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All Product Recalls

49,195 recalls from FDA (high severity)

Source:AllCPSCFDAUSDASeverity:AllCriticalHighMedium
High RiskFDA
Koogee-queen Anne, Llc
Bourbon Ice Cream. Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Dairy·5 affected·Apr 10, 2014
High RiskFDA
The Pastene Companies Ltd.
Pastene ITAL NIDI #81 ,16 oz cellophane bag. Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number:7090 UPC...
Food·6,000 affected·Apr 10, 2014
High RiskFDA
Koogee-queen Anne, Llc
Chocolate Bourbon Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Dairy·2 affected·Apr 10, 2014
High RiskFDA
Koogee-queen Anne, Llc
Watermelon Sorbet, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Beverages·1 affected·Apr 10, 2014
High RiskFDA
Koogee-queen Anne, Llc
Coconut Almond White Chocolate Dream Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisvil...
Dairy·3 affected·Apr 10, 2014
High RiskFDA
Koogee-queen Anne, Llc
Simply Southern Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Dairy·14 affected·Apr 10, 2014
High RiskFDA
Koogee-queen Anne, Llc
Vermont Maple Walnut Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Dairy·13 affected·Apr 10, 2014
High RiskFDA
Koogee-queen Anne, Llc
Georgia Butter Pecan Ice Cream and Simply Southern Ice Cream. Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort...
Dairy·3 affected·Apr 10, 2014
High RiskFDA
Koogee-queen Anne, Llc
Hey Jude Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Dairy·4 affected·Apr 10, 2014
High RiskFDA
Koogee-queen Anne, Llc
Gin and Juice Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Dairy·1 affected·Apr 10, 2014
High RiskFDA
Koogee-queen Anne, Llc
Tiramisu Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Dairy·1 affected·Apr 10, 2014
High RiskFDA
Koogee-queen Anne, Llc
Pistachio Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Dairy·1 affected·Apr 10, 2014
High RiskFDA
Bausch & Lomb, Inc.
Sodium Chloride Hypertonicity Ophthalmic Ointment, 5%, 1/8 oz. (3.5 g) tube per carton, Distributed by Major Pharmaceuticals, 31778 Enter...
Topical Drugs·35,253 affected·Apr 10, 2014
High RiskFDA
Bausch & Lomb, Inc.
Muro 128 (sodium chloride) hypertonicity ophthalmic ointment, 5%, packaged in a) 1 g tube per carton, professional sample, NDC 24208-385-...
Topical Drugs·4,165 affected·Apr 10, 2014
High RiskFDA
Wockhardt Usa Inc.
Metoprolol Succinate Extended-Release Tablets, USP, 100 mg, 100-count bottle, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India;...
Oral Drugs·8,712 affected·Apr 10, 2014
High RiskFDA
Ortho-clinical Diagnostics
VITROS 5,1 FS Chemistry System and VITROS 5,1 FS Refurbished, Product Codes/Catalog Numbers 6801375, 6801890 for in vitro diagnostic use.
Diagnostic Devices·597 affected·Apr 10, 2014
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Systems VitD Total 100 test, Ready Pack, For OUS; SMN 10699201. Intended for the invitro diagnostic use in quantitativ...
Diagnostic Devices·40,266 affected·Apr 10, 2014
High RiskFDA
Ortho-clinical Diagnostics
enGen Laboratory Automation Systems (enGen) with TCAutomation -- For in vitro quantitative measurement of a variety of analytes of clin...
Diagnostic Devices·31 affected·Apr 10, 2014
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Systems VitD 500 test, Ready Pack, Catalog Number: 10631021. Intended for the invitro diagnostic use in quantitative ...
Diagnostic Devices·12,787 affected·Apr 10, 2014
High RiskFDA
Ortho-clinical Diagnostics
VITROS 5600 Integrated System, Product Code/Catalog Number 6802413 for in vitro diagnostic use.
Diagnostic Devices·835 affected·Apr 10, 2014
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Systems TSH3 Ultra , Ready Pack, 500 test Catalog Number: 06491080; Siemens Material Number: 10282379. Intended for the...
Diagnostic Devices·155,345 affected·Apr 10, 2014
High RiskFDA
Ortho-clinical Diagnostics
VITROS 4600 Chemistry System, Product Code/Catalog Number 6802445 for in vitro diagnostic use.
Diagnostic Devices·82 affected·Apr 10, 2014
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Systems BRAHMS PCT 100 test Sold only OUS; Catalog Number: 10378883.
Medical Devices·16,302 affected·Apr 10, 2014
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Systems TSH3 Ultra Ready Pack, 100 test Catalog Number: 06491072; Siemens Material Number: 10282378. Intended for the ...
Diagnostic Devices·22,770 affected·Apr 10, 2014
High RiskFDA
Synthes, Inc.
Synthes External Fixation Systems (Small, Medium, Large and DO), bone fixation appliance components.
Medical Devices·5,114,052 affected·Apr 10, 2014
High RiskFDA
Legacy Pharmaceutical Packaging
Pantoprazole Sodium, Delayed-release tablets, USP, 40 mg tablets, 100 (10x10) unit dose packages, Manufactured by Dr. Reddy's Laboratorie...
Oral Drugs·0 affected·Apr 9, 2014
High RiskFDA
Caraco Pharmaceutical Laboratories, Ltd.
Gemcitabine For Injection USP, 1 g, (lyophilized), For Intravenous Use Only, Sterile Single Use Vial, Rx only, Manufactured by: Sun Pharm...
Injectable Drugs·200 affected·Apr 9, 2014
High RiskFDA
Edwards Lifesciences, Llc
Edwards Lifesciences Fem-Flex II Arterial and femoral Cannulae, arterial cannula sizes 16, 18 and 20 French, models: FEMII016A, FEMII01...
Medical Devices·13,115 affected·Apr 9, 2014
High RiskFDA
Ev3, Inc.
ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 120mm x 135cm, REF: AB35W06120135. and ev3 EverCross 0.035" OTW PTA Dilatatio...
Surgical Devices·39 affected·Apr 9, 2014
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, NeuroMuscular Transmission Module, E-NMT-01 Product Usage: The Datex-Ohmeda S/5TM E-NMT module is indicated for monito...
Medical Devices·1,794 affected·Apr 9, 2014
High RiskFDA
Pfizer Inc.
Tikosyn¿ (dofetilide) 500 mcg (0.5mg) capsules, 60-count bottle, Rx only Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, NDC 00069-58...
Oral Drugs·23,064 affected·Apr 8, 2014
High RiskFDA
Siemens Medical Solutions Usa, Inc.
e.cam -emission computed tomography system Used to detect or image the distribution of radionuclides in the body or organ, using the f...
Medical Devices·4,462 affected·Apr 8, 2014
High RiskFDA
Synthes, Inc.
Synthes XRL Medium Trial - Central Body, an instrument used as part of the Synthes XRL System, a vertebral body replacement device. For...
Medical Devices·3 affected·Apr 8, 2014
High RiskFDA
Beckman Coulter, Inc.
MicroScan Pos Combo Panel Type 33 (PC33): Catalog number B1017-211 MicroScan Pos Combo 33 B1017-211 panels are designed for use in d...
Medical Devices·664 affected·Apr 8, 2014
High RiskFDA
Bio-rad Laboratories, Inc.
Variant II beta-thalassemia Short Program Model Numbers 270-2103 (250 tests) and 270-2154 (500 tests), Bio-Rad Laboratories, Inc. in vit...
Diagnostic Devices·457 affected·Apr 8, 2014
High RiskFDA
Philips Medical Systems, Inc.
Intended for both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, ...
Diagnostic Devices·247 affected·Apr 8, 2014
High RiskFDA
Piramal Critical Care, Inc.
Sevoflurane, USP (Inhalation Anesthetic), Rx Only, 250 mL Amber Bottle. Manufactured By: Piramal Critical Care, 3950 Schelden Circle, Bet...
Drugs·12,600 affected·Apr 7, 2014
High RiskFDA
Teva Pharmaceuticals Usa
BUPRENORPHINE HYDROCHLORIDE Sublingual Tablets, 8 mg, 30-count bottles, Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 00...
Oral Drugs·53,452 affected·Apr 7, 2014
High RiskFDA
Teva Pharmaceuticals Usa
BUPRENORPHINE HYDROCHLORIDE Sublingual Tablets, 2 mg, 30-count bottles, Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 00...
Oral Drugs·17,181 affected·Apr 7, 2014
High RiskFDA
Small Bone Innovations, Inc.
SBi RingFix Olive Wires Product Usage: These are temporary devices indicated for: osteosynthesis of fractures with small osteoarticul...
Medical Devices·44 affected·Apr 7, 2014
High RiskFDA
Western / Scott Fetzer Company
Model RG3000 and RG4000 Series Valve Integrated Pressure Regulator (VIPR)
Medical Devices·118,325 affected·Apr 7, 2014
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, CardiacVX [CardiacVX (1.1.0 Ext. d) and CardiacVX Flow (1.1.0 Ext. d) analysis software running on Advantage Workstation]....
Cardiac Devices·101 affected·Apr 7, 2014
High RiskFDA
Jas Diagnostics Inc.
Glucose Hexokinase Liquid Reagent For the in vitro quantitative determination of Glucose in serum.
Diabetes Devices·407 affected·Apr 7, 2014
High RiskFDA
Whole Foods Market
The Kitchen Whole Foods Chipotle Chicken Wrap; Good to Go. Net Weight: 10 oz.. (283 g) individually wrapped sandwich wraps. Distrib...
Meat & Poultry·229 affected·Apr 4, 2014
High RiskFDA
Medtronic Neuromodulation
Refill Kit 8551/856X (includes Models 8561, 8562 and 8564) for use with Medtronic Implantable Programmable Infusion Pumps. Product Usa...
Medical Implants·13,784 affected·Apr 4, 2014
High RiskFDA
Smith & Nephew Inc
TRIGEN INTERTAN NAIL: (1) REF 71675201, 10 MM X 18 CM, 125 degree, (2) REF 71675202, 11.5 MM X 18 CM, 125 degree, (3) REF 71675203,...
Medical Devices·1,253 affected·Apr 4, 2014
High RiskFDA
Smith & Nephew Inc
TRIGEN INTERTAN 1.5 NAIL: (1) REF 71676515, 10 MM X 10 CM, 125 degree, LEFT, (2) REF 71676556, 11.5 MM X 36 CM, 125 degree, RIGHT, ...
Medical Devices·1,253 affected·Apr 4, 2014
High RiskFDA
Steris Corporation
Vertical Spring Arm for Single or Dual Monitor Mount (Harmony LL 500 and Harmony LL 700 surgical lighting systems), Steris Corporation. ...
Surgical Devices·68 affected·Apr 4, 2014