Category

Diabetes Devices Recalls

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

295 recalls
High RiskFDA
Healgen Scientific Llc
Healgen Series Reagent strips for Urinalysis are composed of several color pads aligned on a test strip. Each pad is employed for testing...
Diabetes Devices·1,636,994 affected·Aug 22, 2024
CriticalFDA
Medtronic Minimed, Inc.
MiniMed 620G Insulin Pump, REF: MMT-1510, MMT-1710, MMT-1750; MiniMed 630G Insulin Pump, REF: MMT-1515, MMT-1714, MMT-1715, MMT-1754, MM...
Diabetes Devices·234,360 affected·Jul 31, 2024
CriticalFDA
Abbott Diabetes Care, Inc.
FreeStyle Libre 3 Sensors, REF: 72081-01, component of the FreeStyle Libre 3 Continuous Glucose Monitoring System
Diabetes Devices·8,174 affected·Jul 24, 2024
High RiskFDA
Macherey Nagel Gmbh & Co. Kg
Reagent Test Strips for Blood, Urobilinogen, Bilirubin, Protein, Nitrite, Ketones, Ascorbic Acid, Glucose, pH, Specific Gravity and Leuco...
Diabetes Devices·5,200 affected·Apr 4, 2024
CriticalFDA
Tandem Diabetes Care, Inc.
t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology
Diabetes Devices·85,863 affected·Mar 5, 2024
CriticalFDA
Insulet Corporation
Omnipod 5 App (on compatible Android smartphones), Software Versions 1.1 - 1.2.3 (current). US: PT-000599- Omnipod 5 App Software Packag...
Diabetes Devices·27,000 affected·Nov 30, 2023
High RiskFDA
Beckman Coulter, Inc.
Access Ultrasensitive Insulin only used on the DxI 9000 Access Immunoassay Analyzer, Catalog Number 33410
Diabetes Devices·19,125 affected·Nov 21, 2023
High RiskFDA
Inmar Supply Chain Solutions, Llc
Various Medical Products stored on pallets, including but not limited to bandages, tampons, condoms, blood glucose monitors, adult diaper...
Diabetes Devices·0 affected·Aug 24, 2023
High RiskFDA
Ascensia Diabetes Care Us, Inc.
Contour¿ next GEN Blood Glucose Monitoring System
Diabetes Devices·2,888 affected·May 19, 2023
High RiskFDA
Insulet Corporation
Omnipod 5 Automated Insulin Delivery System
Diabetes Devices·11,016 affected·Feb 28, 2023
CriticalFDA
Abbott Diabetes Care, Inc.
FreeStyle Libre Reader, REF: 71951-01, 71952-01, 71953-01 a component of the FreeStyle Libre 2 Flash Glucose Monitoring System
Diabetes Devices·1,534,532 affected·Feb 13, 2023
CriticalFDA
Abbott Diabetes Care, Inc.
FreeStyle Libre Reader, REF: 71936-01, 71937-01, 71938-01 a component of the FreeStyle Libre 14 Day Flash Glucose Monitoring System
Diabetes Devices·1,373,311 affected·Feb 13, 2023
High RiskFDA
Becton Dickinson & Company
BD Ultra-Fine Insulin Syringe 0.5mL, 8mm, 31G-Insulin Syringes are designed for administering insulin in the treatment of diabetes mellit...
Diabetes Devices·1,129,000 affected·Feb 1, 2023
High RiskFDA
Becton Dickinson & Company
BD Insulin Syringes with the BD Micro-Fine IV Needle 0.5ml, 12.7mm, 28G Single Unit Scale-Insulin Syringes are designed for administering...
Diabetes Devices·686,500 affected·Feb 1, 2023
High RiskFDA
Becton Dickinson & Company
BD Ultra-Fine Insulin Syringe 0.5mL, 6mm, 31G - Insulin Syringes are designed for administering insulin in the treatment of diabetes mell...
Diabetes Devices·45 affected·Feb 1, 2023
High RiskFDA
Becton Dickinson & Company
BD Ultra-Fine II Insulin Syringe 0.5mL, 8mm, 30G-Insulin Syringes are designed for administering insulin in the treatment of diabetes mel...
Diabetes Devices·1,472,400 affected·Feb 1, 2023
High RiskFDA
Becton Dickinson & Company
BD Insulin Syringes with the BD Micro-Fine IV Needle 1 ml, 12. 7mm, 28G Two Unit Scale- Insulin Syringes are designed for administering ...
Diabetes Devices·1,921,000 affected·Feb 1, 2023
High RiskFDA
Becton Dickinson & Company
BD Ultra-Fine Insulin Syringe 1mL, 12.7mm, 29G-Insulin Syringes are designed for administering insulin in the treatment of diabetes melli...
Diabetes Devices·80,500 affected·Feb 1, 2023
High RiskFDA
Becton Dickinson & Company
BD Ultra-Fine Insulin Syringe 1mL, 6mm, 31G-Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus...
Diabetes Devices·1,168,000 affected·Feb 1, 2023
CriticalFDA
Insulet Corporation
18239: ASM Omnipod Dash PDM, insulin delivery system. PT-000010: Assembly, Dash Final PDM U100, mg/dL PT-000011: Assembly, Dash Final...
Diabetes Devices·248,288 affected·Oct 17, 2022
High RiskFDA
Medtronic Minimed
Insulin Pump/Model: MiniMed 620G/ MMT-1750 MiniMed 640G/ MMT-1711, MMT-1712, MMT-1751, MMT-1752
Diabetes Devices·316,326 affected·Sep 20, 2022
High RiskFDA
Medtronic Minimed
Insulin Pump/Model: MiniMed 630G/ MMT-1715, MMT-1755, MMT-1754; MiniMed 670G/ MMT-1780, MMT-1781, MMT-1782, MMT-1760, MMT-1761, MMT-17...
Diabetes Devices·399,651 affected·Sep 20, 2022
High RiskFDA
Unomedical A/s
Autosoft 90, model numbers 1000282, 1002817, 1002818, 1002819, 1002820, 1002821, 1002822, 1002823, and 1002824. Infusion sets used with ...
Diabetes Devices·1,643,320 affected·Jul 21, 2022
High RiskFDA
Alere San Diego, Inc.
The Cholestech LDX¿ System combines enzymatic methodology and solidphase technology to measure total cholesterol, HDL cholesterol, trigl...
Diabetes Devices·436,990 affected·Jun 24, 2022
High RiskFDA
Tandem Diabetes Care Inc
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 w...
Diabetes Devices·31,100 affected·May 24, 2022
High RiskFDA
Tandem Diabetes Care Inc
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 w...
Diabetes Devices·8,399 affected·May 24, 2022
High RiskFDA
Medtronic Minimed
MiniMed 640G Insulin Pump (O.U.S. Version)
Diabetes Devices·323,417 affected·May 23, 2022
High RiskFDA
Medtronic Minimed
MiniMed 740G Insulin Pump (O.U.S. Version)
Diabetes Devices·40 affected·May 23, 2022
High RiskFDA
Medtronic Minimed
MiniMed 670G Insulin Pump (U.S. and O.U.S. Version)
Diabetes Devices·279,251 affected·May 23, 2022
High RiskFDA
Medtronic Minimed
MiniMed 720G Insulin Pump (O.U.S. Version)
Diabetes Devices·575 affected·May 23, 2022
High RiskFDA
Medtronic Minimed
MiniMed 780G Insulin Pump (O.U.S. Version)
Diabetes Devices·83,398 affected·May 23, 2022
High RiskFDA
Roche Diagnostics Operations, Inc.
Cobas u 601 urinalysis test system, Catalog number 06334601001 The cobas U 601 urinalysis test system is comprised of the cobas u 601 ur...
Diabetes Devices·636 affected·Oct 18, 2021
High RiskFDA
Roche Diabetes Care, Inc.
Accu-Chek Performa Test Strip, Blood Glucose Monitoring System, Model number 07299702001
Diabetes Devices·146,854 affected·Jul 28, 2021
High RiskFDA
Roche Diabetes Care, Inc.
Accu-Chek Aviva Plus Test Strip, Blood Glucose Monitoring System, Model numbers: 06908152001, 06908217001, 06908268001, 06908349001, 0690...
Diabetes Devices·10,546,420 affected·Jul 28, 2021
High RiskFDA
Cardinal Health Inc.
FREESTYLE LIBRE 2 GLUCOSE MONITORING SYSTEM: Item number: 5658877
Diabetes Devices·2,115 affected·Mar 16, 2021
High RiskFDA
Cardinal Health Inc.
FREESTYLE LIBRE 14 DAY GLUCOSE MONITORING SYSTEM. Item Number: 5479084
Diabetes Devices·8,959 affected·Mar 16, 2021
High RiskFDA
Medtronic Minimed
MiniMed 670G Insulin Pump: Models: PUMP MMT-1740KX 670G V6.3 SF MG CLIN;¿ PUMP MMT-1740KX 670G V6.3 CLIN 020 MG;¿ PUMP MMT-1741KFX 67...
Diabetes Devices·1,266 affected·Mar 15, 2021
High RiskFDA
Medtronic Inc.
Medtronic REF: MMT-7020C Guardian Sensor (3) kit for the following packaging: GS3 SEMI 5PK OUS/ GTIN: 20763000192086, 5PK SF NEW G...
Diabetes Devices·497,747 affected·Feb 26, 2021
High RiskFDA
Medtronic Inc.
Medtronic REF: MMT-7020B, Guardian Sensor (3) for the following packaging: GS3 1PK 2L US/GTIN: 00763000140779 GS3 1PK 2L US/ GTIN...
Diabetes Devices·302,667 affected·Feb 26, 2021
High RiskFDA
Medtronic Inc.
Medtronic REF: MMT-7020D2 Guardian Sensor (3) for the following packaging: GS3 1PK 9L OUS2/ GTIN: 00763000243357 GS3 1PK 9L OUS2/ G...
Diabetes Devices·15,162 affected·Feb 26, 2021
High RiskFDA
Medtronic Inc.
Medtronic REF: MMT-7020C3 Guardian Sensor (3) for the following packaging: GS3 5PK OUS3/ GTIN: 20643169704118 GS3 5PK 9L OUS3/ GTI...
Diabetes Devices·15,393 affected·Feb 26, 2021
High RiskFDA
Medtronic Inc.
Medtronic REF: MMT-7020A, Guardian Sensor (3) for the following packaging: GS3 5PK 2L US/ GTIN: 20763000140940 GS3 5PK 2L US/ GTIN:...
Diabetes Devices·1,224,032 affected·Feb 26, 2021
High RiskFDA
Medtronic Inc.
Medtronic REF: MMT-7020D1 Guardian Sensor (3) for the following packaging: GS3 1PK OUS1/ GTIN: 00643169704084 GS3 1PK 9L OUS1/ GTIN...
Diabetes Devices·111,678 affected·Feb 26, 2021
High RiskFDA
Medtronic Inc.
Medtronic REF: MMT-7020D3 Guardian Sensor (3) for the following packaging: GS3 1 PK OUS3/ GTIN: 00643169704121 GS3 1PK 9L OUS3/ GTI...
Diabetes Devices·13,014 affected·Feb 26, 2021
High RiskFDA
Medtronic Inc.
Medtronic, REF: MMT-7008C, Enlite Glucose Sensor for the following packaging: ENLITE AUS 1 PRESS 5PK/ GTIN: 20763000252032 Product Us...
Diabetes Devices·1,174 affected·Feb 26, 2021
High RiskFDA
Medtronic Inc.
Medtronic REF: MMT-7020D4 Guardian Sensor (3) for the following packaging: GS3 1PK 2L CANADA/ GTIN: 00763000179595¿ Product Usage: ...
Diabetes Devices·12,624 affected·Feb 26, 2021
High RiskFDA
Medtronic Inc.
Medtronic REF: MMT-7020GA, Guardian Sensor (3) for the following packaging: GS3 5PK US GC/ GTIN: 20763000179629 Product Usage: inte...
Diabetes Devices·1,863 affected·Feb 26, 2021
High RiskFDA
Medtronic Inc.
Medtronic REF: MMT-7020LB, Guardian Sensor (3) for the following packaging: GS3 1PK US/ GTIN: 763000336998 Product Usage: intended ...
Diabetes Devices·5,571 affected·Feb 26, 2021