Insulin Pumps & Glucose Monitors recalls

465 medical device recalls in the insulin pumps & glucose monitors category are on file with the FDA, from 2012 to 6 Oct 2026.

Total recalls465since 2012
Last 12 months51reported
Class I8719% of total
Ongoing202latest 6 Oct 2026

Recalls per month, last 24 months

click a bar for that month

Severity split

Class I 87 19%Class II 352 76%Class III 25 5%Other/pending 1

Why insulin pumps & glucose monitors is recalled

By year

Ongoing insulin pumps & glucose monitors recalls

202 active

All insulin pumps & glucose monitors recalls, newest first

465 total
ReportedClassRecallCompanyReasonWhere
DeviceANNOUNCEDStatStrip Glucose Hospital Meter System recalled by Nova BiomedicalNova Biomedical StatStripNova BiomedicalDevice Malfunction
DeviceCLASS IStatStrip Glucose Hospital Meter System recalled by Nova BiomedicalNova BiomedicalDevice MalfunctionNationwide
DeviceCLASS IStatStrip Glucose and B- Ketone meter recalled by Nova BiomedicalNova BiomedicalDevice MalfunctionNationwide
DeviceCLASS IStatStrip Glucose Hospital Meter System recalled by Nova BiomedicalNova BiomedicalDevice MalfunctionNationwide
DeviceCLASS IStatStrip Glucose and B- Ketone meter recalled by Nova BiomedicalNova BiomedicalDevice MalfunctionNationwide
DeviceCLASS IStatStrip Glucose and B- Ketone meter recalled by Nova BiomedicalNova BiomedicalDevice MalfunctionNationwide
DeviceCLASS IIMiniMed Insulin Pump recalled by Medtronic MiniMedMedtronic MiniMedOtherCA
DeviceCLASS IIMiniMed Insulin Pump recalled by Medtronic MiniMedMedtronic MiniMedOtherCA
DeviceCLASS IIMiniMed Insulin Pump recalled by Medtronic MiniMedMedtronic MiniMedOtherCA
DeviceCLASS IIMiniMed Insulin Pump recalled by Medtronic MiniMedMedtronic MiniMedDevice MalfunctionCA
DeviceCLASS IOmnipod (Eros) Pod recalled by InsuletInsuletPackaging DefectsNationwide
DeviceCLASS IOmnipod DASH Pod recalled by InsuletInsuletPackaging DefectsNationwide
DeviceCLASS IOmnipod 5 Pods recalled by InsuletInsuletPackaging DefectsNationwide
DeviceCLASS IIG7 Continuous Glucose Monitoring System Dexcom G7 US Retail recalledDexcomDevice MalfunctionCA
DeviceCLASS IISporetraq Mail-in Spore Testing Service, 12 Tests recalledHF AcquisitionDevice MalfunctionNationwide
DeviceCLASS IISporetraq Mail-in Spore Testing Service, 52 Tests recalledHF AcquisitionDevice MalfunctionNationwide
DeviceCLASS IIONE+ iOS CGM App recalled by DexcomDexcomDevice MalfunctionNationwide
DeviceCLASS IIG7 Continuous Glucose Monitoring System Dexcom G7 CGM iOS App recalledDexcomDevice MalfunctionNationwide
DeviceCLASS IIG7 Continuous Glucose Monitoring System Dexcom G7 CGM watchOS App recalledDexcomDevice MalfunctionNationwide
DeviceCLASS IAIDBAGs are first aid kits of convenience composed recalledNorth American RescueDevice MalfunctionCA, WA
DeviceCLASS IOmnipod 5 Pods recalled by InsuletInsuletPackaging DefectsNationwide
DeviceCLASS IIMiniMed Insulin Pump (Mmt-1760, Mmt-1761, Mmt recalledMedtronic MiniMedOtherNationwide
DeviceCLASS IIMiniMed Insulin Pump (Mmt-1801, Mmt-1805, Mmt-1850, Mmt-1851) recalledMedtronic MiniMedOtherNationwide
DeviceCLASS IIMiniMed Insulin Pump (Mmt-1880, Mmt-1881, Mmt recalledMedtronic MiniMedOtherNationwide
DeviceCLASS IIMiniMed Insulin Pump (Mmt-1714, Mmt-1715, Mmt-1754, Mmt-1755) recalledMedtronic MiniMedOtherNationwide
DeviceCLASS IIMiniMed Insulin Pump (Mmt-1711, Mmt-1712, Mmt-1751, Mmt-1752) recalledMedtronic MiniMedOtherNationwide
DeviceCLASS IIMiniMed Insulin Pump (Mmt-1884, Mmt-1885, Mmt recalledMedtronic MiniMedOtherNationwide
DeviceCLASS IIMiniMed Insulin Pump (Mmt-551, Mmt-751) recalled by Medtronic MiniMedMedtronic MiniMedOtherNationwide
DeviceCLASS IIParadigm Real-Time Revel Insulin Pump (Mmt-523, Mmt-723) recalledMedtronic MiniMedOtherNationwide
DeviceCLASS IIMiniMed Insulin Pump (Mmt-1811, Mmt-1812, Mmt-1861, Mmt-1862) recalledMedtronic MiniMedOtherNationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.