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
Greenberg Fruit Co
onions/yellow sliced, Label states "Joe's Pride" and bears the address 9705 I Street, Omaha, NE 68127. Product is packaged in poly bags ...
Produce·8 affected·Jul 15, 2016
CriticalFDA
Greenberg Fruit Co
potato/fries skin on, 4/5lb bags per case, Label states "Joe's Pride" and bears the address 9705 I Street, Omaha, NE 68127. Product is p...
Food·193 affected·Jul 15, 2016
High RiskFDA
Faribault Foods, Inc
No-Salt-Added Black Beans, 15 oz. (425 g), packaged under the following brands: 1. HEB, UPC 41220-91262; 2. Kuner's UPC 72273-136...
Food·10,040 affected·Jul 15, 2016
CriticalFDA
Greenberg Fruit Co
Cabbage/nappa shredded, Label states "Joe's Pride" and bears the address 9705 I Street, Omaha, NE 68127. Product is packaged in poly bag...
Food·2 affected·Jul 15, 2016
CriticalFDA
Top Taste, Inc
Frozen cinnamon rolls packaged under the following labels: (1) Fetting's Cinnamon Rolls, packaged in 15-oz. plastic bags, 8 rolls per ...
Frozen Food·2,500 affected·Jul 15, 2016
CriticalFDA
Greenberg Fruit Co
potato/sweet potato yam, Label states "Joe's Pride" and bears the address 9705 I Street, Omaha, NE 68127. Product is packaged in poly ba...
Food·4 affected·Jul 15, 2016
CriticalFDA
Greenberg Fruit Co
onions/red sliced, Label states "Joe's Pride" and bears the address 9705 I Street, Omaha, NE 68127. Product is packaged in poly bags ins...
Produce·12 affected·Jul 15, 2016
CriticalFDA
Greenberg Fruit Co
skin on raw whole potatoes, 10oz #2 in 50lb plastic bags , Label states "Joe's Pride" and bears the address 9705 I Street, Omaha, NE 6812...
Food·13 affected·Jul 15, 2016
CriticalFDA
The Harvard Drug Group
Diocto Liquid (docusate sodium) 50 mg/5 mL Stool Softener Laxative, One Pint (473 mL) bottles, Dist by: Rugby Laboratories, Livonia, MI -...
Drugs·153,432 affected·Jul 15, 2016
Medium RiskFDA
Teva North America
Children's Qnasl 40 mcg (beclomethasone dipropionate) Nasal Aerosol, 40 mcg per spray, 60 Metered Sprays per canister, 4.9g Net Contents,...
Inhaled / Nasal Drugs·193,320 affected·Jul 15, 2016
High RiskFDA
Roche Diagnostics Operations, Inc.
Roche/Hitachi MODULAR Analytics Combination Systems Modular D/P: Clinical Chemistry Analyzer, Chemistry (Photometric, Discrete) for clin...
Diagnostic Devices·9,014 affected·Jul 15, 2016
High RiskFDA
Roche Diagnostics Operations, Inc.
cobas p 471 centrifuge unit calculator/data processing module, for clinical use Product Usage: The cobas p312 pre-analytical system ...
Medical Devices·9,014 affected·Jul 15, 2016
High RiskFDA
Roche Diagnostics Operations, Inc.
cobas p 701 Post-Analytical Unit calculator/data processing module, for clinical use Product Usage: The URISYS 2400 Analyzer is a fu...
Diabetes Devices·9,014 affected·Jul 15, 2016
High RiskFDA
Roche Diagnostics Operations, Inc.
VS II Aliquoter System calculator/data processing module, for clinical use Product Usage: Elecysy 411 analyzer is a fully automated,...
Medical Devices·9,014 affected·Jul 15, 2016
High RiskFDA
Elekta, Inc.
MOSAIQ Oncology Information System
Medical Devices·383 affected·Jul 15, 2016
High RiskFDA
Roche Diagnostics Operations, Inc.
URISYS 2400 Urine Analyzer Automated Urinalysis System Product Usage: The RSD 800 is a computer-controlled stand-alone sorting syste...
Medical Devices·9,014 affected·Jul 15, 2016
High RiskFDA
Topcon Medical Laser Systems, Inc
Opthalmic: PASCAL Synthesis is an ophthalmic scanning laser system. The system can perform single shot photocoagulation as is performed ...
Medical Devices·205 affected·Jul 15, 2016
High RiskFDA
Hill-rom, Inc.
Affinity Four Birthing Bed Model P3700 The primary packaging is pictured below, and utilizes a metal packing brace, standard corruga...
Medical Devices·94 affected·Jul 15, 2016
High RiskFDA
Roche Diagnostics Operations, Inc.
RSD 800 Sorting System calculator/data processing module, for clinical use Product Usage: The cobas 8000 Modular Analyze Series is a...
Medical Devices·9,014 affected·Jul 15, 2016
High RiskFDA
Roche Diagnostics Operations, Inc.
cobas p 501 Post-Analytical Unit calculator/data processing module, for clinical use Product Usage: The MODULAR PRE-ANALYTICS system...
Medical Devices·9,014 affected·Jul 15, 2016
High RiskFDA
Roche Diagnostics Operations, Inc.
cobas p 512 Pre-Analytical Instrument calculator/data processing module, for clinical use Product Usage: The cobas 6800/8800 systems...
Diagnostic Devices·9,014 affected·Jul 15, 2016
High RiskFDA
Ethicon Endo-surgery Inc
Endoscopic Articulating Linear Cutter, ATB35. Standard 35 MM. The ENDOPATH ETS-Flex Endoscopic Articulating Linear Cutter has applicatio...
Medical Devices·105 affected·Jul 15, 2016
CriticalFDA
Monogram Appetizers, Inc
Poppers brand Mozzarella Cheese Sticks Net Wt. 32 oz. (2 lb) 970 g. Keep Frozen. Cook Thoroughly. UPC 46704-88920. Distributed by: H...
Dairy·5,980 affected·Jul 14, 2016
High RiskFDA
Ajinomoto Windsor Inc., Golden Tiger Plant
Molly's Kitchen Hotzzarella Cheese Sticks, 12 lbs., Item No. 582648; Fred's Hotzzarella Cheese Sticks, 12lbs., Item No. 0204320.
Dairy·2,962 affected·Jul 14, 2016
High RiskFDA
Intuitive Surgical, Inc.
STAPLER 45, IS4000, model number 470298 Gastroenterology/Urology: The Intuitive Surgical da Vinci EndoWrist¿ Stapler 45, Stapler 45 Re...
Surgical Devices·2,065 affected·Jul 14, 2016
High RiskFDA
Straumann Manufacturing, Inc.
Straumann Bone Level Implant, ¿ 4.1mm RC, SLA¿ 12mm, TiZr, NTP Article Number: 021.4512
Medical Implants·33 affected·Jul 14, 2016
High RiskFDA
Merge Healthcare, Inc.
Merge RadSuite,f/k/a: Emageon Advanced Visualization , RadSuite versions 8.30.7.8, 8.30.7.9, 8.30.8, and 8.31. Advanced Visualization (I...
Diagnostic Devices·29 affected·Jul 14, 2016
High RiskFDA
Intuitive Surgical, Inc.
STAPLER,IS4000; Model number 470298; General and Plastic Surgery: The Intuitive Surgical da Vinci EndoWrist Stapler 45, Stapler 45 Re...
Surgical Devices·875 affected·Jul 14, 2016
High RiskFDA
Diagnostic Hybrids, Inc.
MicroVue BAP EIA, Model 8012, provides a quantitative measure of bone-specific alkaline phosphatase (BAP) activity in serum.
Medical Devices·1,004 affected·Jul 14, 2016
High RiskFDA
Ortho-clinical Diagnostics
VITROS Immunodiagnostic Products Estradiol Reagent Pack, Unique Device Identifier No. 10758750005017, REF/Catalog Number/Product Code 855...
Diagnostic Devices·1,620 affected·Jul 14, 2016
High RiskFDA
Intuitive Surgical, Inc.
STAPLER 30,IS4000; Model number 470430; General and Plastic Surgery: The Intuitive Surgical da Vinci EndoWrist Stapler 30 Instrument ...
Surgical Devices·875 affected·Jul 14, 2016
High RiskFDA
Productos La Finca, Inc.
Iberia Codfish Fritter Mix
Seafood·282 affected·Jul 13, 2016
CriticalFDA
Icc/marie Callender's Products
Marie Callender's Cheese Biscuit, Restaurant Style; Packaged in 7 oz. and 14 oz. Stand-up pouches. UPC - 7 oz. 075968-14015-0, Item num...
Dairy·7 affected·Jul 13, 2016
High RiskFDA
Innovative Food Processors, Inc.
Prime CAP Sugar, S 95-135, Encapsulated Sugar. Ingredients: Sugar and Hydrogenated Palm Oil, #10040870, Net WT. 125 lbs. Poly lined car...
Food·196,000 affected·Jul 13, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
ARTIS Q AND Q.ZEN- MODULAR ANGIOGRAPHIC SYSTEM, interventional fluoroscopic x-ray system22 AXIOM Artis, Artis zee / zeego and Artis Q...
Cardiac Devices·11,111 affected·Jul 13, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
ARTIS ZEE AND ZEEGO, system, x-ray, angiographic AXIOM Artis, Artis zee / zeego and Artis Q/ Q.zen are a family of dedicated angiography...
Cardiac Devices·11,111 affected·Jul 13, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Definition AS with software version VA48A-SP2; Model # 10430603, computed tomography x-ray system
Medical Devices·1 affected·Jul 13, 2016
High RiskFDA
Accessclosure, Inc., A Cardinal Health Company
6F/7F MynxGrip Vascular Closure Device; Product Model MX6721, Product Usage: The 6F/7F MynxGrip Vascular Closure Device is indicated...
Surgical Devices·55 affected·Jul 13, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM, system, x-ray, angiographic AXIOM Artis, Artis zee / zeego and Artis Q/ Q.zen are a family of de...
Cardiac Devices·11,111 affected·Jul 13, 2016
High RiskFDA
Diasorin Inc.
LIAISON Estradiol II Gen, 310680, 310680-CN The DiaSorin LIAISON Estradiol II Gen assay is a chemiluminescent immunoassay (CLIA) inten...
Diagnostic Devices·10,739 affected·Jul 13, 2016
High RiskFDA
Productos La Finca, Inc.
Product label reads in part: "MR.SPECIAL PANCAKES***PANCAKES & WAFFLE MIX***Peso Neto/Net Weight 11 gr"
Bakery & Grains·163 affected·Jul 12, 2016
High RiskFDA
Productos La Finca, Inc.
Product label reads in part: "Maga PANCAKES COCOA***Peso Neto/Net Weight 16 oz (454.8gr)***Productos La Finca, Inc.*** Zona Ind. Machucha...
Bakery & Grains·153 affected·Jul 12, 2016
High RiskFDA
Productos La Finca, Inc.
Product label reads in part: "Maga PANCAKES INTEGRAL BLANCO***WHITE WHOLE GRAIN PANCAKES***Peso Neto/Net Weight 16 oz (454.8gr)***Product...
Bakery & Grains·239 affected·Jul 12, 2016
High RiskFDA
Productos La Finca, Inc.
Product label reads in part: "Maga PANCAKES DE AVENA***OATMEAL PANCAKES***Peso Neto/Net Weight 16 oz (454.8gr)***Productos La Finca, Inc....
Bakery & Grains·749 affected·Jul 12, 2016
High RiskFDA
Productos La Finca, Inc.
Product label reads in part: "SuperMax HARINA DE TRIGO***WHEAT FLOUR"
Food·239 affected·Jul 12, 2016
High RiskFDA
Productos La Finca, Inc.
Product label reads in part: "MR.SPECIAL HARINA DE TRIGO***WHEAT FLOUR***Peso Neto/Net Weight 11 gr"
Food·440 affected·Jul 12, 2016
High RiskFDA
Productos La Finca, Inc.
Product label reads in part: "Maga***ALMOJABANAS***RICE AND WHEAT FLOUR FRITTER MIX***Peso Neto/Net Weight 6 oz (171gr)***Productos La Fi...
Food·513 affected·Jul 12, 2016
High RiskFDA
Productos La Finca, Inc.
Product label reads in part: "Maga PANCAKES COCO***COCONUT PANCAKES***Peso Neto/Net Weight 16 oz (454.8gr)***Productos La Finca, Inc.*** ...
Bakery & Grains·202 affected·Jul 12, 2016