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All Product Recalls

49,195 recalls from FDA (high severity)

Source:AllCPSCFDAUSDASeverity:AllCriticalHighMedium
High RiskFDA
Medtronic Inc. Cardiac Rhythm Disease Management
Medtronic Select CAP Arterial Cannulae. Non-Vented, Carmeda Coated, model CB78722 (22 Fr.). Sterilized using Ethylene Oxide. Non-pyrog...
Medical Devices·19,483 affected·Jan 30, 2014
High RiskFDA
Medtronic Inc. Cardiac Rhythm Disease Management
Medtronic Select 3D Arterial Cannulae. Vented, models 78618 (18 Fr.) and 78620 (20 Fr.). Non-Vented Cannulae, models 78718 (18 Fr.) an...
Medical Devices·19,483 affected·Jan 30, 2014
High RiskFDA
Medtronic Inc. Cardiac Rhythm Disease Management
Medtronic Select 3D Arterial Cannulae. Vented, model 78624 (24 Fr.). Non-Vented Cannulae, model 78724 (24 Fr.). Sterilized using Ethy...
Medical Devices·19,483 affected·Jan 30, 2014
High RiskFDA
Synthes, Inc.
Synthes CMF Battery Powered Driver, Part no. 305.840. Used to place screws in the cranialfacial bones, and to drill and/or tap holes to ...
Medical Devices·20,081 affected·Jan 30, 2014
High RiskFDA
Kci Usa, Inc.
PRE2055US: Prevena Customizable Dressing 5-Pack (US-ONLY) Product Usage: The Prevena Incision Management System is intended to manage...
Surgical Devices·20,850 affected·Jan 30, 2014
High RiskFDA
Kci Usa, Inc.
PRE2001: Prevena Incision Management Customizable System Box Product Usage: The Prevena Incision Management System is intended to man...
Surgical Devices·20,850 affected·Jan 30, 2014
High RiskFDA
Kci Usa, Inc.
PRE2055: Prevena Customizable Dressing 5-Pack Product Usage: The Prevena Incision Management System is intended to manage the environ...
Surgical Devices·20,850 affected·Jan 30, 2014
High RiskFDA
Medtronic Inc. Cardiac Rhythm Disease Management
Medtronic Intersept Custom Tubing Pack which contain Select 3D or Select CAP Arterial Cannulae. Model 3Y90R3, the following model is onl...
Medical Devices·19,483 affected·Jan 30, 2014
High RiskFDA
Medtronic Inc. Cardiac Rhythm Disease Management
Medtronic Select 3D Arterial Cannulae. Vented, model 78622 (22 Fr.). Non-Vented Cannulae, model 78722 (22 Fr.). Sterilized using Ethy...
Medical Devices·19,483 affected·Jan 30, 2014
High RiskFDA
Caraco Pharmaceutical Laboratories Ltd.
Oxcarbazepine Tablets, 300 mg, 100 tablet bottles, Rx Only. Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijiah McCoy...
Oral Drugs·7,005 affected·Jan 29, 2014
High RiskFDA
Pfizer Inc.
GREENSTONE BRAND fluconazole for Oral Suspension, ORANGE FLAVORED, 40 mg/mL, when reconstituted, Rx only, Distributed by Greenstone LLC P...
Oral Drugs·4,155 affected·Jan 29, 2014
High RiskFDA
Implantech Associates Inc
Gelzone Shoulder Sleeve, Catalog Number SLV634, Lot Number 852766. Product Usage: To be used where limb support and/or elevation is...
Medical Devices·300 affected·Jan 29, 2014
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products CDM PROM (Calibration Data Module) No. 0168, Catalog Number/REF 199 9077, used in conjunction with: VITROS Chem...
Diagnostic Devices·284 affected·Jan 29, 2014
High RiskFDA
Rx South Llc Dba Rx3 Pharmacy
Hydroxyprogesterone Caproate 250mg/ml in Sesame Oil, 1 ml injectable solution, in 3 ml single dose syringes; a multi-ingredient compounde...
Injectable Drugs·250 affected·Jan 28, 2014
High RiskFDA
Caraco Pharmaceutical Laboratories, Ltd.
Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx only, 500 count bottles, Manufactured by: Sun Pharmaceutical Inc. Ltd, Andheri (...
Oral Drugs·2,528 affected·Jan 28, 2014
High RiskFDA
Amo Puerto Rico Manufacturing, Inc.
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002, diopter size: 16.0 and 21.0. Indicated for primary implantation...
Medical Implants·169 affected·Jan 28, 2014
High RiskFDA
Alterg, Incorporated
Accessory shorts for the AlterG Anti-Gravity treadmill. Use with the AlterG Anti-Gravity Treadmill for rehabilitation.
Medical Devices·2,221 affected·Jan 28, 2014
High RiskFDA
Savory Foods, Inc.
MARY ANN'S Chocolates Signature Assortment,May Contain Sugar, Chocolate, Butter, Corn Syrup, Assorted Fruit and Nuts, Coconut, Vegetable...
Dairy·3,424 affected·Jan 27, 2014
High RiskFDA
Synthes, Inc.
Synthes Small Notch Titanium Reconstructive Plate Product Usage: The Synthes Small Notch Titanium Reconstructive Plate set offers fix...
Medical Implants·18,747 affected·Jan 27, 2014
High RiskFDA
Synthes, Inc.
Synthes Matrix Mandible Short Threaded Drill Guide intended for oral, maxillofacial surgery; trauma and reconstructive surgery, specifica...
Medical Devices·12 affected·Jan 27, 2014
High RiskFDA
Synthes, Inc.
Synthes 3.2 mm Guide Wire 400mm. Used for guiding the TFN Helical Blade and TFN Lag Screw into the femoral.
Medical Devices·1,132,096 affected·Jan 27, 2014
High RiskFDA
Siemens Medical Solutions Usa, Inc
syngo Dynamics Picture Archiving and Communication System (PACS). Model numbers 10091804, 10091805, 10091806, 10091807, 10091673
Medical Devices·50 affected·Jan 27, 2014
High RiskFDA
Comarco Products, Inc.
IQF Stuffed Brined Jalapeno Peppers w/Gorgonzola Allergen: Milk, Wheat. Prod.Code: 4013 24/30 lb bags - 720 lb totes Keep Frozen ...
Dairy·2,610 affected·Jan 24, 2014
High RiskFDA
Windsor Frozen Foods
Gorgonzola Gems Jalapeno Peppers With Gorgonzola and Cream Cheese Blend 8 oz. (227 g) packages, 6/pack
Dairy·0 affected·Jan 24, 2014
High RiskFDA
Teva Pharmaceuticals Usa
Teva Hydroxyzine Pamoate Capsules, USP, 100 mg, 100- count bottle,Rx only, Distributed by Teva Pharmaceuticals USA, Sellersville, PA. NDC...
Oral Drugs·2,494 affected·Jan 24, 2014
High RiskFDA
Teva Pharmaceuticals Usa
Teva Dextroamphetamine Saccharate, Amphetamine Asparate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, CII, 10 mg (mixed sal...
Oral Drugs·9,796 affected·Jan 24, 2014
High RiskFDA
Teva Pharmaceuticals Usa
Teva Ethambutol Hydrochloride Tablets, USP, 400 mg, 100- count bottle, Rx Only,Distributed by Teva Pharmaceuticals, USA, Sellersville, PA...
Oral Drugs·10,405 affected·Jan 24, 2014
High RiskFDA
Teva Pharmaceuticals Usa
Teva Hydroxyzine Pamoate Capsules, USP, 25 mg, 100- count bottle, Rx Only,Distributed by Teva Pharmaceuticals, USA, Sellersville, PA. NDC...
Oral Drugs·35,746 affected·Jan 24, 2014
High RiskFDA
Philips Medical Systems, Inc.
Philips HeartStart XL+ Defibrillator/Monitor Model: 861290 The HeartStart XL+ is intended for use in a hospital setting by qualified ...
Cardiac Devices·7,157 affected·Jan 24, 2014
High RiskFDA
Carestream Health Inc.
Model Kodak 2100 Intraoral X-Ray System, Catalog Numbers 5303144, 8011579 -- Carestream Health, Inc. 150 Verona Street Rochester, NY 1460...
Diagnostic Devices·347 affected·Jan 24, 2014
High RiskFDA
Carestream Health Inc.
Model Kodak 2200 Intraoral X-Ray System, Catalog Numbers 5303177, 5303169, 5303151, XR-5154323 -- Carestream Health, Inc. Made in France ...
Diagnostic Devices·347 affected·Jan 24, 2014
High RiskFDA
Clarity Medical Systems Inc
RetCam 3, RetCam Portable and RetCam Shuttle; manufactured by Clarity Medical Systems, Inc.; Pleasanton, CA 94588. General ophthalmi...
Medical Devices·166 affected·Jan 24, 2014
High RiskFDA
Hospira Inc.
Plum XL, Micro Macro Plum XL3 with data port, and Micro Macro Plum XL with data port infusion pumps, indicated for intravenous, arterial...
Medical Devices·11,555 affected·Jan 24, 2014
High RiskFDA
Nxstage Medical, Inc.
NxStage PureFlow-B Solution; Model/Catalog Number: RFP-401. Product is packaged in a case containing two individual 5L bags. The Nx...
Medical Devices·969 affected·Jan 24, 2014
High RiskFDA
Hospira Inc.
Plum XL3 Multi line Infusion System, Micro Macro Plum XL3 Multi line Infusion System, and Micro Macro Plum XL Infusion System. Infusion ...
Medical Devices·11,781 affected·Jan 24, 2014
High RiskFDA
Araya, Inc
Marshmallow in the following flavors: chocolate, coconut, cookies and cream, gingerbread, peppermint, red velvet, vanilla Araya Artisan ...
Dairy·2,264 affected·Jan 23, 2014
High RiskFDA
Araya, Inc
Chocolate Gift Boxes: SC 6 Oreos, SC Small 12 Chocolate, SC Small 6 chocolate Araya Artisan Chocolate: 1545 W Grand Parkway S, Katy, TX,...
Snacks & Candy·2,264 affected·Jan 23, 2014
High RiskFDA
Chicken Soup For The Soul Food
Chicken Soup for the Soul Thai-Style Chicken Broth, 32 oz. (2 lb., 907 g. paperboard carton. Distributed by Chicken Soup For The Soul Fo...
Meat & Poultry·2,070 affected·Jan 23, 2014
High RiskFDA
Araya, Inc
Dry fruits covered in chocolate in the following flavors: orange peel, mango cayenne, pear Araya Artisan Chocolate: 1545 W Grand Parkway...
Snacks & Candy·2,264 affected·Jan 23, 2014
High RiskFDA
Araya, Inc
Chocolate S'mores Araya Artisan Chocolate: 1545 W Grand Parkway S, Katy, TX, 77494 Tlf (281) 395-1050 info@arayachocolate.com
Snacks & Candy·2,264 affected·Jan 23, 2014
High RiskFDA
Gotera, Inc
Lenguita Cookies net wt. 6 oz., Distributed by Mama Lycha Foods, Houston TX 77055 toll free (877)MAMALYCHA email contact@mamalycha.com ww...
Bakery & Grains·217 affected·Jan 23, 2014
High RiskFDA
Smith & Nephew Inc
Reflection Interfit Shell, 52 MM OD, 3 HOLE, REF 71336052, QTY 1, STERILE R, Smith & Nephew, Inc. Indications for use include cemented...
Medical Implants·10 affected·Jan 23, 2014
High RiskFDA
Atricure Inc
Reusable Clip Applier Manufactured by AtriCure, Inc., 6217 Centre Park Drive, West Chester, OH 45069. The Reusable Clip Applier (Appli...
Medical Implants·46 affected·Jan 23, 2014
High RiskFDA
Fresenius Kabi Usa, Llc
Heparin Sodium Injection, USP 10,000 USP units per 10 mL (1,000 USP units per mL) For IV or SC use, Multi-Dose Vial, Rx only, NDC 63323-5...
Injectable Drugs·161,650 affected·Jan 22, 2014
High RiskFDA
Carefusion 303, Inc.
SmartSite Needleless Connector, Model No. 2000E The SmartSite Needleless Connectors are sterile, individually packaged connectors. Th...
Medical Devices·3,500,000 affected·Jan 22, 2014
High RiskFDA
Integra Lifesciences Corp.
Malibu Polyaxial Screwdriver, 8.0 Plus, Model Number 91-2109; Malibu Polyaxial Screwdriver, Standard, Model Number 91-2110. 510(k): ...
Medical Implants·40 affected·Jan 22, 2014
High RiskFDA
New Japan International, Inc.
Dried Tapioca Pearl, Net Wt. 7oz, 50 bags/carton, UPC Code 0893467803068
Food·86 affected·Jan 20, 2014
High RiskFDA
Ge Healthcare, Llc
GE Healthcare Precision 500D and Proteus XR/a equipped with Wireless Digital Radiography Option (WDR1). The Wireless DR Imaging Option...
Medical Devices·359 affected·Jan 20, 2014