Category

Diabetes Devices Recalls

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

295 recalls
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products GLU Slides, REF/Product Code 170 7801 (300 slides per sales unit), Unique Device Identifier No. 10758750009572...
Diabetes Devices·192,459 affected·Aug 11, 2016
High RiskFDA
Medtronic Inc.
CareLink iPro Version 1.10, Catalog No. MMT-7340 With data obtained from the iPro2 recorder and blood glucose meter, the CareLink iPro s...
Diabetes Devices·33 affected·Aug 5, 2016
High RiskFDA
Roche Diagnostics Operations, Inc.
cobas p 701 Post-Analytical Unit calculator/data processing module, for clinical use Product Usage: The URISYS 2400 Analyzer is a fu...
Diabetes Devices·9,014 affected·Jul 15, 2016
High RiskFDA
Trividia Health
TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult and TRUE2go meters. TRUEread Blood Glucose Test Strips are ...
Diabetes Devices·5,527,921 affected·Jun 28, 2016
High RiskFDA
Trividia Health
TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult and TRUE2go meters. TRUEread Blood Glucose Test Strips are ...
Diabetes Devices·5,527,921 affected·Jun 28, 2016
High RiskFDA
Trividia Health
TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult and TRUE2go meters. TRUEread Blood Glucose Test Strips are ...
Diabetes Devices·5,527,921 affected·Jun 28, 2016
High RiskFDA
Greiner Bio-one North America, Inc.
4 ml FX Sodium Fluoride/Potassium Oxalate tube, Ref 454297 VACUETTE Glycolytic Inhibitor Tubes contain an antiglycolytic agent, sodium f...
Diabetes Devices·250,800 affected·Apr 26, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA Chemistry Glucose & Concentrated Glucose Oxidase Assay and ADVIA Chemistry Glucose.
Diabetes Devices·137,422 affected·Mar 17, 2016
CriticalFDA
Dexcom Inc
Dexcom G4 PLATINUM (Professional) Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black. Intended to detect trends and track g...
Diabetes Devices·5,722 affected·Feb 23, 2016
CriticalFDA
Dexcom Inc
Dexcom G4 PLATINUM (Pediatric) Receiver Receiver Part Number: MT22430 Receiver (mg/dL), Black (pediatrics); MT22430-PNK, Receiver (mg/dL...
Diabetes Devices·18,004 affected·Feb 23, 2016
CriticalFDA
Dexcom Inc
Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649-PNK, Receiver (mg/dL), Pink; MT20649-BLU, Rec...
Diabetes Devices·131,768 affected·Feb 23, 2016
CriticalFDA
Dexcom Inc
Dexcom G5 Mobile Receiver Receiver Part Number: MT22719 Receiver (mg/dL), Black; MT22719-PNK, Receiver (mg/dL), Pink; MT22719-BLU, Rece...
Diabetes Devices·41,925 affected·Feb 23, 2016
CriticalFDA
Dexcom Inc
Dexcom G4 PLATINUM (Pediatric) Receiver with Share Receiver Part Number: MT22608 Receiver (mg/dL), Black (pediatrics); MT22608-PNK, Rece...
Diabetes Devices·19,586 affected·Feb 23, 2016
High RiskFDA
Medtronic Minimed Inc.
CareLink iPro2 Reports, Model No. MMT-7340 is software intended to retrospectively calibrates sensor data and provides reports of contin...
Diabetes Devices·20 affected·Feb 19, 2016
High RiskFDA
Roche Diagnostics Operations, Inc.
Accu-Chek Inform II Base Unit as a part of the Accu-Chek Inform II Blood Glucose Monitoring System Accu-Chek inform II Blood Glucose Mon...
Diabetes Devices·5,604 affected·Feb 11, 2016
High RiskFDA
Horiba Instruments Inc
ABX PENTRA Glucose PAP CP ref. A11A01668 reagent is intended for the quantitative in vitro diagnostic determination of glucose in human ...
Diabetes Devices·216 affected·Jan 11, 2016
CriticalFDA
Arkray Factory Usa, Inc.
arkray SPOTCHEM II Basic Panel - 1 Reagent test strips, Product # 11726, MEDTEST DX Catalog # 77484. Calcium, Blood Urea Nitrogen, Gluco...
Diabetes Devices·11 affected·Dec 18, 2015
CriticalFDA
Arkray Factory Usa, Inc.
arkray SPOTCHEM II Glucose Reagent test strips, Item No. 77101, MEDTEST DX Catalog # 77424. For the in vitro quantitative determinat...
Diabetes Devices·88 affected·Dec 18, 2015
CriticalFDA
Insulet Corporation
OmniPod¿, Insulin Management System (OUS) Catalog Number: 14810 Product Usage: The OmnniPod¿ Insulin Management System is intended ...
Diabetes Devices·5,179 affected·Nov 2, 2015
CriticalFDA
Insulet Corporation
OmniPod¿, Insulin Management System (US) Catalog Number: PODZXP420 Product Usage: The OmnniPod¿ Insulin Management System is intende...
Diabetes Devices·26,230 affected·Nov 2, 2015
High RiskFDA
Medtronic Minimed Inc.
MiniMed 640G, 3.0mL mmol/L, 3.0mL mg/dL, Model No. MMT-1711 and MMT-1712 The MiniMed 620G and MiniMed 640G insulin pump systems are in...
Diabetes Devices·1,052 affected·Sep 25, 2015
High RiskFDA
Medtronic Minimed Inc.
MiniMed 620G, 3.0mL mg/dL, Model No. MMT-1710 The MiniMed 620G and MiniMed 640G insulin pump systems are indicated for the continuous ...
Diabetes Devices·53 affected·Sep 25, 2015
High RiskFDA
Elitech Clinical Systems Sas
ELITech Clinical Systems reagents used on the Selectra ProS and ProM systems that utilize the Trinder Reaction method. The following p...
Diabetes Devices·969 affected·Sep 22, 2015
High RiskFDA
Elitech Clinical Systems Sas
Eon 100 system included the following product reference numbers and names: Reference no. 77345- Glucose (GPSL) Reference no. 77450- ...
Diabetes Devices·1,389 affected·Sep 22, 2015
High RiskFDA
Elitech Clinical Systems Sas
Envoy 500 system includes the following product reference numbers and names: 55345 ENVOY 500 Glucose 55450 ENVOY 500 URIC ACID REAGE...
Diabetes Devices·13,455 affected·Sep 22, 2015
High RiskFDA
Elitech Clinical Systems Sas
Eon 300 system includes the following product reference numbers and names: Reference no. 79345 Glucose (GPSL) Reference no. 79450 Uri...
Diabetes Devices·612 affected·Sep 22, 2015
RecallFDA
Alere San Diego, Inc.
Alere Cholestech LDX Multianalyte Controls, PN 88769 and 88773. Enables users to monitor the performance of total cholesterol (TC), h...
Diabetes Devices·190 affected·Aug 27, 2015
High RiskFDA
Siemens Healthcare Diagnostics Inc
Siemens RAPIDPoint 500 Measurement Cartridge Lactate (750 tests) Part Number: 10491449 Product Usage: The RAPIDPoint 500 system is d...
Diabetes Devices·2,079 affected·Aug 24, 2015
High RiskFDA
Siemens Healthcare Diagnostics Inc
Siemens RAPIDPoint 500 Measurement Cartridge Lactate (100) tests Part Number: 10844813 Product Usage: The RAPIDPoint 500 system is d...
Diabetes Devices·49 affected·Aug 24, 2015
High RiskFDA
Medtronic Minimed Inc.
Guardian Real-Time Monitor, Model No. CSS7100. Indicated for continuous or periodic monitoring of glucose levels in the fluid under the ...
Diabetes Devices·254 affected·Jul 22, 2015
CriticalFDA
Insulet Corporation
OmniPod¿ Insulin Management System. Only the OmniPod¿ device is affected. Catalog Number(s): 14810 (OUS). Intended for subcutaneous del...
Diabetes Devices·16,017 affected·Jul 13, 2015
CriticalFDA
Insulet Corporation
OmniPod¿ Insulin Management System. Only the OmniPod¿ device is affected. Catalog Number(s): POD-ZXP420 (US). Intended for subcutaneous ...
Diabetes Devices·24,829 affected·Jul 13, 2015
High RiskFDA
Roche Diagnostics Operations, Inc.
S2 Fluid Pack on the Cobas b 221 system- Catalog Number 03260925184 Blood Gas and Electrolytes Analyzer; The Roche Diagnostics Omni S ...
Diabetes Devices·19 affected·Jun 24, 2015
High RiskFDA
Pointe Scientific, Inc.
Pointe Scientific G6PD Controls Kit configuration: 6 x 0.5 ml (2 vials each of Level 1, Level 2 and Level 3). Also sold as individual ...
Diabetes Devices·2,772 affected·May 19, 2015
High RiskFDA
The Binding Site Group, Ltd.
Optilite Analyser, Product Code: IE700 Product Usage: The Thermo Scientific Indiko Clinical Chemistry Analyzer is a fully automated r...
Diabetes Devices·129 affected·May 13, 2015
High RiskFDA
Roche Diabetes Care, Inc.
AccuChek Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System.
Diabetes Devices·35,795 affected·Apr 22, 2015
High RiskFDA
Roche Diabetes Care, Inc.
AccuChek Spirit insulin infusion pump.
Diabetes Devices·35,795 affected·Apr 22, 2015
High RiskFDA
Siemens Healthcare Diagnostics Inc
RAPIDPoint 500 Blood Gas Analyzer; Siemens Material Number: 10492730, 10696855, 10696857, 10697306. The RAPIDPoint 500 system is desi...
Diabetes Devices·4,376 affected·Dec 30, 2014
High RiskFDA
Siemens Healthcare Diagnostics Inc
RAPIDLab 1265 System; Siemens Material Number: 10491395, 10321852, 10335524. The Rapidlab 1200 systems are intended for in vitro diag...
Diabetes Devices·2,863 affected·Dec 30, 2014
High RiskFDA
Siemens Healthcare Diagnostics Inc
RAPIDLab 1245 System; Siemens Material Number: 10321844, 10491393, 10337179. The Rapidlab 1200 systems are intended for in vitro diag...
Diabetes Devices·241 affected·Dec 30, 2014
High RiskFDA
Owen Mumford Usa, Inc.
Autopen Classic Automatic insulin delivery pen, 3.0ml x 2 unit 2-42 units, AN3800, Lot 7JH, NDC 08470-3800-01, The product is a non-st...
Diabetes Devices·225 affected·Dec 11, 2014
RecallFDA
Medtronic Minimed Inc.
CareLink Pro Medtronic CareLink Pro MMT-7335 is a personal computer software application designed to enhance Health Care Provider manage...
Diabetes Devices·5 affected·Nov 10, 2014
High RiskFDA
Unomedical As
Comfort 5+5 Pack w/110cm Tube & 17mm Cann. UPC# 3-89110-14147-7; Comfort 5+5 Pack w/60cm Tube & 17mm Cann. UPC# 3-89110-14127-9; Comfort ...
Diabetes Devices·22,114 affected·Nov 7, 2014
High RiskFDA
Unomedical As
AC TenderLink 13/30 10 pcs; AC TenderLink I 13/60 10 pcs; AC TenderLink I 13/80 10 pcs; AC TenderLink I 17/110 10 pcs; AC TenderLink I 17...
Diabetes Devices·653,280 affected·Nov 7, 2014
High RiskFDA
Unomedical As
Contact Detach, 8mm, 23", G29; Contact Detach 8 mm, 43", G29; Contact Detach, 6mm, 23" G29; Infusion Set, Contact Detach, 6mm x 23"; Infu...
Diabetes Devices·664,000 affected·Nov 7, 2014
High RiskFDA
Unomedical As
SureT G29 6mm, 18", Paradigm; SureT G29 6mm 23"; SureT G29 6mm, 23", Paradigm; SureT G29 6mm 32"' SureT G29 6mm, 32", Paradigm; SureT G29...
Diabetes Devices·4,748,000 affected·Nov 7, 2014
High RiskFDA
Unomedical As
Silhouette Paradigm 13mm, 18"; Silhouette 43"; Silhouette 23"; Silhouette Paradigm 43"; Silhouette Paradigm 23"; Silhouette Paradigm 13mm...
Diabetes Devices·9,782,880 affected·Nov 7, 2014
High RiskFDA
Medtronic Minimed Inc.
Medtronic MiniMed Silhouette and/or MiniMed Sure-T Infusion Sets; Paradigm Silhouette infusion sets: MMT-368, MMT-368600, MMT-371, MMT-37...
Diabetes Devices·12,400,098 affected·Nov 4, 2014