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
Gills Onions, Llc
Yellow Onion Puree, 38lbs, "Gills Onions" label, no UPC.
Produce·787,457 affected·Jul 17, 2012
CriticalFDA
Gills Onions, Llc
Diced Celery and Onion, 7 oz, UPC 643550000429; Diced Celery and Onion, 19 oz, UPC 643550000351; Diced Celery and Onions, 8oz, UPC 6...
Produce·787,457 affected·Jul 17, 2012
CriticalFDA
Gills Onions, Llc
Red Onion Puree, 38lbs, "Gills Onions" label, no UPC.
Produce·787,457 affected·Jul 17, 2012
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Siemens ADVIA Centaur¿ Syphilis (SYPH) Assay , 200 ReadyPack Reference Number 10492493 Product Usage: The ADVIA Centaur Syphilis (...
Diagnostic Devices·2,050 affected·Jul 17, 2012
High RiskFDA
Conformis Inc
Conformis iTotal CR-Cruciate Retaining Knee Replacement System Model Numbers: M57250600010 iTotal CR, Left Knee M57250600020 iTotal...
Medical Implants·1,427 affected·Jul 17, 2012
CriticalFDA
Siemens Healthcare Diagnostics, Inc.
Dimension(R) Reagent Management System (RMS) - Power Cord. The Siemens Healthcare Diagnostics Dimension(R) clinical chemistry analyzer...
Diagnostic Devices·2,554 affected·Jul 17, 2012
RecallFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista(R) Vancomycin Flex(R) Reagent Cartridge (VANC, Catalog # K4086). For the quantitative measurement of vancomycin in hum...
Diagnostic Devices·1,894 affected·Jul 17, 2012
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
RF Cannula, 100 mm,Curved 10 MM, 20 G, REF 0406-630-125 RX only, Disposable ( 10/pk) Product Usage: The Stryker RF Cannulae, in com...
Surgical Devices·226 affected·Jul 17, 2012
High RiskFDA
Nico Corp.
13.5 mm x 60 mm BrainPath Sheath The NICO BrainPath is a family of products that consists of multiple sized reusable and re-sterilizab...
Medical Devices·15 affected·Jul 17, 2012
High RiskFDA
Flywheel's Pies
Pineapple Pies Case Label (side 1) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Cocoa, Coconut, Sugar, Butter, Vanilla...
Dairy·0 affected·Jul 16, 2012
High RiskFDA
Flywheel's Pies
Sugar Free Apple Pies Case Label (side 1) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Cocoa, Coconut, Butter, Vanilla, Co...
Dairy·0 affected·Jul 16, 2012
High RiskFDA
Flywheel's Pies
Sweet Potato Pies Case Label (side 1) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Cocoa, Coconut, Sugar, Butter, Vanil...
Dairy·0 affected·Jul 16, 2012
High RiskFDA
Flywheel's Pies
Strawberry Pies Case Label (side 1) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Cocoa, Coconut, Sugar, Butter, Vanilla...
Dairy·0 affected·Jul 16, 2012
High RiskFDA
Meiko Food Company Inc
Meiko Foods Co. Inc. Cooked Cuttlefish Ball, 2-10 lb bags . Product labeling reads in part:" MEIKO***Muc Vien [Vietnamese] ***MEIKO FOODS...
Seafood·16 affected·Jul 16, 2012
High RiskFDA
Meiko Food Company Inc
Meiko Foods Co. Inc. Tempura, 12 oz. Product labeling reads in part:" MEIKO***TEMPURA ***MEIKO FOODS CO. INC South El Monte, CA***". T...
Food·25 affected·Jul 16, 2012
High RiskFDA
Meiko Food Company Inc
Meiko Foods Co. Inc. Pollock Fish Balls , 2-10 lb bags. Product labeling reads in part:" MEIKO***POLLOCK FISH BALL S***MEIKO FOODS CO. IN...
Seafood·53 affected·Jul 16, 2012
High RiskFDA
Flywheel's Pies
Chocolate Pies: Case Label (side 1) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Cocoa, Coconut, Sugar, Butter, Vanilla...
Dairy·0 affected·Jul 16, 2012
High RiskFDA
Flywheel's Pies
Coconut Pies: Case Label (side 1) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Cocoa, Coconut, Sugar, Butter, Vanilla, ...
Dairy·0 affected·Jul 16, 2012
High RiskFDA
Meiko Food Company Inc
Meiko Foods Co. Inc. Cooked Shrimp Balls, 8 oz. Product labeling reads in part:" TOM VIEN COOKED SHRIMP BALLS***MEIKO FOODS CO. INC South...
Seafood·1 affected·Jul 16, 2012
High RiskFDA
Flywheel's Pies
Peach Pies Case Label (side 1) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Cocoa, Coconut, Sugar, Butter, Vanilla, Cor...
Dairy·0 affected·Jul 16, 2012
High RiskFDA
Flywheel's Pies
Lemon Pies Case Label (side 1) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Cocoa, Coconut, Sugar, Butter, Vanilla, Cor...
Dairy·0 affected·Jul 16, 2012
High RiskFDA
Flywheel's Pies
Blackberry Pies Case Label (side 1) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Cocoa, Coconut, Sugar, Butter, Vanilla...
Dairy·0 affected·Jul 16, 2012
High RiskFDA
Flywheel's Pies
Apricot Pies Case Label (side 1) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Cocoa, Coconut, Sugar, Butter, Vanilla, C...
Dairy·0 affected·Jul 16, 2012
High RiskFDA
Flywheel's Pies
Cherry Pies Case Label (side 1) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Cocoa, Coconut, Sugar, Butter, Vanilla, C...
Dairy·0 affected·Jul 16, 2012
High RiskFDA
Flywheel's Pies
Blueberry Pies Case Label (side 1) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Cocoa, Coconut, Sugar, Butter, Vanilla,...
Dairy·0 affected·Jul 16, 2012
High RiskFDA
Flywheel's Pies
Apple Pies Case Label (side 1) 24 COUNT FRAGILE FLYWHEEL'S PIES, PRESCOTT, AR Ingredients: Cocoa, Coconut, Sugar, Butter, Vanilla, Corns...
Dairy·0 affected·Jul 16, 2012
CriticalFDA
Coral Rock Man, Inc.
Z-ROCK All Natural Male Supplement. 1 capsule blister pack, UPC 0 00309 50792 7, Distributed by Zrock USA PO Box 668297, Pompano Beach, F...
Oral Drugs·0 affected·Jul 16, 2012
CriticalFDA
Coral Rock Man, Inc.
X-ROCK 3 Day Pill For Men, supplied in 1 and 2 capsule blister packs and 6, 12 and 24 count bottles, UPC 0 00309 50792 7, Distributed by:...
Oral Drugs·0 affected·Jul 16, 2012
High RiskFDA
Roche Molecular Systems, Inc.
DataCare POC  is an information management system that provides data management functionality for managing point-of -care testing data.
Medical Devices·126 affected·Jul 16, 2012
High RiskFDA
Roche Molecular Systems, Inc.
The MagNA Pure 96 System (versions 1.0 and 2.0) is a sample preparation instrument for automated isolation of nucleic acids in various...
Diagnostic Devices·13 affected·Jul 16, 2012
High RiskFDA
Roche Molecular Systems, Inc.
LightCycler 1.2 (software version 3.5) is a Rapid PCR analyzer with real-time detection and/or quantification of a target NA (nucleic aci...
Diagnostic Devices·3,772 affected·Jul 16, 2012
High RiskFDA
Roche Molecular Systems, Inc.
LightCycler 2.0 Instrument (software version 4.1) is a Rapid PCR analyzer with real-time detection and/or quantification of a target NA (...
Medical Devices·1,213 affected·Jul 16, 2012
High RiskFDA
Roche Molecular Systems, Inc.
The MagNA Pure LC (version 3.0) is a sample preparation instrument that can be used with the LightCycler instrument for automated isola...
Medical Devices·816 affected·Jul 16, 2012
High RiskFDA
Roche Molecular Systems, Inc.
DataInnovations (Instrument Manager) (version 8.04) interfaces middleware between larger Clinical Chemistry / Immunology instrument syst...
Medical Devices·1,015 affected·Jul 16, 2012
High RiskFDA
Animas Corporation
IR1200, IR1250(IR1200 Plus), 2020 and One Touch(R) Ping(R) Insulin Pump glucose management system. The device is intended to deliver i...
Diabetes Devices·236,470 affected·Jul 16, 2012
High RiskFDA
Roche Molecular Systems, Inc.
Data Station AMPLILINK software is an instrument user interface/ data management software used with COBAS¿ AmpliPrep instrument, COBAS¿ T...
Diagnostic Devices·884 affected·Jul 16, 2012
High RiskFDA
Lucero Medical Llc
Enduramesh Corpectomy Spacer System Product Usage: The Enduramesh is a vertebral body replacement system intended for use in the thora...
Medical Devices·169 affected·Jul 15, 2012
High RiskFDA
Smith & Nephew, Inc. Endoscopy Division
Smith & Nephew 5.5 mm Dyonics Bonecutter ,Electroblade Full Radius Part Number: 7205962 Product Usage: The Dyonics Electroblade Re...
Surgical Devices·108 affected·Jul 14, 2012
High RiskFDA
Smith & Nephew, Inc. Endoscopy Division
Smith & Nephew Dyonics Electroblade Resector, 4.5mm Full Radius Blade, BONECUTTER Part Number: 72202213 Product Usage: The Dyonics E...
Surgical Devices·340 affected·Jul 14, 2012
High RiskFDA
Southern Bakeries, Llc
Nature's Grain Garlic French Bread, 10 oz (284 g) packages,
Bakery & Grains·3,736 affected·Jul 13, 2012
High RiskFDA
Authentic Gourmet
Raspberry Filled Cake, 21.9 oz (1lb 6oz) (620g), UPC 3 760147 195881
Bakery & Grains·2,560 affected·Jul 13, 2012
High RiskFDA
Authentic Gourmet
Strawberry Filled Cake, 21.9 oz (1lb 6oz) (620g), UPC 3 760147 195867
Bakery & Grains·2,560 affected·Jul 13, 2012
High RiskFDA
Island Kinetics Dba Covalence
CosMedix Serious Protection, Natural SPF 28 Sunscreen, 3.3 fl.oz/100mL (100 g), Distributed by CosMedix, LLC, Atlanta, GA --- Also labele...
Drugs·5,311 affected·Jul 13, 2012
High RiskFDA
Intuitive Surgical, Inc.
KIT,DISPOSABLE ACCESSORY,3ARM,IS3000,5 PACK; Product Usage: The intended use of the Instrument arm drape is to protect equipment f...
Surgical Devices·92,390 affected·Jul 13, 2012
CriticalFDA
Baxter Healthcare Corp.
AUTOMIX High Speed Compounder System, product 2M8077; automated nutrition compounders; Product Usage: The Automix Compounder Systems...
Medical Devices·270 affected·Jul 13, 2012
High RiskFDA
Intuitive Surgical, Inc.
KIT,DISPOSABLE ACCESSORY,4ARM,IS2000,5 PACK; Product Usage: The intended use of the Instrument arm drape is to protect equipment f...
Surgical Devices·92,390 affected·Jul 13, 2012
CriticalFDA
Baxter Healthcare Corp.
AUTOMIX 3+3 Compounder with Accusource Monitoring System, product 2M8287; automated nutrition compounders; Product Usage: The Automi...
Medical Devices·950 affected·Jul 13, 2012
High RiskFDA
Intuitive Surgical, Inc.
ACCESSORY BASE STARTER KIT,IS3000; Product Usage: The intended use of the Instrument arm drape is to protect equipment from conta...
Surgical Devices·92,390 affected·Jul 13, 2012