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
Zimmer, Inc.
00434811113, REF I4348-111-13 Zimmer Trabecular Metal Shoulder Humeral Stem 48 Degrees 11 mm Stem Diameter 130 mm Stem Length Trabec...
Medical Implants·10 affected·Jan 10, 2014
CriticalFDA
Sauer Company The C F
Monarch Breakfast Syrup, in 1.5 oz. portion control cups, Distributed by US Foods, Inc., Rosemont, IL 60018.
Food·759 affected·Jan 9, 2014
CriticalFDA
Schindele Enterprises Dba Midwest Wholesale
SEXY MONKEY, 2000 mg, 1 count blister, Distributed by A Herbal Bio, Inc., Bayside, NY.
Drugs·2 affected·Jan 9, 2014
CriticalFDA
Schindele Enterprises Dba Midwest Wholesale
XZONE GOLD, 1 capsule blister 750 mg, Distributed by: XZONE, Orlando, FL.
Oral Drugs·175 affected·Jan 9, 2014
CriticalFDA
Schindele Enterprises Dba Midwest Wholesale
ExtenZe 600 mg, 30 tablet box, Manufactured for: Biotab Nutraceuticals, Inc., Pasadena, CA.
Oral Drugs·57 affected·Jan 9, 2014
CriticalFDA
Schindele Enterprises Dba Midwest Wholesale
BOOST ULTRA, sexual enhancement dietary supplement, 12-capsule/bottle. Also packaged in 3 pill bottles and 1 pill packs. BoostUtra.com, ...
Oral Drugs·500 affected·Jan 9, 2014
CriticalFDA
Schindele Enterprises Dba Midwest Wholesale
XZEN PLATINUM, 750 mg, Distributed by: XZEN, Los Angeles, CA.
Drugs·89 affected·Jan 9, 2014
CriticalFDA
Schindele Enterprises Dba Midwest Wholesale
Magic For Men, packaged in 1ct blister pack and 12-pill/bottle, 390 mg Manufactured For: BTQ Ski, Inc., Chicago, IL 60638
Oral Drugs·59 affected·Jan 9, 2014
High RiskFDA
Hospira Inc.
Aminosyn 3.5% M Sulfite-Free, A Crystalline Amino Acid Solution* with Maintenance Electrolytes with Phosphorus, 1000 mL bag, Rx only. Ho...
Drugs·15,258 affected·Jan 9, 2014
CriticalFDA
Schindele Enterprises Dba Midwest Wholesale
MiracleZEN Platinum, 1 pill blister pack, 2000 mg capsule, Distributed by: Power Life Distributors, COK Inc., Los Angeles, CA.
Oral Drugs·49 affected·Jan 9, 2014
High RiskFDA
Hospira Inc.
Heparin Sodium 2000 USP Heparin Units per 1000 mL (2 USP Heparin Units/mL) in 0.9% Sodium Chloride Injection, Rx only. Hospira, Lake Fore...
Injectable Drugs·27,780 affected·Jan 9, 2014
High RiskFDA
Mako Surgical Corporation
Restoris Multicompartmental Knee (MCK) System is an implant system designed to be used with MAKO's Robotic Arm Interactive Orthopedic Sys...
Medical Implants·41 affected·Jan 9, 2014
High RiskFDA
Smith & Nephew Inc.
Smith & Nephew RENASYS-AB Abdominal Dressing Kit with Soft Port REF #'s: 66800980 (The RENASYS Soft Port Dressing Kits are used in conj...
Medical Devices·28,250 affected·Jan 9, 2014
High RiskFDA
Medtronic Cardiovascular Surgery-the Heart Valve Division
Product Name: Model 7305- Mosaic Aortic Obturator The Mosaic Aortic Obturators are used with the Mosaic Porcine Aortic Bioprostheses.
Medical Implants·8,276 affected·Jan 9, 2014
High RiskFDA
Smith & Nephew Inc.
Smith & Nephew RENASYS Soft Port REF: 66800799 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure woun...
Medical Devices·162,629 affected·Jan 9, 2014
High RiskFDA
Smith & Nephew Inc.
Smith & Nephew RENASYS-F Foam Dressing Kit with Soft Port REF #'s: 66800794, 66800795, and 66800796 (The RENASYS Soft Port Dressing Kit...
Medical Devices·1,710,773 affected·Jan 9, 2014
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products White Reference Slides, White Correction Factor Slide (WCF), DT Slides, 25 Slides, Part Number J02315; Made in ...
Diagnostic Devices·64 affected·Jan 9, 2014
High RiskFDA
Smith & Nephew Inc.
Smith & Nephew RENASYS-G Sterile, Gauze Dressing Kit with Soft Port REF #'s: 66800961 (The RENASYS Soft Port Dressing Kits are used in ...
Medical Devices·7,353 affected·Jan 9, 2014
High RiskFDA
Smith & Nephew Inc.
Smith & Nephew RENASYS-Gauze with Soft Port Kit REF #'s: 66800933, 66800934, 66800935, and 66800936 (The RENASYS Soft Port Dressing Ki...
Medical Devices·498,980 affected·Jan 9, 2014
RecallFDA
Washington Vegetable Co
Cactus Pads (Nopal) Mexpogroup: Product of Mexico
Food·17 affected·Jan 8, 2014
High RiskFDA
Mindray Ds Usa, Inc. Dba Mindray North America
Panaroma Central Station Product Usage: This device can view real time, store, print, graph, and trend patient clinical and demogra...
Medical Devices·732 affected·Jan 8, 2014
High RiskFDA
Veridex, Llc
CELLTRACKS ANALYZER II¿ (Product Code 9555) Product Usage: The CELLTRACKS ANALYZER II¿ is a semi-automated fluorescence microscope,...
Diagnostic Devices·19 affected·Jan 8, 2014
High RiskFDA
B. Braun Medical, Inc.
SAFSITE¿ Injection Sites and IV Sets manufactured with SAFSITE¿ Injection Sites. A device used to administer fluids from a container t...
Surgical Devices·2,357,944 affected·Jan 8, 2014
High RiskFDA
Agfa Corp.
IMPAX RIS QDOC 5.8
Medical Devices·14 affected·Jan 8, 2014
High RiskFDA
American Importing Co, Inc
Simply balanced, herb mixed freeze dried vegetables all natural, Ingredients: Super sweet corn, edamame, peas, carrots, (carrots, sugar, ...
Dairy·2,288 affected·Jan 7, 2014
High RiskFDA
Synthes, Inc.
Synthes Driving Cap/Threaded Both parts are intended for use in the Tibia system, LFN and RAFN systems. Their function is to insert a ...
Medical Devices·143 affected·Jan 7, 2014
CriticalFDA
Teleflex Medical
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 7.5, Rx only, Product Usage: A tracheal tube is a device inser...
Medical Devices·190,871 affected·Jan 6, 2014
CriticalFDA
Teleflex Medical
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 6.5, Rx only, Product Usage: A tracheal t...
Medical Devices·190,871 affected·Jan 6, 2014
CriticalFDA
Teleflex Medical
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 6.5, Rx only, Product Usage: A tracheal tube is a device inserte...
Medical Devices·190,871 affected·Jan 6, 2014
CriticalFDA
Teleflex Medical
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 8.5, Rx only, Product Usage: A tracheal tube is a device inser...
Medical Devices·190,871 affected·Jan 6, 2014
CriticalFDA
Teleflex Medical
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 7.0, Rx only, Product Usage: A tracheal tube is a device insert...
Medical Devices·190,871 affected·Jan 6, 2014
CriticalFDA
Teleflex Medical
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 7.5, Rx only, Product Usage: A tracheal t...
Medical Devices·190,871 affected·Jan 6, 2014
CriticalFDA
Teleflex Medical
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 9.0, Rx only, Product Usage: A tracheal t...
Medical Devices·190,871 affected·Jan 6, 2014
CriticalFDA
Teleflex Medical
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 8.0, Rx only, Product Usage: A tracheal t...
Medical Devices·190,871 affected·Jan 6, 2014
CriticalFDA
Teleflex Medical
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 9.0, Rx only, Product Usage: A tracheal tube is a device inser...
Medical Devices·190,871 affected·Jan 6, 2014
CriticalFDA
Yukon Concessions Alaska Llc
Mandarin Orange Tozzetti Biscotti - individually wrapped in cellophane. Product is sold under Tonia's Biscotti brand, net wt. 2 oz.
Food·0 affected·Jan 3, 2014
CriticalFDA
Yukon Concessions Alaska Llc
Traditional Toasted Almond Biscotti-individually wrapped in cellophane. Product is sold under Tonia's Biscotti brand, net wt. 2 oz.
Food·0 affected·Jan 3, 2014
CriticalFDA
Yukon Concessions Alaska Llc
Hazelnut Biscotti - individually wrapped in cellophane. Product is sold under Tonia's Biscotti brand, net wt. 2 oz.
Food·0 affected·Jan 3, 2014
CriticalFDA
Yukon Concessions Alaska Llc
Chocolate Delight dipped in Dark Chocolate Biscotti-individually wrapped in cellophane. Product is sold under Tonia's Biscotti brand, ne...
Snacks & Candy·0 affected·Jan 3, 2014
CriticalFDA
Yukon Concessions Alaska Llc
Alaskan Birch Brittle with Dark Chocolate Biscotti-individually wrapped in cellophane. Product is sold under Tonia's Biscotti brand, net...
Snacks & Candy·0 affected·Jan 3, 2014
CriticalFDA
Yukon Concessions Alaska Llc
Cran-Almond Biscotti (cranberry & toasted almond) - individually wrapped in cellophane. Product is sold under Tonia's Biscotti brand, ne...
Produce·0 affected·Jan 3, 2014
CriticalFDA
Yukon Concessions Alaska Llc
Blueberry drizzled in White Chocolate Biscotti-individually wrapped in cellophane. Product is sold under Tonia's Biscotti brand, net wt....
Snacks & Candy·0 affected·Jan 3, 2014
CriticalFDA
L. M. Noodle Company, Llc
Marlyce's Homemade Butterballs
Dairy·50 affected·Jan 3, 2014
CriticalFDA
Yukon Concessions Alaska Llc
Lemon Biscotti dipped in White Chocolate Bag, 13 oz., sold in white windowed paper coated bakery bags, And individually wrapped in cellop...
Snacks & Candy·0 affected·Jan 3, 2014
CriticalFDA
Yukon Concessions Alaska Llc
Almond dipped in Dark Chocolate Biscotti-individually wrapped in cellophane. Product is sold under Tonia's Biscotti brand, net wt. 2 oz.
Snacks & Candy·0 affected·Jan 3, 2014
CriticalFDA
Yukon Concessions Alaska Llc
Cranberry dipped in White Chocolate Biscotti-individually wrapped in cellophane. Product is sold under Tonia's Biscotti brand, net wt. 2...
Snacks & Candy·0 affected·Jan 3, 2014
High RiskFDA
Dr. Reddy's Laboratories, Inc.
a) Walgreens Lansoprazole Delayed Release Capsules, USP 15 mg/Acid Reducer, 14 capsules per Bottle, Dist by Walgreen Company, 200 Wilmot ...
Oral Drugs·58,656 affected·Jan 3, 2014
High RiskFDA
Davol, Inc., Subs. C. R. Bard, Inc.
Composix L/P with Echo PS 6" X 8" Product Code 0144680 The Composix L/P Mesh with Echo PS Positioning System is a non-absorbable steri...
Medical Implants·46 affected·Jan 3, 2014