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All Product Recalls

49,195 recalls from FDA (high severity)

Source:AllCPSCFDAUSDASeverity:AllCriticalHighMedium
High RiskFDA
Beckman Coulter Inc.
Coulter DxH Diluent, Catalog No. 628017 Blood cell analysis comprises diluting a whole-blood sample with a solution that functions as ...
Medical Devices·46,050 affected·Aug 25, 2014
High RiskFDA
Deroyal Industries Inc
Suction canisters labels as follows: 1) DeRoyal(R) SUCTION CANISTER, 1000cc, SEMI-RIGID, REF 71-6510, NON-STERILE, Rx Only. 2) NOVAPLUS...
Medical Devices·13,900 affected·Aug 22, 2014
High RiskFDA
Philips Medical Systems, Inc.
Ingenia, Intera, Achieva and Achieve dStream MR systems on Software versions R5.1.7 and R5.1.8 with the Mobi View software option. Diag...
Diagnostic Devices·307 affected·Aug 21, 2014
High RiskFDA
Beckman Coulter Inc.
UniCel 600/800 Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative, or qualitative de...
Diagnostic Devices·236 affected·Aug 21, 2014
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products PHYT (Phenytoin) Slides, REF/Product Code 829 8671, IVD. For in vitro diagnostic use only. VITROS Chemistry ...
Diagnostic Devices·339 affected·Aug 20, 2014
High RiskFDA
Siemens Healthcare Diagnostics
ADVIA Centaur XP Immunoassay System (including refurbished units), This system is intended for professional use in a laboratory envir...
Diagnostic Devices·2,771 affected·Aug 19, 2014
High RiskFDA
Philips Medical Systems, Inc.
Patient Support Material Number: 9890 010 87431 used with: BuckyDiagnost ; Model: 704060/706037
Diagnostic Devices·1,517 affected·Aug 19, 2014
High RiskFDA
Siemens Healthcare Diagnostics
ADVIA Centaur Immunoassay System (including refurbished units), This system is intended for professional use in a laboratory environm...
Diagnostic Devices·2,771 affected·Aug 19, 2014
High RiskFDA
Philips Medical Systems, Inc.
Patient Support Material Number: 9890 010 87431, used with:EasyDiagnost ; Model: 706050
Diagnostic Devices·260 affected·Aug 19, 2014
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Siemens CentraLink Data Management System, software version 14. The CentraLink system software is a network solution provider and mu...
Medical Devices·858 affected·Aug 19, 2014
High RiskFDA
Elekta, Inc.
FOCAL Sim Workstation, Radiation Treatment Planning System. Used for patient contouring and viewing of treatment plan outputs. Also ...
Medical Devices·554 affected·Aug 18, 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
Roots Organic Gourmet
Roots, Black Bean Hummus, Net Wt. 8oz (227 g), and 16 oz. (454 g), Gluten-Free Vegan, UPC: 860971000030, and 723175787636, 166 W. Haywood...
Food·0 affected·Aug 15, 2014
High RiskFDA
Roots Organic Gourmet
Roots, Oil Free Original Hummus, Net Wt. 8 oz (227 g), Gluten-Free Vegan, UPC: 723175787599, 166 W. Haywood St., Asheville, NC 2801, Root...
Food·0 affected·Aug 15, 2014
High RiskFDA
Roots Organic Gourmet
Roots, Original Hummus, Net Wt. 8oz (227 g), and 16oz (454 g), Gluten-Free Vegan, UPC: 860971000009, and 723175787629, 166 W. Haywood St....
Food·4,063 affected·Aug 15, 2014
High RiskFDA
Roots Organic Gourmet
Roots, Roasted Garlic Hummus, Net Wt. 8oz (227 g), Gluten-Free Vegan, UPC: 860971000016, 166 W. Haywood St., Asheville, NC 2801, RootsFoo...
Food·0 affected·Aug 15, 2014
High RiskFDA
Roots Organic Gourmet
Roots, Thai Coconut Curry Hummus, Net Wt. 8oz (227 g), Gluten-Free Vegan, UPC: 860971000092, 166 W. Haywood St., Asheville, NC 2801, Root...
Food·0 affected·Aug 15, 2014
High RiskFDA
Roots Organic Gourmet
Roots, Roasted Red Bell Pepper Hummus, Net Wt. 8oz (227 g), and 16oz. (454 g), Gluten-Free Vegan, UPC: 860971000023, and 723175787605, 16...
Food·0 affected·Aug 15, 2014
High RiskFDA
Roots Organic Gourmet
Roots, Hot Chipotle Hummus, Net Wt. 8oz (227 g), and 16 oz. (454 g), Gluten-Free Vegan, UPC: 860971000054, and 723175787612, 166 W. Haywo...
Snacks & Candy·0 affected·Aug 15, 2014
High RiskFDA
Roots Organic Gourmet
Roots, Spinach Hummus, Net Wt. 8 oz (227 g), Gluten-Free Vegan, UPC: 860971000047, 166 W. Haywood St., Asheville, NC 2801, RootsFood.com....
Produce·0 affected·Aug 15, 2014
High RiskFDA
Roots Organic Gourmet
Roots, Lima Bean Hummus, Net Wt. 8 oz (227 g), Gluten-Free Vegan, UPC: 723175787599, 166 W. Haywood St., Asheville, NC 2801, RootsFood.co...
Food·0 affected·Aug 15, 2014
High RiskFDA
Data Innovations, Llc
ProVue Instrument Driver for JResultNet (ProVue.jrm) v. 1.5.3 and below JResultNet is a stand-alone software package that provides con...
Diagnostic Devices·84 affected·Aug 15, 2014
High RiskFDA
Stryker Howmedica Osteonics Corp.
Stryker Howmedica Osteonics RESTORATION Acetabular Augment System; Howmedica Osteonics Corp., A subsidiary of Stryker Corporation Made i...
Medical Implants·1,147 affected·Aug 15, 2014
High RiskFDA
Lumenis, Inc.
Array LaserLink, Manufactured by Lumenis, The Array" LaserLink" is a laser system accessory intended for use in the treatment of ocula...
Medical Devices·16 affected·Aug 15, 2014
High RiskFDA
Medtronic Cardiovascular Surgery-the Heart Valve Division
Hancock Apical Left Ventricle Connector, Model No. H174Axx, Catalog No. 0174ACP012. Used use in conjunction with Hancock Conduit Model...
Medical Devices·2 affected·Aug 15, 2014
High RiskFDA
Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics Triathlon femoral component. Howmedica Osteonics Corp., A subsidiary of Stryker Corporation Made in USA Sterile. ...
Medical Devices·1,147 affected·Aug 15, 2014
High RiskFDA
Biomedix, Inc.
Biomedix SELEC-3 I.V. Administration Set. Individually sealed into a Tyvek¿ and LDPE/PET pouch. Secondary packaging includes 48 pouched...
Medical Devices·2,928 affected·Aug 14, 2014
High RiskFDA
The Anspach Effort, Inc.
Synthes Small Electric Drive (SED). For use in general traumatology.
Medical Devices·599 affected·Aug 14, 2014
High RiskFDA
Fresenius Kabi Usa, Llc
PROPRANOLOL HYDROCHLORIDE INJECTION, USP 1 mg/mL, 1 mL Single Dose Vial, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173, NDC 6332...
Injectable Drugs·56,060 affected·Aug 13, 2014
High RiskFDA
Vistapharm, Inc.
METOCLOPRAMIDE ORAL SOLUTION, USP 5 mg/5 mL, (present as the hydrochloride), 10 mL cups, Rx only. Manufactured by VistaPharm Inc., Largo,...
Oral Drugs·322,650 affected·Aug 13, 2014
High RiskFDA
Vapotherm, Inc.
Vapotherm Precision Flow,Disposable Patient Circuit PFNODPC-High. For use with the Precision Flow system and Ikaria INOmax DSIR ¿ Syst...
Respiratory Devices·387 affected·Aug 13, 2014
High RiskFDA
Siemens Healthcare Diagnostics
ADVIA Centaur XP Immunoassay System, Catalog Numbers/Siemens Material Numbers (SMN) 10285219, 10316507, 10317207, 10317284, 10319668, 103...
Diagnostic Devices·10,515 affected·Aug 13, 2014
High RiskFDA
Volcano Corporation
Volcano TrakBack II Disposable Pullback Device; Sterile and nonpyrogenic; Single Use. TrakBack II is used to move the catheter stead...
Surgical Devices·8,251 affected·Aug 13, 2014
High RiskFDA
Vapotherm, Inc.
Vapotherm Precision Flow,Disposable Patient Circuit PF-E-DPC-High. For use with the Precision Flow system Precision Flow" is intended...
Respiratory Devices·1,005 affected·Aug 13, 2014
High RiskFDA
Siemens Medical Solutions Usa, Inc.
V5Ms Transesophageal transducers; V5Ms trans-esophageal echocardiograph (TEE) ultrasound transducer is intended primarily for cardiol...
Medical Devices·321 affected·Aug 13, 2014
High RiskFDA
Vapotherm, Inc.
Vapotherm Precision Flow, Disposable Patient Circuit PF-DPC-High. For use with the Precision Flow system Precision Flow" is intended ...
Respiratory Devices·22,828 affected·Aug 13, 2014
High RiskFDA
Maquet Cardiovascular, Llc
Acrobat V Vacuum Off-Pump System OM-9100S Acrobat SUV Vacuum Off-Pump System OM-9000S Axius Xpose 3 Access Device XP-3000 XPOS...
Cardiac Devices·16,532 affected·Aug 13, 2014
High RiskFDA
Vapotherm, Inc.
Vapotherm Precision Flow,Disposable Patient Circuit PFHDPC-Low. For use with the Heliox Precision Flow system Precision Flow" is int...
Respiratory Devices·865 affected·Aug 13, 2014
High RiskFDA
Vapotherm, Inc.
Vapotherm Precision Flow,Disposable Patient Circuit PF-NODPC-Low. For use with the Precision Flow system and Ikaria INOmax DSIR ¿ Sy...
Medical Devices·207 affected·Aug 13, 2014
High RiskFDA
Smith & Nephew, Inc.
RENASYS EZ Negative Pressure Wound Therapy (NPWT) System (RENASYS EZ) for patients who would benefit from a suction device particulary as...
Medical Devices·2,142 affected·Aug 13, 2014
High RiskFDA
Siemens Healthcare Diagnostics
ADVIA Centaur Immunoassay System, Catalog Numbers/Siemens Material Numbers (SMN) 10284980, 10286140, 10309524, 10309525, 10310210, 103132...
Diagnostic Devices·10,515 affected·Aug 13, 2014
High RiskFDA
Gendex Corp
eXpertDC intraoral x-ray, models: eXpert DC, NA, 75 Inch reach; eXpert DC, NA, 65 Inch reach; eXpert DC, CN, 55 Inch reach; eXpert DC, WW...
Medical Devices·651 affected·Aug 12, 2014
High RiskFDA
Siemens Medical Solutions Usa, Inc.
The Siemens Symbia S series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagn...
Medical Devices·877 affected·Aug 12, 2014
High RiskFDA
Siemens Medical Solutions Usa, Inc
AXIOM Luminos dRF system with SW VD10 or on Luminos dRF Max The Axiom Luminos dRF is intended to be used as a universal diagnostic im...
Diagnostic Devices·33 affected·Aug 12, 2014
High RiskFDA
Siemens Medical Solutions Usa, Inc.
The Siemens Symbia T series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagn...
Medical Devices·1,330 affected·Aug 12, 2014
High RiskFDA
Instradent Usa, Inc.
Neodent Titamax WS Cortical Implant ¿4.0 x 5 mm (Endosseous dental implant) Article Number: 109.604 Dental implants are intended for ...
Medical Implants·13 affected·Aug 11, 2014
High RiskFDA
Ge Healthcare, Llc
CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOE, E-sCAiOVE; the Airway Gas Option N-CAiO and respective service ...
Respiratory Devices·748 affected·Aug 8, 2014
High RiskFDA
Beckman Coulter, Inc.
MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Br...
Medical Devices·216,240 affected·Aug 8, 2014