Category

Diabetes Devices Recalls

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

295 recalls
High RiskFDA
Medtronic Inc.
Medtronic REF: MMT-7020C4 Guardian Sensor (3) for the following packaging: GS3 5PK 2L CANADA/ GTIN: 20763000179612 Product Usage: ...
Diabetes Devices·54,211 affected·Feb 26, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista HDLC - colorimetric method, lipoproteins - Product Usage: used as an aid in the diagnosis of lipid disorders (such as dia...
Diabetes Devices·4,174 affected·Feb 3, 2021
High RiskFDA
Insulet Corporation
Omnipod DASH Insulin Management System User Guide (OUS Only) Product Catalog Number: PT 000002 XXX XXX XX PT 000318 PT 000319 Di...
Diabetes Devices·21,723 affected·Feb 1, 2021
High RiskFDA
Abbott Point Of Care Inc.
Abbott i-STAT CG8+ cartridges - IVD Intended for quantitative measurement of sodium, potassium, ionized calcium, glucose, pH, pCO2, pO2 a...
Diabetes Devices·2,820,000 affected·Dec 22, 2020
High RiskFDA
Medtronic Inc.
CareLink Personal Software Therapy Management Software Tool for Diabetes CareLink System Therapy Management Software Tool for Diabetes ...
Diabetes Devices·46,461 affected·Nov 12, 2020
High RiskFDA
Tandem Diabetes Care Inc
t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM, and t:slim X2 Insulin Pump with Basal-IQ Technology
Diabetes Devices·5,206 affected·Sep 10, 2020
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry Fructosamine Reagent (FRUC), Siemens Material Number 10361941, UDI Number 00630414558073 - Product Usage: use in the quan...
Diabetes Devices·5 affected·May 4, 2020
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH Fructosamine Reagent (FRUC), Siemens Material Number 11097637, UDI Number 00630414595580 use in the quantitative measurement ...
Diabetes Devices·26 affected·May 4, 2020
High RiskFDA
Medtronic Inc.
MiniMed 670G, insulin pump, Ref/Model # MMT-1760KPK, MMT-1762KCN, MMT-1762WWK - Product Usage: indicated for continuous or periodic monit...
Diabetes Devices·391 affected·Apr 30, 2020
High RiskFDA
Trividia Health, Inc.
TRUE METRIX SELF MONITORING BLOOD GLUCOSE SYSTEM - Product Usage: is intended for the quantitative measurement of glucose (sugar) in fres...
Diabetes Devices·1 affected·Apr 20, 2020
RecallFDA
Abbott Laboratories
ARCHITECT C Peptide Calibrator - Product Usage: used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion...
Diabetes Devices·65 affected·Apr 1, 2020
RecallFDA
Abbott Laboratories
ARCHITECT C Peptide Reagent - Product Usage: used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion in...
Diabetes Devices·65 affected·Apr 1, 2020
High RiskFDA
Insulet Corporation
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...
Diabetes Devices·32,756 affected·Feb 13, 2020
High RiskFDA
Dexcom Inc
Dexcom G6 Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monitoring dev...
Diabetes Devices·275,583 affected·Feb 3, 2020
High RiskFDA
Dexcom Inc
Dexcom G4 PLATINUM Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monit...
Diabetes Devices·3,091 affected·Feb 3, 2020
High RiskFDA
Dexcom Inc
Dexcom G5 Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monitoring dev...
Diabetes Devices·85,529 affected·Feb 3, 2020
High RiskFDA
Abbott Point Of Care Inc.
i-STAT CHEM8+ cartridges (blue), List No. 09P31-25. UDI (01) 00054749001910 - Product Usage: The i-STAT CHEM8+ cartridge may be used for ...
Diabetes Devices·9,049,725 affected·Jan 15, 2020
High RiskFDA
Roche Diabetes Care, Inc.
Accu-Chek Aviva Plus Health Network Strips- intended for Blood Glucose Monitoring System Catalog Number: 06908349001
Diabetes Devices·82,332 affected·Dec 11, 2019
High RiskFDA
Roche Diabetes Care, Inc.
Accu-Chek Aviva Plus Retail Strips 50 ct - intended for Blood Glucose Monitoring System Catalog Number: 06908217001
Diabetes Devices·92,836 affected·Dec 11, 2019
CriticalFDA
Medtronic Inc.
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 ...
Diabetes Devices·0 affected·Nov 21, 2019
CriticalFDA
Medtronic Inc.
Medtronic MiniMed 620G Insulin Infusion Pump, Ref #s/Model(s) - MMT-1510, MMT-1710, and MMT-1750 *Not Distributed within the US
Diabetes Devices·0 affected·Nov 21, 2019
High RiskFDA
Abbott Diabetes Care, Inc.
Precision Xtra Blood Glucose & Ketone Monitoring System, UDI: 00093815715023, 00093815988144
Diabetes Devices·0 affected·Nov 14, 2019
High RiskFDA
Abbott Diabetes Care, Inc.
Optium EZ Blood Glucose Monitoring System, UDI: 00093815710653
Diabetes Devices·0 affected·Nov 14, 2019
High RiskFDA
Roche Diabetes Care, Inc.
Blood Glucose Monitoring System, Model Number 08453063001 ACCU-CHEK GUIDE SAMPLE KIT FCN MG/DL US - Product Usage: The Accu-Chek Guide B...
Diabetes Devices·355,400 affected·Sep 30, 2019
High RiskFDA
Roche Diabetes Care, Inc.
Blood Glucose Monitoring System, Model Number 08313202001 ACCU CHEK GUIDE HCP SAMPLE LAUNCH BOX - Product Usage: The Accu-Chek Guide Blo...
Diabetes Devices·452,392 affected·Sep 30, 2019
High RiskFDA
Medline Industries Inc
EVENCARE G3 Blood Glucose Test Strips, 1 test strip per foil pouch, 50 foil pouches per box, 12 boxes per case.
Diabetes Devices·761 affected·Sep 18, 2019
High RiskFDA
Labstyle Innovations
Dario Blood Glucose Monitoring System, Model No. 1015-05, running Android software versions 4.3.0-4.3.2
Diabetes Devices·126,271 affected·Aug 29, 2019
High RiskFDA
Medtronic Minimed
Medtronic MiniMed Paradigm Insulin pump, model number MMT-723
Diabetes Devices·72,850 affected·Jun 27, 2019
High RiskFDA
Medtronic Minimed
Medtronic MiniMed Paradigm Insulin pump, model number MMT-523K
Diabetes Devices·27 affected·Jun 27, 2019
High RiskFDA
Medtronic Minimed
Medtronic MiniMed Paradigm Insulin pump, model numbers MMT 515 and MMT-715
Diabetes Devices·73,028 affected·Jun 27, 2019
High RiskFDA
Medtronic Minimed
MiniMed Insulin Pump, model # MMT-508
Diabetes Devices·64,174 affected·Jun 27, 2019
High RiskFDA
Medtronic Minimed
Medtronic MiniMed Paradigm Insulin pump, model number MMT-522
Diabetes Devices·88,243 affected·Jun 27, 2019
High RiskFDA
Medtronic Minimed
Medtronic MiniMed Paradigm Veo Insulin pump, model numbers MMT-554 and MMT-754
Diabetes Devices·68,598 affected·Jun 27, 2019
High RiskFDA
Medtronic Minimed
MiniMed Paradigm 512 Insulin pump
Diabetes Devices·34,777 affected·Jun 27, 2019
High RiskFDA
Medtronic Minimed
MiniMed Paradigm Insulin pump, model number MMT-712
Diabetes Devices·74,496 affected·Jun 27, 2019
High RiskFDA
Medtronic Minimed
Medtronic MiniMed Paradigm Insulin pump, model number MMT-712E
Diabetes Devices·36,143 affected·Jun 27, 2019
High RiskFDA
Medtronic Minimed
MiniMed Paradigm Model 511 Insulin Pump
Diabetes Devices·30,479 affected·Jun 27, 2019
High RiskFDA
Medtronic Minimed
Medtronic MiniMed Paradigm Insulin pump, model number MMT-722
Diabetes Devices·225,498 affected·Jun 27, 2019
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products GLU Slides-Product Code:1707801. IVD VITROS Chemistry Products GLU Slides quantitatively measure glucose (GL...
Diabetes Devices·1,099 affected·Jun 17, 2019
High RiskFDA
Roche Diabetes Care, Inc.
Accu-Chek Connect Diabetes Management App
Diabetes Devices·0 affected·May 3, 2019
High RiskFDA
Randox Laboratories Ltd.
G-6-PDH Normal Control (G-6-PDH CONTROL N), Catalogue Number PD2618 Product Usage: This product is intended for in vitro diagnostic u...
Diabetes Devices·10 affected·Apr 3, 2019
High RiskFDA
Alere San Diego, Inc.
Alere Cholestech LDX Analyzer, model # 14-874 containing power supplies with the identifying codes of 1837d and 1843d - Product Usage: Th...
Diabetes Devices·186 affected·Feb 15, 2019
High RiskFDA
Insulet Corporation
Omnipod DASH Insulin Management System, Product Catalog Number 18239 M/D: PDM USA1 D001 MG USA1
Diabetes Devices·264 affected·Dec 18, 2018
High RiskFDA
Voluntis
Insulia Diabetes Management Companion
Diabetes Devices·14 affected·Oct 8, 2018
High RiskFDA
Roche Diagnostics Corporation
Roche Diagnostics URISYS 1100 Urine Analyzer Part Number: 03617556001 Product Usage: The URISYS 1100 Urine Analyzer is a reflectance...
Diabetes Devices·14,398 affected·Sep 24, 2018
High RiskFDA
Cypress Medical Products Llc
McKesson Insulin Syringe 0.3mL 31GX5/16 Item Numbers: 102-SN310C31516P Product Usage: Indication of Use: Injection of U-100 insulin...
Diabetes Devices·400 affected·Sep 4, 2018
High RiskFDA
Shinchang Medical Co., Ltd.
Disposable Insulin Syringe 0.3mL in 3 different sizes 29Gx1/2, 30Gx5/16, and 31G x 5/16. (10 syringes are packaged in a flexible plasti...
Diabetes Devices·6,570,800 affected·Aug 24, 2018
High RiskFDA
Cambridge Sensors Limited
Microdot Xtra blood glucose test strips
Diabetes Devices·17,784 affected·Jul 26, 2018