high blood glucose.

    Product
    Dexcom G7 Glucose Receiver, SKUs (part number): STK-AT-011(MT26403-0), STK-AT-012 (MT26403-0), STK-AT-013 (MT26403-0), STK-GT-001 (MT26403-1), STK-GT-008 (MT26403-5), STK-GT-013 (MT26403-1) , STK-GT-019 (MT26403-4) , STK-GT-100 (MT26403-2), STK-GT-109 (MT26403-2) , STK-GT-113 (
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1946-2025·2025-06-25

    Dexcom One Continuous Glucose Monitoring System Receiver Speaker Defect

    Dexcom, Inc. is recalling Dexcom One Continuous Glucose Monitoring System receivers due to potential defective foam or assembly errors that may cause the speaker to lose contact with internal components, resulting in missed audible alerts for dangerous blood glucose levels.

    Product
    Dexcom One Continuous Glucose Monitoring System, SKUs(Part Number): STK-DO-006 (MT27409-1), STK-DO-013 (MT27409-1), STK-DO-103 (MT27409-2), STK-DO-109 (MT27409-2)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1519-2025·2025-04-23

    t:slim X2 Insulin Pump Software Defect Affecting Glucose Delivery

    Tandem Diabetes Care is recalling 63 units of the t:slim X2 Insulin Pump with software version 7.9 due to a defect that can cause incorrect insulin delivery. The defect may lead to dangerous blood sugar levels when glucose monitoring loses connection.

    Product
    t:slim X2 Insulin Pump with Interoperable Technology
    Category
    Medical Device
    Distribution
    29 states
  • SevereFDA (Devices)·Z-1520-2025·2025-04-23

    Tandem Mobi Insulin Pump Software Defect Risks Incorrect Insulin Delivery

    Tandem Diabetes Care is recalling Tandem Mobi Insulin Pumps with software version 7.9 due to a defect that can cause incorrect insulin delivery when glucose data gaps occur, potentially leading to severe high or low blood sugar.

    Product
    Tandem Mobi Insulin Pump with Interoperable Technology
    Category
    Medical Device
    Distribution
    29 states
  • CriticalFDA (Devices)·Z-1257-2025·2025-03-12

    Insulin pump recall: Medtronic Paradigm models malfunction during airplane flight

    Medtronic MiniMed's Paradigm insulin pumps can malfunction during airplane flight due to air pressure changes, potentially causing dangerously high or low blood sugar levels that could be fatal.

    Product
    Paradigm insulin pump, REF: MMT-754
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1263-2025·2025-03-12

    Insulin Pump Recalled for Abnormal Delivery During Flight Pressure Changes

    Medtronic MiniMed 720G insulin pumps may malfunction during airplane travel due to air pressure changes, causing abnormal insulin doses that can lead to severe low or high blood sugar emergencies.

    Product
    MiniMed insulin pump, REF: 720G (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1259-2025·2025-03-12

    MiniMed Insulin Pumps Recalled for Abnormal Insulin Delivery During Flight

    MiniMed insulin pumps may deliver abnormal insulin doses during aircraft takeoff and landing due to air pressure changes, risking severe blood sugar fluctuations, seizures, and potentially fatal complications.

    Product
    MiniMed insulin pump, REF: 630G (MMT-1714, MMT-1715, MMT-1754, MMT-1755)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1264-2025·2025-03-12

    MiniMed Insulin Pump Models Recalled for Abnormal Delivery During Flight

    Medtronic is recalling MiniMed insulin pumps due to air pressure changes during airplane takeoff and landing that can cause abnormal insulin delivery. Overdoses risk severe hypoglycemia; underdoses risk severe hyperglycemia and diabetic ketoacidosis.

    Product
    MiniMed insulin pump, REF: 740G (MMT-1811, MMT-1812, MMT-1861, MMT-1862)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1266-2025·2025-03-12

    Medtronic MiniMed insulin pumps may deliver abnormal insulin doses during flight

    Medtronic MiniMed insulin pumps may deliver abnormal doses of insulin during airplane takeoff or landing due to air pressure changes. This can result in severe hypoglycemia or hyperglycemia, with potential for seizure, coma, or death.

    Product
    MiniMed insulin pump, REF: 780G (MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT-1896)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1255-2025·2025-03-12

    Medtronic Paradigm insulin pumps may deliver incorrect doses during flight

    Medtronic MiniMed insulin pumps may deliver abnormally high or low insulin doses in response to air pressure changes during airplane takeoff and landing, potentially causing severe hypoglycemia or hyperglycemia.

    Product
    Paradigm REF: MMT-712 and MMT-715
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1256-2025·2025-03-12

    Medtronic Paradigm insulin pump recall for abnormal delivery during flight

    Medtronic MiniMed Paradigm insulin pumps may deliver incorrect insulin doses during airplane takeoff or landing due to air pressure changes. This can cause severe high or low blood sugar requiring immediate medical attention.

    Product
    Paradigm insulin pump, REF: MMT-522, MMT-523, MMT-551, MMT-722, MMT-723, MMT-751
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1260-2025·2025-03-12

    Medtronic MiniMed Insulin Pumps Recalled for Abnormal Delivery During Air Pressure Changes

    Medtronic is recalling MiniMed insulin pumps that malfunction during airplane takeoff and landing due to air pressure changes. The defect can cause abnormal insulin delivery, leading to severe hypoglycemia, hyperglycemia, seizure, coma, or death.

    Product
    MiniMed insulin pump, REF: 640G (MMT-1711, MMT-1712, MMT-1751, MMT-1752)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0194-2023·2022-11-16

    Insulin Pump Cybersecurity Vulnerability Allows Unauthorized Remote Access

    MiniMed 600 series insulin pumps have a cybersecurity vulnerability that could allow unauthorized access, potentially resulting in delivery of too much or too little insulin. Users should disable the Remote Bolus feature.

    Product
    Insulin Pump/Model: MiniMed 620G/ MMT-1750 MiniMed 640G/ MMT-1711, MMT-1712, MMT-1751, MMT-1752
    Category
    Medical Device
    Distribution
    54 states
  • HighFDA (Devices)·Z-1812-2022·2022-10-05

    t:slim X2 Insulin Pumps Recalled for Software Issues Affecting Blood Sugar Management

    Tandem Diabetes Care is recalling approximately 8,399 t:slim X2 insulin pumps due to software malfunctions that may affect blood sugar control. A software update is available to resolve the issues.

    Product
    t:slim X2 insulin pump; t:slim X2 insulin pump with Dexcom G5; t:slim X2 insulin pump with Basal-IQ technology; t: slim x2 insulin pump with the Control-IQ Technology
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-1203-2021·2021-03-17

    Insulet Recalls Omnipod DASH User Guides Due to Decimal Error

    Insulet Corporation is recalling 21,723 Omnipod DASH User Guides distributed outside the US due to a misprint regarding decimal separators that could lead to incorrect bolus delivery.

    Product
    Omnipod DASH Insulin Management System User Guide (OUS Only) Product Catalog Number: PT 000002 XXX XXX XX PT 000318 PT 000319 Distributed to: Canada (French only), the Netherlands, France, Austria, Germany, Belgium, Greece, Turkey, Norway, Sweden, Denmark, and Finland
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0101-2021·2020-10-21

    Siemens ADVIA Fructosamine Test Recalled for Positive Bias

    Siemens is recalling ADVIA Chemistry Systems-Fructosamine tests because results may show a positive bias, potentially leading to incorrect glucose management.

    Product
    ADVIA Chemistry Systems-Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA Chemistry systems Siemens Material Number (SMN): 10361941
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0102-2021·2020-10-21

    Siemens Atellica CH Fructosamine Test Recall for Positive Bias

    Siemens is recalling Atellica CH Fructosamine tests because results may show a positive bias, potentially leading to incorrect glucose management and hypoglycemia.

    Product
    Atellica CH Systems Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA¿ Chemistry systems Siemens Material Number (SMN): 11097637
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-1553-2020·2020-04-01

    Insulet Omnipod DASH PDM Recalled for Inaccurate Bolus Suggestions

    Insulet is recalling Omnipod DASH Personal Diabetes Manager devices because they may suggest inaccurate bolus amounts, potentially leading to hypoglycemia or hyperglycemia.

    Product
    Omnipod DASH Personal Diabetes Manager (PDM), Catalog numbers US: 18239 M/D: PDM-USA1-D001-MG-USA1 EU: PT-000010 - M/D: INT1-D001-MG PT-000011 M/D: INT1-D001-MM UDI 10385082000009 The Omnipod DASH Personal Diabetes Manager (PDM) is a mobile, handheld Android
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0958-2020·2020-02-19

    Medtronic MiniMed 640G Insulin Pump Recall for Loose Reservoir Risk

    Medtronic is recalling specific 640G insulin pumps due to a loose reservoir that may cause incorrect insulin delivery.

    Product
    Medtronic MiniMed 640G Insulin Infusion Pump, Ref#s/Model(s) - MMT-1511, MMT-1711, MMT-1512, MMT-1712, MMT-1751, and MMT-1752 *Not for US Distribution
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-0955-2020·2020-02-19

    Medtronic MiniMed 630G System Recalled for Loose Reservoir Defect

    Medtronic is recalling MiniMed 630G Systems with SmartGuard because a broken or missing retainer ring can cause the insulin reservoir to become loose, leading to incorrect insulin delivery.

    Product
    Medtronic MiniMed 630G System with SmartGuard, Ref/Model # MMT-1515, MMT-1715, MMT-1714, MMT-1754, and MMT-1755 *US and Canada Version Only
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-0956-2020·2020-02-19

    Medtronic MiniMed 670G System Recalled for Loose Insulin Reservoir

    Medtronic is recalling MiniMed 670G Systems with SmartGuard because a broken or missing retainer ring can cause the insulin reservoir to become loose, leading to incorrect insulin delivery.

    Product
    Medtronic MiniMed 670G System with SmartGuard, Ref #s/Model Number(s) - MMT-1741, MMT-1742, MMT-1760, MMT-1761, MMT-1762, MMT-1580, MMT-1581, MMT-1582, MMT-1780, MMT-1781, and MMT-1782
    Category
    Medical Device
    Distribution
    52 states