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
High RiskFDA
Greatbatch Medical
Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog no. D140010, Large Curve catalog no. D140011. The MobiCath...
Cardiac Devices·10,201 affected·Nov 12, 2012
CriticalFDA
Zimmer, Inc.
Zimmer Spine Ardis Inserter, Rx, non-sterile
Medical Devices·315 affected·Nov 12, 2012
High RiskFDA
Biomotion Medical Systems, Llc
SpineSix consists of a motorized treatment table that is controlled by an integral computer. The system is operated by means of 12-inch C...
Medical Devices·28 affected·Nov 12, 2012
CriticalFDA
Hillshire Brands Company
Jimmy Dean French Toast & Sausage Sandwich, Net Wt 3.9 oz (110g); a food service individually butcher paper wrapped, fully cooked frozen ...
Frozen Food·405 affected·Nov 10, 2012
High RiskFDA
Orthovita, Inc., Dba Stryker Orthobiologics.
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Beveled Needle, 6", Part Number 2110-0524 Product ...
Surgical Devices·12 affected·Nov 10, 2012
High RiskFDA
Orthovita, Inc., Dba Stryker Orthobiologics.
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Catheter, 6", Part Number 2110-0503 Product Usage:...
Surgical Devices·69 affected·Nov 10, 2012
High RiskFDA
Orthovita, Inc., Dba Stryker Orthobiologics.
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger, 6", Part Number 2110-0501 Product Usage: ...
Surgical Devices·414 affected·Nov 10, 2012
High RiskFDA
Orthovita, Inc., Dba Stryker Orthobiologics.
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger Delivery System, 4", Part Number 2090-0501 ...
Surgical Devices·411 affected·Nov 10, 2012
High RiskFDA
Orthovita, Inc., Dba Stryker Orthobiologics.
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Reamer, 6", Part Number 2110-0504 Product Usage: ...
Surgical Devices·7 affected·Nov 10, 2012
High RiskFDA
Orthovita, Inc., Dba Stryker Orthobiologics.
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Catheter, 8", Part Number 2110-0526 Product Usage:...
Surgical Devices·27 affected·Nov 10, 2012
High RiskFDA
Orthovita, Inc., Dba Stryker Orthobiologics.
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Beveled Needle, 4", Part Number 2110-0505 Produc...
Surgical Devices·35 affected·Nov 10, 2012
High RiskFDA
Orthovita, Inc., Dba Stryker Orthobiologics.
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Syringe Delivery System, 6", Part Number 2090-0504 ...
Surgical Devices·155 affected·Nov 10, 2012
High RiskFDA
Orthovita, Inc., Dba Stryker Orthobiologics.
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Reamer, 8", Part Number 2110-0525 Product Usage: ...
Surgical Devices·5 affected·Nov 10, 2012
High RiskFDA
Orthovita, Inc., Dba Stryker Orthobiologics.
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger, 8", Part Number 2110-0502 Product Usage:...
Surgical Devices·17 affected·Nov 10, 2012
CriticalFDA
Frito Lay, Inc
Grandma's Peanut Butter Mini Sandwich Creme Cookies, Net WT. 1.71 oz, Frito-Lay, Inc. Plano, TX 75024
Dairy·0 affected·Nov 9, 2012
High RiskFDA
Ranbaxy Inc.
Atorvastatin Calcium Tablets, 10 mg, 90 tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceuticals Inc., Jacksonville, FL 322...
Oral Drugs·120,201 affected·Nov 9, 2012
High RiskFDA
Ranbaxy Inc.
Atorvastatin Calcium Tablets, 20 mg, 90 tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceuticals Inc., Jacksonville, FL 322...
Oral Drugs·203,198 affected·Nov 9, 2012
High RiskFDA
Ranbaxy Inc.
Atorvastatin Calcium Tablets, 40 mg, a) 90 tablets per bottle, b) 500 tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceutic...
Oral Drugs·157,026 affected·Nov 9, 2012
CriticalFDA
Medtronic Neuromodulation
SynchroMed EL, models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, 8627L-18. implantable infusion pump. The pump i...
Medical Implants·174,700 affected·Nov 9, 2012
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, LOGIQ e Ultrasound System. The LOGIQ i/e and Vivid e is a general purpose ultrasound system intended for use by a qual...
Cardiac Devices·588 affected·Nov 9, 2012
High RiskFDA
Spinefrontier, Inc.
Drill Guide - Chameleon FacetFuse Fixation System, Model: 11-00028 Rev. A FacetFuse Drill Guides were designed to provide a concentric...
Medical Implants·13 affected·Nov 9, 2012
High RiskFDA
Biomet, Inc.
EBI XFIX DFS Rail System (Adult Rail Gradual Swivel Clamp). The Biomet Rail System consists of a unilateral external fixator rail, modula...
Medical Devices·49 affected·Nov 9, 2012
CriticalFDA
Medtronic Neuromodulation
Medtronic SynchroMed II, Model 8637, (The SynchroMed¿ II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene ox...
Medical Implants·174,700 affected·Nov 9, 2012
CriticalFDA
Boulder Ice Cream
Yoki Bliss Peanut Butter frozen yogurt, 1 gallon, packaged in plastic containers, manufactured by Fresca Foods, CO.
Dairy·6,988 affected·Nov 8, 2012
CriticalFDA
Boulder Ice Cream
Elvis Ice Cream, 2.5 gallon, packed in a plastic container, manufactured by Fresca Foods, CO.
Dairy·28 affected·Nov 8, 2012
CriticalFDA
Nestle Usa
Nesquik Chocolate Powder, 1) 6x40.7oz, UPC 0 28000 68230 9. 2) 12x21.8oz, UPC 0 28000 68090 9. 3) 12x10.9oz, UPC 0 28000 67990 3.
Snacks & Candy·18,768 affected·Nov 8, 2012
RecallFDA
Whole Foods Market
Whole Foods Market Panettone Chocolate - 26.4 oz, 12 per case.
Snacks & Candy·1,035 affected·Nov 8, 2012
CriticalFDA
Spence & Co., Ltd.
Spence & Co New York-Style Nova Lox 4oz , refrigerated Spence & Co Smoked Salmon Trimmings, 2lb bulk (bag)
Seafood·1,563 affected·Nov 8, 2012
CriticalFDA
Boulder Ice Cream
All Natural Boulder Ice Cream Peanut Butter Cup, 2.5 gallon, packed in plastic packaging, manufactured by Fresca Foods, CO. All Natural ...
Dairy·329 affected·Nov 8, 2012
CriticalFDA
Boulder Ice Cream
Serano Gelato Chocolate Peanut Butter, 16 oz, contained in a semiflexible paper container, manufactured by Fresca Foods, CO.
Dairy·16,928 affected·Nov 8, 2012
High RiskFDA
Procter & Gamble Co
Vicks NyQuil Cold & Flu, Nighttime Relief, 12 FL OZ bottle, Dist. by Proctor and Gamble, Cincinnati, OH 45040. NDC 37000-808-12
Drugs·17,532 affected·Nov 8, 2012
CriticalFDA
Hospira Inc.
Carboplatin Injection, 450 mg/45 mL (10 mg/mL), 45 mL, Cytotoxic Agent, Sterile, Multi-Dose Vial, Rx only, For IV Use, NDC 61703-339-50 (...
Injectable Drugs·31,326 affected·Nov 8, 2012
CriticalFDA
Hospira Inc.
Carboplatin Injection, 600 mg/60 mL (10 mg/mL), 60 mL, Cytotoxic Agent, Sterile, Multi-Dose Vial, Rx only, For IV Use, Hospira, Inc., Lak...
Injectable Drugs·23,315 affected·Nov 8, 2012
High RiskFDA
Moog Medical Devices Group
EnteraLite Infinity Enteral Feeding Pump identified with the following list numbers: INFKIT2 and INFORNG. The device is used with dispos...
Medical Devices·8,736 affected·Nov 8, 2012
High RiskFDA
Medline Industries Inc
Medline Angio Drape Pack Radiology-LF; a sterile custom single patient prescription procedure pack, including a waste bag, for use by the...
Medical Devices·105 affected·Nov 8, 2012
CriticalFDA
Stryker Howmedica Osteonics Corp.
ShapeMatch Cutting Guides Product Usage: The ShapeMatch Cutting Guides are intended to be used as patient-specific surgical instrumen...
Surgical Devices·7,868 affected·Nov 8, 2012
CriticalFDA
Reaction Nutrition Llc
Clinical LIVE Dietary Supplement Immune Support 694.325 mg 90 capsules Distributed by Reaction Nutrition, LLC., Carnegie, PA.
Supplements·600 affected·Nov 7, 2012
CriticalFDA
Fresh Express Incorporated
Fresh Express brand, Fresh Spinach, 9 oz.
Produce·6,610 affected·Nov 7, 2012
High RiskFDA
Ids (immunodiagnostic Systems Ltd.)
25-Hydroxy Vitamin D EIA, Catalog #AC-57F1. Product Usage: The IDS 25-Hydroxy Vitamin D EIA kit is an enzymeimmunoassay intended for ...
Diagnostic Devices·675 affected·Nov 7, 2012
High RiskFDA
Depuy Spine, Inc.
DePuy Spine VIPER POLY SCREW 5.5 8 X80MM Tl Product Code: 1867-15-880 Spinal Implant Component.
Medical Implants·36 affected·Nov 7, 2012
High RiskFDA
Depuy Spine, Inc.
DePuy Spine VIPER POLY SCREW 5.5 10 X 80MM Tl Product Code: 1867-15-180 Spinal Implant Component.
Medical Implants·6 affected·Nov 7, 2012
High RiskFDA
Quanta System, S.p.a.
Eterna Giovinezza System, Powered Laser Surgical Instrument. Permanent hair reduction; Photocoagulation of dermatological vascular les...
Surgical Devices·12 affected·Nov 7, 2012
High RiskFDA
Quanta System, S.p.a.
Ultrawave II EX 1320/ Ultrawave III EX 1320 Powered Laser Surgical Instrument. Nd:YAG 1064 nm: Coagulation and hemostasis of benign vasc...
Surgical Devices·22 affected·Nov 7, 2012
RecallFDA
Hemocue Ab
Analyzing system consists of a small and portable analyzer and plastic microcuvettes. The microcuvette contains reagents deposited on its...
Diagnostic Devices·48 affected·Nov 7, 2012
CriticalFDA
Omya Inc
Ground limestone also known as calcium carbonate. Omya's food grade ground limestone products. All bulk with no product labeling. Pro...
Food·922,250 affected·Nov 6, 2012
High RiskFDA
Cracker Industries, Llc
Beagle Bay Organics Brand Raw Sauerkraut, Kimchi Net. Wt. 16 oz (416g). Product is stored/distributed under refrigeration and is intended...
Food·65 affected·Nov 6, 2012
High RiskFDA
Alkermes, Inc.
VIVITROL (naltrexone for extended-release injectable suspension) a) 380 mg vial NDC 65757-303-02, b) 380 mg vial in kit NDC 65757-300-01,...
Injectable Drugs·3,325 affected·Nov 6, 2012
High RiskFDA
Invacare Corporation
Invacare Height Adjustable (walking) Canes, Model Numbers: 8916, 8917, and 40918-6. The device is packaged six (6) canes per shipping ...
Medical Devices·38,280 affected·Nov 6, 2012