Category

Diabetes Devices Recalls

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

295 recalls
High RiskFDA
Jas Diagnostics Inc.
Glucose Hexokinase (Liquid) Reagent For the in vitro quantitative determination of Glucose in serum.
Diabetes Devices·390 affected·Oct 23, 2014
High RiskFDA
Radiometer America Inc
HemoCue¿ Glucose 201 Microcuvettes, The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201Analyzer and t...
Diabetes Devices·3,712,900 affected·Oct 20, 2014
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Siemens Dimension HB1C Flex reagent cartridge; Dimension Hemoglobin A1c (HB1C) Flex reagent cartridge on the Dimension clinical chemistry...
Diabetes Devices·53 affected·Sep 30, 2014
High RiskFDA
Roche Diagnostics Operations, Inc.
ACCU-CHEK Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System Product Usage: The ACCU-CHEK Combo System is mean...
Diabetes Devices·8,116 affected·Sep 25, 2014
RecallFDA
Roche Diagnostics Operations, Inc.
Omni Micro-electrode/reference electrode for cobas b221 analyzer. The Roche Diagnostics Omni S Analyzer is a fully automated critical ...
Diabetes Devices·492 affected·Sep 12, 2014
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Siemens Dimension Vista¿ CHEM 1 CAL, lot 3GM081. The CHEM 1 CAL is an in vitro diagnostic product for the calibration of Calcium (CA),...
Diabetes Devices·9,769 affected·Aug 18, 2014
High RiskFDA
Medtronic Minimed Inc.
Medtronic MiniMed Guardian Monitor, Model No. CSS7100, CSS7100K Product Usage: The Medtronic MiniMed model CSS7100 and CSS7100K Guard...
Diabetes Devices·86 affected·Jul 21, 2014
High RiskFDA
Animas Corporation
Animas Vibe Insulin Infusion Pump. This product is indicated for continuous subcutaneous infusion of insulin for the treatment of diab...
Diabetes Devices·1,028 affected·Jun 10, 2014
RecallFDA
Becton Dickinson & Co.
BBL CrystaLEAD Enteric/Nonfermentor (E/NF) Identification (ID) System, catalog number 245000. in vitro diagnostic for the identificatio...
Diabetes Devices·18 affected·May 21, 2014
High RiskFDA
Nxstage Medical, Inc.
NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-302 Lactate , 40, Potassium 1, Sodium 140, Calcium 3, ...
Diabetes Devices·19,423 affected·May 14, 2014
High RiskFDA
Nxstage Medical, Inc.
NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-305 Lactate 45, Potassium 1, Sodium 140, Calcium 3, Ma...
Diabetes Devices·2,839 affected·May 14, 2014
High RiskFDA
Nxstage Medical, Inc.
NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-304 Lactate 45, Potassium 2, Sodium 140, Calcium 3,Mag...
Diabetes Devices·16,625 affected·May 14, 2014
High RiskFDA
Roche Diagnostics Operations, Inc.
ACCU-CHEK Compact Plus Test Strips For use with: ACCU-CHEK Compact Plus Meters; 17 count sample strip 51 count retail strip; 102 count ...
Diabetes Devices·590,136 affected·Apr 14, 2014
High RiskFDA
Jas Diagnostics Inc.
Glucose Hexokinase Liquid Reagent For the in vitro quantitative determination of Glucose in serum.
Diabetes Devices·407 affected·Apr 7, 2014
High RiskFDA
Roche Diagnostics Operations, Inc.
Omni Micro-electrode/reference electrode for cobas b221 analyzer, Model/Catalog/Part Number: 03111873180 as a part of the following sys...
Diabetes Devices·0 affected·Feb 28, 2014
CriticalFDA
Abbott Diabetes Care, Inc.
FreeStyle Blood Glucose Monitors System. For in vitro diagnostic use only. Store at room temperature below 86 degrees F (30 degrees C)....
Diabetes Devices·5 affected·Feb 19, 2014
High RiskFDA
Perrigo Diabetes Care
Orbit soft Infusion sets, 9 mm soft cannula, P10 (42") tubing; Single-Use Set Orbit Infusion Sets are sterile, non-pyrogenic, single-use...
Diabetes Devices·7,924 affected·Dec 20, 2013
CriticalFDA
Abbott Diabetes Care, Inc.
FreeStyle Blood Glucose Test Strips; For in vitro diagnostic testing. 50 count UPC 6 99073 12050 2; Freestyle Blood Glucose Test Stri...
Diabetes Devices·141,219 affected·Nov 18, 2013
CriticalFDA
Abbott Diabetes Care, Inc.
FreeStyle Lite Blood Glucose Test Strips; For in vitro diagnostic testing. 50 count; 100 count Product of Ireland; UPC 6 99073 7081...
Diabetes Devices·141,219 affected·Nov 18, 2013
High RiskFDA
Nova Biomedical Corporation
Nova StatStrip/StatSensor Hospital Blood Glucose Meter; Nova StatStrip Lactate Hospital Meter System; Nova StatSensor Creatinine Hospital...
Diabetes Devices·200,000 affected·Oct 10, 2013
High RiskFDA
Nipro Diagnostics, Inc.
MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for Self-Testing & Multi-Patient Use TRUEtrack. Manufactured by:...
Diabetes Devices·105 affected·Oct 2, 2013
High RiskFDA
Roche Diagnostics Operations, Inc.
ACCU-CHECK FastClix Lancing Device. It is intended for use in conjunction with a blood glucose monitoring system.
Diabetes Devices·36,332 affected·Aug 19, 2013
CriticalFDA
Nova Biomedical Corporation
Nova Max Glucose Test Strips (100 Count Retail Canada)Catalog Number: 43955 Product Usage: The Nova Max Glucose Test Strips are for...
Diabetes Devices·1,564,500 affected·Jul 15, 2013
CriticalFDA
Nova Biomedical Corporation
Nova Max Glucose Test Strips (50 Count International Catalog Number: 45512 Product usage: The Nova Max Glucose Test Strips are for u...
Diabetes Devices·366,140 affected·Jul 15, 2013
CriticalFDA
Nova Biomedical Corporation
Nova Max Glucose Test Strips (10 Count Canada)Catalog Number: 43877 Product The Nova Max Glucose Test Strips are for use with the Nova...
Diabetes Devices·9,200 affected·Jul 15, 2013
CriticalFDA
Nova Biomedical Corporation
Nova Max Plus Monitor System (Kit w/10 Count Vials International) Catalog Number: 45507 Product Usage: The Nova Max Glucose Test Str...
Diabetes Devices·13,600 affected·Jul 15, 2013
CriticalFDA
Nova Biomedical Corporation
Nova Max Glucose Test Strips (10 Count Vials) Catalog Number: 43604 These strips are kitted into Nova Max Glucose Test Strip System Kit...
Diabetes Devices·43,435 affected·Jul 15, 2013
High RiskFDA
Smiths Medical Asd, Inc.
Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 0.5ml 29g x 1/2 in Reference: 4429-5 Hypodermic Needle-Pro...
Diabetes Devices·506,925 affected·Jul 10, 2013
CriticalFDA
Medtronic Minimed
Medtronic MiniMed Paradigm Insulin Infusion Sets The Paradigm infusion sets are intended for use with Paradigm insulin infusion pumps.
Diabetes Devices·11,000,000 affected·Jun 7, 2013
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
HbA1c Flex(R) reagent cartridge (K3105A, Siemens Material Number 10470481) for the Dimension(R) Clinical Systems. Dimension(R) Hemoglo...
Diabetes Devices·11,006 affected·Apr 22, 2013
CriticalFDA
Abbott Diabetes Care, Inc.
FreeStyle InsuLinx Blood Glucose Monitoring System: For In Vitro Diagnostic Use only. Use only with FreeStyle InsuLinx test strips. A...
Diabetes Devices·335,273 affected·Apr 15, 2013
High RiskFDA
Medtronic Minimed
Medtronic MiniMed Paradigm Insulin Infusion Pumps Model Numbers: MMT-511, MMT-512, MMT-712, MMT-712E, MMT-515, MMT-715, MMT-522, MMT-5...
Diabetes Devices·428,000 affected·Mar 22, 2013
CriticalFDA
Lifescan Inc
All OneTouch Verio IQ Blood Glucose Meters sold as: Verio IQ System Kits - Meter; Verio IQ Starter kits - Meter; Verio IQ Warranty Met...
Diabetes Devices·710,413 affected·Mar 11, 2013
High RiskFDA
Roche Diagnostics Operations, Inc.
ACCU-CHEK Inform II Blood Glucose Monitoring System bar code scanner. Used with the ACCU-CHEK Inform II System to quantitatively meas...
Diabetes Devices·4,467 affected·Mar 6, 2013
High RiskFDA
Lifescan Inc
LifeScan brand OneTouch¿ Select Control Solution, Part Number/Model #: 02168902. Testing of Blood Glucose Levels.
Diabetes Devices·132,301 affected·Feb 25, 2013
High RiskFDA
Nipro Diagnostics, Inc.
Duane Reade TRUEtrack monitor kit, UPC# 6 39194 01679 7 Part # A4006-81 The TRUEtrack Blood Glucose System is intended for the quantit...
Diabetes Devices·1,627 affected·Feb 25, 2013
CriticalFDA
Animas Corporation
Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the...
Diabetes Devices·7,157 affected·Jan 3, 2013
High RiskFDA
Beckman Coulter Inc.
Beckman Coulter AU5800 Clinical Chemistry Analyzer. An automated chemistry analyzer that measures analytes such as Glucose, Magnesium, an...
Diabetes Devices·28 affected·Nov 28, 2012
RecallFDA
Siemens Healthcare Diagnostics Inc
Siemens Chek-Stix Positive and Negative Control Strips for Urine Chemistry Catalog Number:1360 Chek-Stix¿ Positive and Negative Contr...
Diabetes Devices·7,865 affected·Nov 21, 2012
RecallFDA
Siemens Healthcare Diagnostics Inc
Siemens Chek-Stix Combo Pak (Distributed OUS only) Catalog Number: 1364M Chek-Stix¿ Positive and Negative Control Strips for Urine Ch...
Diabetes Devices·325 affected·Nov 21, 2012
RecallFDA
Siemens Healthcare Diagnostics Inc
Siemens Chek-Stix Positive and Negative Control Strips for Urine Chemistry (Distributed OUS Only) Catalog Number: 1360L Chek-Stix¿ P...
Diabetes Devices·700 affected·Nov 21, 2012
High RiskFDA
Siemens Healthcare Diagnostics Inc
Siemens Chek-Stix Combo Pak (Distributed OUS only) Catalog Number: 1364N Chek-Stix¿ Positive and Negative Control Strips for Urine ...
Diabetes Devices·1,130 affected·Nov 21, 2012
RecallFDA
Siemens Healthcare Diagnostics Inc
Siemens Chek-Stix Combo Pak Catalog Number: 1364 Chek-Stix¿ Positive and Negative Control Strips for Urine Chemistry: When used with...
Diabetes Devices·16,711 affected·Nov 21, 2012
High RiskFDA
Animas Corporation
Animas Vibe Insulin Infusion Pump and System. These products are indicated for continuous subcutaneous infusion of insulin for the tre...
Diabetes Devices·1,938 affected·Oct 25, 2012
RecallFDA
Alere San Diego, Inc.
Alere Cholestech LDX Calibration Verification, 4 vial set, Catalog Number: 88770 Alere Cholestech LDX Calibration Verification (hereaf...
Diabetes Devices·614 affected·Oct 22, 2012
High RiskFDA
Sanofi-aventis Us, Inc.
Diamigo i-Phone App The Diamigo app was intended for use as an educational tool in the management of diabetes.
Diabetes Devices·1,600 affected·Sep 21, 2012
High RiskFDA
Siemens Healthcare Diagnostics Inc
Siemens RAPIDLab¿ 1265 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for i...
Diabetes Devices·2,939 affected·Sep 17, 2012
High RiskFDA
Siemens Healthcare Diagnostics Inc
Siemens RAPIDPoint¿¿ 405 system blood gas analyzer Product PUsage: These systems are intended for near-patient and laboratory testing...
Diabetes Devices·4,494 affected·Sep 17, 2012