Source

FDA Recalls

The U.S. Food and Drug Administration regulates drugs, medical devices, food, cosmetics, and tobacco products. Recall data here includes pharmaceutical adverse events and drug recalls.

68,659Total Recalls
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68,659 recalls
CriticalFDA
Nspired Natural Foods, Division Of The Hain Celestial Group
MaraNatha Roasted Almond Butter, 340 grams, UPC 51651093057.
Dairy·9,185 affected·Aug 19, 2014
CriticalFDA
Nspired Natural Foods, Division Of The Hain Celestial Group
MaraNatha Organic Roasted Creamy Almond Butter, 16 oz., UPC 51651060219; Whole Foods 365 Organic Creamy Almond Butter, 16 oz., UPC 99482...
Dairy·2,882 affected·Aug 19, 2014
CriticalFDA
Nspired Natural Foods, Division Of The Hain Celestial Group
MaraNatha No Stir Crunchy Peanut Butter, 500 grams, UPC 51651093415.
Dairy·1,703 affected·Aug 19, 2014
CriticalFDA
Nspired Natural Foods, Division Of The Hain Celestial Group
MaraNatha No Stir Crunchy Almond Butter, 12 oz., UPC 51651093699.
Dairy·155,333 affected·Aug 19, 2014
CriticalFDA
Nspired Natural Foods, Division Of The Hain Celestial Group
MaraNatha Organic Roasted Crunchy Almond Butter, 16 oz., UPC 51651092036.
Dairy·181 affected·Aug 19, 2014
RecallFDA
Micro Labs Usa, Inc S
Simvastatin Tablets, USP, 10 mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited, Goa-403 722, INDIA, Manufactured for: Mi...
Oral Drugs·1,008 affected·Aug 19, 2014
Medium RiskFDA
Perrigo Holland Inc
Nicotine Polacrilex Lozenge, 2 mg Mint Mini. 27 Ct Tubes, Over the Counter. Perrigo, 502 Eastern Ave, Plant #6, Allegan, MI 49010. Lab...
Drugs·366,936 affected·Aug 19, 2014
CriticalFDA
Icu Medical, Inc.
STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 60 Drop Primary Set w/2 Clave, STAT 2 Flow Controller, Rotating Luer, Item No. 011-C9...
Medical Devices·1,250 affected·Aug 19, 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
CriticalFDA
Icu Medical, Inc.
83" (211 cm) Appx 10.3 mL, 60 Drop Primary Set w/BCV-Clave, Stat 2 Flow Controller, Clave, Rotating Luer, Item No. B9897. Product Usag...
Medical Devices·100 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
CriticalFDA
Icu Medical, Inc.
STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 20 Drop Primary Set w/2 Clave, STAT 2 Flow Controller, Rotating Luer, Item No. 011-C9...
Medical Devices·3,750 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
CriticalFDA
Specialty Commodities, Inc.
Thien Minh Cashew Kernels, Net Wt. 50 lb. Product of Vietnam
Food·95 affected·Aug 15, 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
CriticalFDA
Mccormick & Company, Inc.
McCormick Ground Oregano in 0.75 oz plastic bottle. UPC NUMBER: 52100003566 (as seen on label: 0-523561-6) MCCORMICK ITEM NUMBER: 900356
Food·1,032 affected·Aug 13, 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
CriticalFDA
Biofire Defense
JBAIDS Instrument System Software version 3.5.0.72. The JBAIDS instrument is a portable thermocycler and real-time fluorimeter capable...
Medical Devices·43 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