Category

Diabetes Devices Recalls

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

295 recalls
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
RAPIDLab 1265 Blood Gas Analyzer; 110321852, 10470366, 10491395 Device is point-of-care system for comprehensive lab-quality testing ...
Diabetes Devices·2,357 affected·Jul 16, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
RAPIDLab 1245 Blood Gas Analyzer; 10321844, 10337179, 10491393 Device is point-of-care system for comprehensive lab-quality testing t...
Diabetes Devices·138 affected·Jul 16, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
RAPIDPoint 500 Blood Gas Analyzer; 10492730, 1069855, 10696857, 10697306 Device is point-of-care system for comprehensive lab-quality...
Diabetes Devices·10,199 affected·Jul 16, 2018
High RiskFDA
Tosoh Bioscience Inc
G8 Automated HPLC Analyzer - 723G8 Product Usage - In vitro diagnostic use for the quantitative measurement of % hemoglobin A1c in who...
Diabetes Devices·8 affected·Jul 13, 2018
RecallFDA
Clarity Diagnostics Llc
Clarity Urocheck 10SG Urinalysis Strips, Model # DTG-10SG Product Usage: Clarity 10SG Urinalysis Reagent Strips (Urine) are for the q...
Diabetes Devices·7,536 affected·Jun 22, 2018
High RiskFDA
Medtronic Inc.
Contour Plus Link 2.4, Product Catalog Number: MMT-1151SK. wireless blood glucose monitoring system Contour Plus LINK 2.4 wireless bl...
Diabetes Devices·2 affected·May 16, 2018
High RiskFDA
Life Technologies, Corp.
Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, Model Number 11965175. Tissue and cell culture medium.
Diabetes Devices·91 affected·May 10, 2018
High RiskFDA
Roche Diabetes Care, Inc.
Accu-Chek Performa Test Strip, Blood glucose monitoring system, Catalog no. 07299702001 Product Usage: The Accu-Chek Performa test st...
Diabetes Devices·295,248 affected·May 7, 2018
High RiskFDA
Medtronic Inc.
Medtronic MiniMed Paradigm Veo Insulin Pump Product Catalog Number: MMT-554, MMT-754
Diabetes Devices·239,859 affected·Apr 24, 2018
High RiskFDA
Tandem Diabetes Care Inc
t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM Software version: 4.3.4.3, Firmware version: 004722, Firmware, Fuel Gauge, Binary R...
Diabetes Devices·55 affected·Apr 23, 2018
High RiskFDA
Mhc Medical Products Llc
EasyTouch (ET) Insulin Syringe 29G 1ml ¿" (Item 829155) Product Usage: INTENDED FOR INJECTION OF U100 INSULIN ONLY
Diabetes Devices·3,137 affected·Apr 6, 2018
High RiskFDA
Mhc Medical Products Llc
EasyTouch (ET) Insulin Syringe 29G 0.5ml ¿" (Item 829555) Product Usage: INTENDED FOR INJECTION OF U100 INSULIN ONLY
Diabetes Devices·46,600 affected·Apr 6, 2018
High RiskFDA
Tosoh Bioscience Inc
Tosoh ST AIA-PACK HbA1c, HbA1c Reagent, Pt. No. 025218 The device is designed for In Vitro Diagnostic Use Only for the quantitative me...
Diabetes Devices·6,049 affected·Mar 5, 2018
High RiskFDA
Tosoh Bioscience Inc
ST-AIA PACK C-Peptide; Part Number: 025284 Assay, Diabetes
Diabetes Devices·1,358 affected·Mar 5, 2018
High RiskFDA
Beckman Coulter Inc.
BECKMAN COULTER iChemVELOCITY, Urine Chemistry System, Catalog Numbers: 800-3530, 800-7167, 800-7719, 800-7720, 800- 7106, 800-3049, 80...
Diabetes Devices·2,225 affected·Mar 2, 2018
High RiskFDA
Roche Diagnostics Corporation
cobas b 221 AutoQC Module Complete; Catalog numbers: 3313522001 and 3313522692 The Roche Diagnostics Omni S Analyzer is a fully automa...
Diabetes Devices·1,026 affected·Feb 22, 2018
High RiskFDA
Roche Diagnostics Corporation
cobas b 221<2>Roche OMNI S2 system catalog numbers: 3337111001 and 3337111692 The Roche Diagnostics Omni S Analyzer is a fully automa...
Diabetes Devices·1,026 affected·Feb 22, 2018
High RiskFDA
Roche Diagnostics Corporation
cobas b 221<6>Roche OMNI S6 system; Catalog numbers: 3337154001 and 3337154692 The Roche Diagnostics Omni S Analyzer is a fully autom...
Diabetes Devices·1,026 affected·Feb 22, 2018
High RiskFDA
Cardinal Health 200, Llc
Presource PBDS, Kit, No Spiro Diabetes. Kit includes a exerciser volumetric 5000 ML device, two items of cloth, skin prep 2% CHG, a pack...
Diabetes Devices·8,928 affected·Feb 20, 2018
High RiskFDA
Cardinal Health 200, Llc
Presource PBDS, Kit, Common Diabetes. Kit includes a exerciser volumetric 5000 ML device, two items of cloth, skin prep 2% CHG, a packet...
Diabetes Devices·8,928 affected·Feb 20, 2018
High RiskFDA
Allison Medical, Inc.
InControl Insulin Syringes, Short Needle, 29 Gauge, 1CC
Diabetes Devices·1,500 affected·Jan 19, 2018
High RiskFDA
Beckman Coulter Inc.
iChem VELOCITY Urine Chemistry Strips, REF 800-7212 Product Usage: The iChem VELOCITY automated urine chemistry system is an in vitro...
Diabetes Devices·14,340 affected·Dec 4, 2017
High RiskFDA
Walkmed, Llc
Reservoir Bag for WalkMed Infusion Pump Part Number 204820 Catalog Number IPR-86/10 65 mL and Reservoir Bag for WalkMed Infusion Pump Par...
Diabetes Devices·25,920 affected·Sep 27, 2017
High RiskFDA
Beckman Coulter Inc.
Lyophilized Chemistry Calibrator Level 1 Product Usage: Beckman Coulter Chemistry Calibrators are intended for use when calibrating ...
Diabetes Devices·0 affected·Aug 24, 2017
High RiskFDA
Novo Nordisk Inc
Dial-A-Dose Insulin Delivery Device (Pen-Injector) cartridge holders Product Usage: The NovoPen Echo¿ is a re-usable pen injector for...
Diabetes Devices·16,557 affected·Jul 5, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Glucose (GLUC) assay (Product Number: DF40/10444973) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Diabetes Devices·80,466 affected·Jun 29, 2017
High RiskFDA
Roche Diabetes Care, Inc.
Accu-Chek Aviva II Meter - Product Usage: a. The Accu-Chek Aviva Plus Blood Glucose Monitoring System is intended to be used for the quan...
Diabetes Devices·26,600 affected·Jun 12, 2017
High RiskFDA
Roche Diabetes Care, Inc.
Accu-Chek Performa II Meter - Product Usage: a. The Accu-Chek Aviva Plus Blood Glucose Monitoring System is intended to be used for the q...
Diabetes Devices·0 affected·Jun 12, 2017
High RiskFDA
Roche Diabetes Care, Inc.
Accu-Chek Connect diabetes management software app, Catalog number 07562462001 / GTIN number 00365702700000, Catalog number 07250452001 /...
Diabetes Devices·1,134 affected·Jun 8, 2017
High RiskFDA
Roche Diabetes Care, Inc.
Accu-Chek Connect Diabetes Management App, Catalog number 07562462001 / GTIN number 00365702700000 & Catalog number 07250452001 / GTIN nu...
Diabetes Devices·67,040 affected·Jun 8, 2017
High RiskFDA
Becton Dickinson & Company
BD Precision Glide Needle 18G x 1 RB, Catalog 305195 Product Usage: These needles are intended for general purpose fluid injection/a...
Diabetes Devices·2,598,000 affected·May 31, 2017
High RiskFDA
Beckman Coulter Inc
Beckman Coulter Synchron AQUA CAL Level 1, Part No. 471288 Product Usage: Used for the system calibration of Na, K, Cl, Urea N, Urea,...
Diabetes Devices·4,444 affected·May 15, 2017
High RiskFDA
Medtronic Inc.
MiniMed 670G Insulin Infusion Pump, Catalog No. MMT-1580, MMT-1780, MMT-1782, MMT-1760.
Diabetes Devices·117,239 affected·May 8, 2017
High RiskFDA
Medtronic Inc.
MiniMed 620G Insulin Infusion Pump, Catalog No. MMT-1510, MMT-1710, MMT-1550, MMT-1750.
Diabetes Devices·6,573 affected·May 8, 2017
High RiskFDA
Medtronic Inc.
MiniMed 630G Insulin Infusion Pump, Catalog No. MMT-1715, MMT-1755.
Diabetes Devices·65,959 affected·May 8, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Systems Insulin ReadyPack; Test Code: IRI; Catalog Number: 02230141, for in vitro diagnostic use in the quantitative determ...
Diabetes Devices·0 affected·Apr 5, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Systems Insulin Calibrator; Test Code: Calibrator IRI; Catalog Number: 04618899
Diabetes Devices·0 affected·Apr 5, 2017
High RiskFDA
Roche Diabetes Care, Inc.
Accu-Chek Connect Diabetes Management App versions 2.0.0, 2.0.1 and 2.1.0 for iOS and Android Product Usage: This is a digital produc...
Diabetes Devices·64,324 affected·Mar 14, 2017
High RiskFDA
Beckman Coulter Inc.
iChemVELOCITY Urine Chemistry System, Catalog No. 800-3530, 800-7167, 800-7719, 800-7720, 800-3564, 800-7100, 800-7103, 800-7106, 800-716...
Diabetes Devices·3,175 affected·Jan 30, 2017
High RiskFDA
Radiometer America Inc
ABL90 Flex Model #: 393-090 Portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin, a...
Diabetes Devices·9,688 affected·Jan 26, 2017
High RiskFDA
Becton Dickinson & Company
BD FlowSmart Set MiniMed Pro-set Rx Only Distributed by Medtronic MiniMed Inc. 8006464633 8185765555 Legal Manufacturer Becton...
Diabetes Devices·57,750 affected·Dec 23, 2016
High RiskFDA
Roche Diabetes Care, Inc.
Accu-Chek Connect Diabetes Management App
Diabetes Devices·27,243 affected·Dec 20, 2016
High RiskFDA
Roche Diagnostics Operations, Inc.
MSS CASSETTE GLU/LAC/UREA (BUN) as a part of the Roche OMNI S Analyzer: cobas b 221<6>Roche OMNI S6 system The Roche Diagnostics Omni S...
Diabetes Devices·97 affected·Oct 31, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Advia Chemistry Calibrator For in vitro diagnostic use in the calibration of ADVIA¿ Chemistry systems for the following methods: Albumi...
Diabetes Devices·10,614 affected·Oct 7, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista Chemistry 1 Calibrator The Chemistry 1 Calibrator (KC110B) is an in vitro diagnostic product for the calibration of Calc...
Diabetes Devices·9,935 affected·Sep 15, 2016
High RiskFDA
Azer Scientific, Inc.
Glucose Tolerance Beverage- Orange 50 gram Concentration, Liquid 4/Pack of 6 bottles, 24/case Accessory to an In Vitro Diagnostic Oral ...
Diabetes Devices·426 affected·Aug 24, 2016
High RiskFDA
Azer Scientific, Inc.
Fruit Punch Glucose, 100 Gram Concentration, Liquid, 4/Pack of 6 Bottles, 24/cs Accessory to an In Vitro Diagnostic Oral Glucose Tolera...
Diabetes Devices·1,141 affected·Aug 24, 2016
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products TRIG Slides, REF/Product Codes 133 6544 (300 slides per sales unit) and 832 9930 (90 slides per sales unit), Un...
Diabetes Devices·60,372 affected·Aug 11, 2016