Browse
All Product Recalls
49,209 recalls (high severity)
High RiskFDA
Navilyst Medical, Inc
PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO Technology, 5F-55 cm DUAL LUMEN, UPN Product No. H96560M0367051, REF/Catal...
Medical Devices54 affectedAug 25, 2014
High RiskFDA
Becton Dickinson & Co.
EpiCenter Plus Microbiology Data Management System software version 6.20A, when used in conjunction with the MALDI BioTyper System . P...
Medical Devices115 affectedAug 25, 2014
High RiskFDA
Navilyst Medical, Inc
PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 4F-55 cm SINGLE LUMEN, UPN Product No. H96560M0...
Medical Devices3 affectedAug 25, 2014
High RiskFDA
Navilyst Medical, Inc
BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 5F-55 cm, UPN Product No. H965750141, REF/Catalog No. 75-014, STERILE ---...
Medical Devices65 affectedAug 25, 2014
High RiskFDA
Navilyst Medical, Inc
PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 4F-55 cm SINGLE LUMEN, UPN Product No. H96560M1...
Medical Devices3 affectedAug 25, 2014
High RiskFDA
Navilyst Medical, Inc
BioFlo PICC with ENDEXO Technology and PASV Valve Technology Maximal Barrier Nursing Kit, 5F-55 cm, UPN Product No. H965750191, REF/Catal...
Medical Devices300 affectedAug 25, 2014
High RiskFDA
Navilyst Medical, Inc
PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 4F-55 cm SINGLE LUMEN, UPN Product No. H96560M0...
Medical Devices60 affectedAug 25, 2014
High RiskFDA
Navilyst Medical, Inc
PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 5F-55 cm SINGLE LUMEN, UPN Product No. H96560M1...
Medical Devices45 affectedAug 25, 2014
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 Devices46,050 affectedAug 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 Devices13,900 affectedAug 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 Devices307 affectedAug 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 Devices236 affectedAug 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 Devices339 affectedAug 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 Devices2,771 affectedAug 19, 2014
High RiskFDA
Philips Medical Systems, Inc.
Patient Support Material Number: 9890 010 87431 used with: BuckyDiagnost ; Model: 704060/706037
Diagnostic Devices1,517 affectedAug 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 Devices2,771 affectedAug 19, 2014
High RiskFDA
Philips Medical Systems, Inc.
Patient Support Material Number: 9890 010 87431, used with:EasyDiagnost ; Model: 706050
Diagnostic Devices260 affectedAug 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 Devices858 affectedAug 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 Devices554 affectedAug 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 Devices9,769 affectedAug 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...
Food0 affectedAug 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...
Food0 affectedAug 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....
Food4,063 affectedAug 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...
Food0 affectedAug 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...
Food0 affectedAug 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...
Food0 affectedAug 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 & Candy0 affectedAug 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....
Produce0 affectedAug 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...
Food0 affectedAug 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 Devices84 affectedAug 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 Implants1,147 affectedAug 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 Devices16 affectedAug 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 Devices2 affectedAug 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 Devices1,147 affectedAug 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 Devices2,928 affectedAug 14, 2014
High RiskFDA
The Anspach Effort, Inc.
Synthes Small Electric Drive (SED). For use in general traumatology.
Medical Devices599 affectedAug 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 Drugs56,060 affectedAug 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 Drugs322,650 affectedAug 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 Devices387 affectedAug 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 Devices10,515 affectedAug 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 Devices8,251 affectedAug 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 Devices1,005 affectedAug 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 Devices321 affectedAug 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 Devices22,828 affectedAug 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 Devices16,532 affectedAug 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 Devices865 affectedAug 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 Devices207 affectedAug 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 Devices2,142 affectedAug 13, 2014