The Recall Desk

Hazard

Hyperglycemia recalls

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

What the numbers show

Total
32
Critical
6
Severe
11
Most recent
2026-07-29

Of the 32 hyperglycemia recalls we have scored against our rubric, 6 (19%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 11 (34%) 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 hyperglycemia 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 32

  • HighFDA (Devices)·Z-2778-2026·2026-07-29

    MiniMed Go App Recalled Due to Missed Insulin Alerts

    Medtronic is recalling its MiniMed Go app because a software bug can prevent insulin dose alerts during nighttime, potentially leading to missed doses and hyperglycemia.

    Product
    MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2513-2026·2026-06-24

    iLet Bionic Pancreas pumps may become stuck on the lock screen

    The iLet Bionic Pancreas is being recalled because a screen unlock failure can leave the user stuck on the Lock Screen, unable to change the cartridge or announce a meal.

    Product
    iLet Bionic Pancreas, REF: BB1001
    Category
    Medical Device
    Distribution
    51 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
  • CriticalFDA (Devices)·Z-0427-2026·2025-11-12

    Insulin pumps recalled over false vibration motor failure stopping delivery

    Tandem Diabetes Care is recalling 17,745 Tandem Mobi insulin pumps because a software issue can trigger a false vibration motor failure that halts insulin delivery. The FDA classified it Class I.

    Product
    Tandem Mobi Insulin Pump: Description/Catalog: Tandem insulin 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,
    Category
    Medical Device
    Distribution
    53 states
  • CriticalFDA (Devices)·Z-2343-2025·2025-09-03

    Insulin pumps recalled over malfunction that stops insulin delivery and alerts

    Tandem t:slim X2 insulin pumps built with Revision A and B speakers may hit Malfunction 16, losing audible alerts and stopping insulin delivery. The FDA classified the action as Class I. 171,750 units are affected.

    Product
    Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911; t:slim X2 GS Classic, Replacement, Refurbished, REF: 1003808; t: slim X2, Basal-IQ, mg/dl, REF: 1004219; Pump, t:slim X2, Clinical Use Only, REF: 1004484; Pump, t:slim X2, Control-IQ, REF:
    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-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-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
  • SevereFDA (Devices)·Z-0003-2025·2024-10-09

    MiniMed Insulin Pumps May Stop Delivering Insulin After Physical Impact

    Medtronic MiniMed insulin pumps (670G, 770G, 780G) that have been dropped or bumped may develop internal battery defects causing premature failure and interrupted insulin delivery, risking dangerously high blood sugar.

    Product
    MiniMed Insulin Pump Device. MiniMed 670G, REF: MMT-1580, MMT-1581, MMT-1582, MMT-1780, MMT-1781, MMT-1782, MMT-1740, MMT-1741, MMT-1742, MMT-1760, MMT-1761, MMT-1762; MiniMed 770G, REF: MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892; MiniMed 780G, REF: MMT-1884, MM
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-2174-2024·2024-07-03

    Blood Glucose Meter Recall: Accu-Chek Guide May Display Incorrect Measurement Units

    Roche is recalling Accu-Chek Guide (SC) blood glucose meters that may display readings in mmol/L instead of mg/dL, appearing approximately 18 times lower than actual. This could lead to incorrect treatment decisions and long-term diabetes complications.

    Product
    Accu-Chek Guide (SC) Kit -Intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid in monitoring the effectiveness of glucose control. Product REF Number: 08453071001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1609-2024·2024-05-15

    Insulin pump app may crash and drain battery, risking insulin delivery interruption

    Tandem's t:connect app version 2.7+ may crash repeatedly, draining the insulin pump battery faster than expected and potentially interrupting insulin delivery.

    Product
    t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0233-2024·2023-11-29

    VariSoft Infusion Set Model 1002828 Recalled for Connector Detachment Risk

    The FDA recalls 1,679 VariSoft infusion sets (Model 1002828) due to connector damage that causes improper detachment. Undetected disconnections can lead to missed insulin doses and diabetic ketoacidosis.

    Product
    VariSoft infusion set, Model Number 1002828
    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-0855-2022·2022-04-06

    Medtronic MiniMed insulin pumps may not deliver basal insulin without configuration

    Medtronic MiniMed insulin pumps may be used without programmed basal rates, causing insulin under-delivery and potentially severe high blood sugar. Patients must configure and save basal settings before use, but labeling doesn't clearly explain this requirement.

    Product
    MiniMed 630G: MMT-1715, MMT-1754, MMT-1755; MiniMed 670G: MMT-1740, MMT-1741, MMT-1742, MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, MMT-1782; MiniMed 770G: MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892; MiniMed 620G (OUS Only): MMT-1750; MiniMed 640G (OUS O
    Category
    Medical Device
    Distribution
    53 states