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High RiskFDA
Biomet Spine, Llc
Anchored Lateral Retractable Drill, Timberline IPF IFU IFU8621-0113, Model 8630-0102. Timberline Anchored Lateral Retractable Drills ...
Medical Devices·15 affected·Aug 22, 2013
RecallCPSC
Babies R Us And Www.babiesrus.com From December 2011 Through July 2013 For About $25.
HALO SleepSacks Wearable Blankets Recalled Due to Choking Hazard; Sold Exclusively at Babies R Us
Children's Products·27,000 affected·Aug 21, 2013
CriticalFDA
Tampa Maid Foods, Inc.
Frozen, 4/3 lb unlabeled bags contained in a master carton box labeled in part: "Portico Brand 4/3 lb 170585 Breaded Scallops***Net Wt 1...
Bakery & Grains·142 affected·Aug 21, 2013
Medium RiskFDA
Actavis South Atlantic Llc
buPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, 30-count tablets per bottle, Rx only, Distributed by: Actavis South Atlant...
Oral Drugs·428,268 affected·Aug 21, 2013
CriticalFDA
Siemens Healthcare Diagnostics, Inc.
Microscan Synergies Plus Negative Urine Combo 5 Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Nega...
Medical Devices·522 affected·Aug 21, 2013
CriticalFDA
Siemens Healthcare Diagnostics, Inc.
Microscan Synergies Plus Negative Urine Combo 2 Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negati...
Medical Devices·1,324 affected·Aug 21, 2013
CriticalFDA
Siemens Healthcare Diagnostics, Inc.
Microscan Synergies Plus Negative Breakpoint Combo 7 Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (N...
Medical Devices·4,319 affected·Aug 21, 2013
CriticalFDA
Siemens Healthcare Diagnostics, Inc.
MicroscanrapID/S panels NC3.11 Sold in Japan only. Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus ...
Medical Devices·57,600 affected·Aug 21, 2013
CriticalFDA
Siemens Healthcare Diagnostics, Inc.
Microscan plus Negative Breakpoint Combo 4 Sold outside of US only. Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroSc...
Medical Devices·57,600 affected·Aug 21, 2013
CriticalFDA
Siemens Healthcare Diagnostics, Inc.
Microscan plus Negative Urine Combo 4 Sold outside of US only. Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ R...
Medical Devices·57,600 affected·Aug 21, 2013
CriticalFDA
Siemens Healthcare Diagnostics, Inc.
Microscan Synergies Plus Negative Combo 2 Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) -...
Medical Devices·2,158 affected·Aug 21, 2013
High RiskFDA
Aso, Llc
SHOPKO Waterproof Adhesive Pads Antibacterial. Used for covering minor cuts, scrapes and burns.
Medical Devices·37 affected·Aug 21, 2013
CriticalFDA
Siemens Healthcare Diagnostics, Inc.
Microscan Synergies Plus Negative Urine Combo 1 Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negati...
Medical Devices·1,209 affected·Aug 21, 2013
CriticalFDA
Siemens Healthcare Diagnostics, Inc.
Microscan rapID/S panels NC3.12 Sold in Japan only. Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus...
Medical Devices·57,600 affected·Aug 21, 2013
CriticalFDA
Siemens Healthcare Diagnostics, Inc.
Microscan plus Negative Combo 3 Sold outside of US only. Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids ...
Medical Devices·57,600 affected·Aug 21, 2013
CriticalCPSC
Boutiques, Children's Specialty Stores Nationwide And Online At Amazon.com,
Apple Park Recalls Children’s Loungewear Due to Violation of Federal Flammability Standard
Children's Products·7,250 affected·Aug 20, 2013
CriticalCPSC
Children's Boutiques And Specialty Stores Nationwide From September 2012 Through March 2013 For Between $32 And $82.
Children’s Pajamas Recalled by Klever Kids Due to Violation of Federal Flammability Standard
Children's Products·7,000 affected·Aug 20, 2013
CriticalCPSC
Target Stores Nationwide And Online At Target.com From January 2006 Through May 2013 For About $9.
Wilton Industries Recalls Chefmate Tea Kettles Due to Burn Hazard; Sold Exclusively at Target
Kitchenware·716,000 affected·Aug 20, 2013
CriticalFDA
Hartleys Potato Chip Company Inc
Hartley's Potato Chips Salt & Vinegar 4.5 oz and 2.5 oz bags Hartley's Potato Chip Co., Inc, Lewistown, PA Ingredients: potatoes, ve...
Snacks & Candy·4,549 affected·Aug 20, 2013
High RiskFDA
Lucy's Kitchen, Inc.
"***SUPERBUDIN"
Food·150 affected·Aug 20, 2013
High RiskFDA
Lucy's Kitchen, Inc.
"***SUPERPAN***Tu Pan Natural***"
Food·6,985 affected·Aug 20, 2013
High RiskFDA
Industrias Alimenticias Kern's Y Cia. S.c.a.
Ducal Brand Prepared Sauce Queso/Cheese, UPC 088313-08328-6, Net Wt 4 oz, Product of Guatemala, C.A. Central American product made with q...
Dairy·84 affected·Aug 20, 2013
High RiskFDA
Mothers Milk Bank
Human breast milk, pasteurized, 4 oz, in bottles; Pasteurized Human Milk,Hospital Grade Milk. Mother's Milk Bank 751 S. Bascom Abe.S...
Dairy·70 affected·Aug 20, 2013
High RiskFDA
Carestream Health Inc.
Carestream DRX Evolution System (Standard Q) The DRX-Evolution System (Standard Q) is a permanently installed diagnostic x-ray system ...
Diagnostic Devices·4 affected·Aug 20, 2013
High RiskFDA
Iba Dosimetry Gmbh
iba COMPASS SW Version 3.0, Catalog Number CS10-100 (medical linear accelerator) radiological
Medical Devices·33 affected·Aug 20, 2013
RecallFDA
Bio-rad Laboratories
FSE Image Upgrade Kit, Catalog # 92019C This kit is used to install and/or upgrade software used with the EVOLIS Microplate System.
Medical Devices·23 affected·Aug 20, 2013
CriticalFDA
G. Debbas Chocolatier, Inc.
Professor Zim Zam's Extraordinary Sweets; Dark Chocolate with Sea Salt; All Natural, 55% Cocoa; Net Wt. 0.35 oz (9.9g) Go Picnic: ...
Snacks & Candy·162,708 affected·Aug 19, 2013
CriticalFDA
G. Debbas Chocolatier, Inc.
Professor Zim Zam's Extraordinary Sweets; Dark Chocolate with Orange; All Natural, 55% Cocoa; Net Wt. 0.35 oz (9.9g) Go Picnic: Di...
Snacks & Candy·126,600 affected·Aug 19, 2013
CriticalFDA
G. Debbas Chocolatier, Inc.
Professor Zim Zam's Extraordinary Sweets; Dark Chocolate with Rice Crisps; All Natural, 55% Cocoa; Net Wt. 0.35 oz (9.9g) Go Picnic...
Snacks & Candy·107,500 affected·Aug 19, 2013
High RiskFDA
Roche Diagnostics Operations, Inc.
ACCU-CHECK FastClix Lancing Device. It is intended for use in conjunction with a blood glucose monitoring system.
Diabetes Devices·36,332 affected·Aug 19, 2013
High RiskFDA
Lumenis, Inc.
Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053. Intended for use in the treatment of ocular pathology.
Medical Devices·3 affected·Aug 19, 2013
CriticalFDA
See's Candies Inc.
See's Candies, Van Doren Dark Chocolate Blueberries; 8 oz. clear plastic packages. See's Candies Inc./See's Candy Shops Inc: South S...
Snacks & Candy·8,327 affected·Aug 17, 2013
High RiskFDA
Amneal Pharmaceuticals Of New York, Llc.
Extended Phenytoin Sodium Capsules, USP, 100 mg, 1000 CAPSULES, Rx only, amneal PHARMACEUTICALS label, NDC 65162-212-11 --- Manufactured ...
Oral Drugs·895 affected·Aug 17, 2013
RecallFDA
Atlantic Pro Nutrients, Inc. Dba Xymogen
LipiChol 540 (Omega-3 Phospholipid) Medical Food Dispense by Prescription Distributed by: PharmaceutiX Orlando, Florida
Food·25,852 affected·Aug 16, 2013
RecallFDA
Justin's Nut Butter
Chocolate Hazelnut Butter 16oz Jar (Unit UPC 894455000490, Case UPC 894455000612)
Dairy·1,512 affected·Aug 16, 2013
High RiskFDA
Jean's Cake
Coffee Cake: queso/manzana (cheese/apple)
Dairy·0 affected·Aug 16, 2013
High RiskFDA
Jean's Cake
Coffee Cake: queso crema (creme cheese)
Dairy·0 affected·Aug 16, 2013
RecallFDA
Justin's Nut Butter
Maple Almond Butter 16 oz Jar (Unit USPC 894455000322, Case USPC 894455002135)
Dairy·5,649 affected·Aug 16, 2013
High RiskFDA
Jean's Cake
Coffee Cake: queso/guava (cheese/guava)
Dairy·550 affected·Aug 16, 2013
High RiskFDA
Jean's Cake
Coffee Cake: queso/fresa (cheese/strawberry)
Dairy·0 affected·Aug 16, 2013
High RiskFDA
Hospira Inc.
Diazepam Injection, USP, 5 mg/mL, 10 mL, Multiple-dose Sterile Non-pyrogenic, Fliptop Vial, C-IV, Rx Only, Hospira, Inc., Lake Forest, IL...
Injectable Drugs·72,300 affected·Aug 16, 2013
High RiskFDA
Covidien Llc
Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 3 mL Fill Product ID: 8881580123 Product Usage: Both 0.9% Sodium Chlorid...
Medical Devices·0 affected·Aug 16, 2013
High RiskFDA
Zeppessis Reprocessing, Llc
Zeppessis' reprocessed single-use manifolds (filters) for the Stryker Neptune 1 and Neptune 2 Waste Management Systems: The Neptune Wa...
Surgical Devices·0 affected·Aug 16, 2013
High RiskFDA
Covidien Llc
Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 10 mL Fill Product ID: 8881570121 Product Usage: Both 0.9% Sodium Ch...
Medical Devices·3,235,860 affected·Aug 16, 2013
High RiskFDA
Covidien Llc
Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 5 mL Fill Product ID: 8881590125 Product Usage: Both 0.9% Sodium Chlo...
Medical Devices·330,120 affected·Aug 16, 2013
High RiskFDA
Covidien Llc
Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 3 mL Fill Product ID: 8881590123 Product Usage: Both 0.9% Sodium Chlori...
Medical Devices·0 affected·Aug 16, 2013
High RiskFDA
Siemens Medical Solutions Usa, Inc.
Symbia S, Product Usage 1) SPECT: To Detect or image the distribution of radionuclides in the body or organ, using the following techn...
Medical Devices·732 affected·Aug 16, 2013
High RiskFDA
Access Scientific Inc
POWERWAND Safety Introducer with Extended Dwell Catheter; Catalog no. 92006. Used to gain access to the vascular system to sample blo...
Surgical Devices·160 affected·Aug 16, 2013