Category

Diabetes Devices Recalls

295 diabetes devices recalls on record from CPSC, FDA, and USDA.

295 recalls
CriticalFDA
North American Rescue Llc.
AIDBAGs are first aid kits of convenience composed of individually labeled devices designed as specialty first aid kits designed for the ...
Diabetes Devices·21 affected·Mar 27, 2026
CriticalFDA
Medtronic Minimed, Inc.
MiniMed 720G Insulin Pump (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867)
Diabetes Devices·37,458 affected·Feb 13, 2026
CriticalFDA
Medtronic Minimed, Inc.
Paradigm REAL-Time Insulin Pump (MMT-522, MMT-722)
Diabetes Devices·29,074 affected·Feb 13, 2026
CriticalFDA
Medtronic Minimed, Inc.
Paradigm REAL-Time Veo Insulin Pump (MMT-554, MMT-754)
Diabetes Devices·55,724 affected·Feb 13, 2026
CriticalFDA
Medtronic Minimed, Inc.
MiniMed 620G Insulin Pump (MMT-1750)
Diabetes Devices·799 affected·Feb 13, 2026
CriticalFDA
Medtronic Minimed, Inc.
Paradigm Insulin Pump (MMT-712, MMT-715)
Diabetes Devices·73,656 affected·Feb 13, 2026
CriticalFDA
Medtronic Minimed, Inc.
MiniMed 740G Insulin Pump (MMT-1811, MMT-1812, MMT-1861, MMT-1862)
Diabetes Devices·24,946 affected·Feb 13, 2026
CriticalFDA
Medtronic Minimed, Inc.
Paradigm REAL-Time Revel Insulin Pump (MMT-523, MMT-723)
Diabetes Devices·26,647 affected·Feb 13, 2026
CriticalFDA
Medtronic Minimed, Inc.
MiniMed 530G Insulin Pump (MMT-551, MMT-751)
Diabetes Devices·13,429 affected·Feb 13, 2026
CriticalFDA
Medtronic Minimed, Inc.
MiniMed 780G Insulin Pump (MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT-1896)
Diabetes Devices·453,144 affected·Feb 13, 2026
CriticalFDA
Medtronic Minimed, Inc.
MiniMed 640G Insulin Pump (MMT-1711, MMT-1712, MMT-1751, MMT-1752)
Diabetes Devices·116,645 affected·Feb 13, 2026
CriticalFDA
Medtronic Minimed, Inc.
MiniMed 630G Insulin Pump (MMT-1714, MMT-1715, MMT-1754, MMT-1755)
Diabetes Devices·60,880 affected·Feb 13, 2026
CriticalFDA
Trividia Health, Inc.
Owner's Booklets and Instructions for Use that are used with the following blood glucose measurement devices. Description/Item: TRUE ME...
Diabetes Devices·1,001,534 affected·Feb 6, 2026
CriticalFDA
Trividia Health, Inc.
Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description/Item: Walgreens...
Diabetes Devices·3,678,026 affected·Feb 6, 2026
CriticalFDA
Trividia Health, Inc.
Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description/Item: Walgreens...
Diabetes Devices·1,407,465 affected·Feb 6, 2026
High RiskFDA
Tandem Diabetes Care, Inc.
Tandem pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize a motor-driven me...
Diabetes Devices·1,380 affected·Jan 30, 2026
CriticalFDA
Abbott Diabetes Care, Inc.
FreeStyle Libre 3 Sensor REF 72081-01 UDI-DI code: 00357599818005 The FreeStyle Libre 3 sensor is a component of the FreeStyle Libre 3 C...
Diabetes Devices·1,060,723 affected·Nov 24, 2025
High RiskFDA
Get Tested International Ab
Diabetes HbA1c Test
Diabetes Devices·148 affected·Nov 3, 2025
High RiskFDA
Medtronic Minimed, Inc.
MiniMed 780G Insulin Pump Catalog Numbers: MMT-1884 MMT-1886 With Software Version 6.60 The MiniMed 780G insulin pump is indicated ...
Diabetes Devices·577 affected·Nov 2, 2025
High RiskFDA
Trividia Health, Inc.
Good Neighbor Pharmacy, TRUE METRIX Self Monitoring Blood Glucose Meter. Model/Catalog Number: RE4011-01.
Diabetes Devices·601 affected·Oct 7, 2025
CriticalFDA
Dexcom, Inc.
Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dexcom G6 and G6 Pro Android US CGM App Model/Catalog Number: ...
Diabetes Devices·333 affected·Aug 28, 2025
High RiskFDA
Tandem Diabetes Care, Inc.
t:slim X2 insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014070, 1014071, 1014072, 1014073, and User Guide whe...
Diabetes Devices·122,958 affected·Aug 5, 2025
CriticalFDA
Dexcom, Inc.
Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM Android App Model/Catalog Number: SW12299 Softw...
Diabetes Devices·532,821 affected·Jul 24, 2025
CriticalFDA
Dexcom, Inc.
Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ Android CGM App Model/Catalog Number: SW14245 S...
Diabetes Devices·41,629 affected·Jul 24, 2025
CriticalFDA
Dexcom, Inc.
Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM watchOS App Model/Catalog Number: SW13355 Softw...
Diabetes Devices·907,842 affected·Jul 24, 2025
CriticalFDA
Dexcom, Inc.
Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ iOS CGM App Model/Catalog Number: SW14244 Softw...
Diabetes Devices·39,309 affected·Jul 24, 2025
High RiskFDA
Reflexion Medical, Inc.
RefleXion X1 Model RXM1000 UDI Codes: (01)00860003983812(11)230504(21)X11001 (01)00860003983812(11)230518(21)X11002 (01)0086000398381...
Diabetes Devices·11 affected·Jul 22, 2025
High RiskFDA
Tandem Diabetes Care, Inc.
t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app)
Diabetes Devices·19 affected·Jul 3, 2025
High RiskFDA
Hemocue Ab
The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 (or DM) Analyzer with plasma conversion that mult...
Diabetes Devices·4 affected·May 12, 2025
CriticalFDA
Dexcom, Inc.
Dexcom One+ Continuous Glucose Monitoring System, SKU(Part Number): STK-D7-013 (MT28285-1), STK-D7-014 (MT28285-1), STK-D7-103 (MT28285-2)
Diabetes Devices·26,291 affected·May 12, 2025
CriticalFDA
Dexcom, Inc.
Dexcom One Continuous Glucose Monitoring System, SKUs(Part Number): STK-DO-006 (MT27409-1), STK-DO-013 (MT27409-1), STK-DO-103 (MT274...
Diabetes Devices·38,127 affected·May 12, 2025
High RiskFDA
Dexcom, Inc.
Dexcom G7 iOS Application, Ref: SW12300 used in conjunction with the Dexcom G7 Continuous Glucose Monitoring (CGM) system
Diabetes Devices·61,355 affected·May 5, 2025
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
HEMOCUE INC F/GLUCOSE 201 ANALYZER (25/VL 4VL/BX) MICROCUVETTE.
Diabetes Devices·4 affected·Apr 24, 2025
High RiskFDA
Medtronic Minimed, Inc.
InPen smart insulin pen, REF: MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA, MMT-105ELBLNA, MMT-105ELGYNA, MMT105ELPKNA
Diabetes Devices·8,986 affected·Mar 4, 2025
CriticalFDA
Tandem Diabetes Care, Inc.
t:slim X2 Insulin Pump with Interoperable Technology
Diabetes Devices·63 affected·Feb 27, 2025
CriticalFDA
Medtronic Minimed, Inc.
MiniMed insulin pump, REF: 770G (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892)
Diabetes Devices·106,289 affected·Jan 31, 2025
CriticalFDA
Medtronic Minimed, Inc.
MiniMed insulin pump, REF: 630G (MMT-1714, MMT-1715, MMT-1754, MMT-1755)
Diabetes Devices·70,587 affected·Jan 31, 2025
CriticalFDA
Medtronic Minimed, Inc.
MiniMed insulin pump, REF: 720G (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867)
Diabetes Devices·8,677 affected·Jan 31, 2025
CriticalFDA
Medtronic Minimed, Inc.
MiniMed insulin pump, REF: 620G (MMT-1750)
Diabetes Devices·228 affected·Jan 31, 2025
CriticalFDA
Medtronic Minimed, Inc.
Paradigm insulin pump, REF: MMT-754
Diabetes Devices·41,404 affected·Jan 31, 2025
CriticalFDA
Medtronic Minimed, Inc.
MiniMed insulin pump, REF: 640G (MMT-1711, MMT-1712, MMT-1751, MMT-1752)
Diabetes Devices·168,240 affected·Jan 31, 2025
CriticalFDA
Medtronic Minimed, Inc.
Paradigm insulin pump, REF: MMT-522, MMT-523, MMT-551, MMT-722, MMT-723, MMT-751
Diabetes Devices·46,437 affected·Jan 31, 2025
High RiskFDA
Dexcom, Inc.
Dexcom G6, Continuous Glucose Monitoring System, REF: STK-OR-001
Diabetes Devices·0 affected·Jan 27, 2025
High RiskFDA
Dexcom, Inc.
Dexcom G6, Continuous Glucose Monitoring System, REFs: STK-OM-001, STR-OM-001, STR-OR-001
Diabetes Devices·0 affected·Jan 27, 2025
CriticalFDA
Nova Biomedical Corporation
StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use blood glucose meter for near-patient testing.
Diabetes Devices·2,365 affected·Nov 20, 2024
CriticalFDA
Nova Biomedical Corporation
StatStrip Glucose Ketone (mmol/L) Hospital Meter System. Model/Catalog Number: 63910. Prescription use blood glucose ketone meter for nea...
Diabetes Devices·1,615 affected·Nov 20, 2024
High RiskFDA
Drg International, Inc.
DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361
Diabetes Devices·10 affected·Oct 7, 2024
CriticalFDA
Cardinal Health 200, Llc
Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack, REF 1188100777
Diabetes Devices·371,326 affected·Sep 25, 2024