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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
High RiskFDA
Intuitive Surgical, Inc.
KIT,DISPOSABLE ACCESSORY,4ARM,IS3000,5 PACK; Product Usage: The intended use of the Instrument arm drape is to protect equipment ...
Surgical Devices·92,390 affected·Jul 13, 2012
CriticalFDA
Baxter Healthcare Corp.
AUTOMIX Plus High Speed Compounder System, product 2M8075; automated nutrition compounders; Product Usage: The Automix Compounder Sy...
Medical Devices·840 affected·Jul 13, 2012
CriticalFDA
Baxter Healthcare Corp.
AUTOMIX 3+3 Compounder System, product 2M8286 (115V) and 2M8286K (230V), automated nutrition compounders; Product Usage: The Automix...
Medical Devices·3,106 affected·Jul 13, 2012
High RiskFDA
Zimmer, Inc.
The NCB Polyaxial Locking Plate System NCB screws 26mm: 02.03155.026, non-sterile Product is implantable screws indicated for temporar...
Medical Implants·24 affected·Jul 13, 2012
Medium RiskCPSC
Retail Stores Including Babies R Us, Burlington Coat Factory, Buy Buy Baby, Shopko And Toys R Us, As Well As Online Outlets Including Albeebaby.com, Amazon.com, Babyage.com, Babysupermart.com, Diapers.com And Target.com From January 2005 Through July 2012 For Between $100 And $150.
Chicco Polly High Chairs Recalled Due to Laceration Hazard
Furniture·455,000 affected·Jul 12, 2012
CriticalCPSC
Family Dollar Stores From September 2011 Through December 2011 For $8.
Family Dollar Stores Recalls Decorative Light Sets Due To Fire and Electrical Shock Hazard
Toys·280,000 affected·Jul 12, 2012
RecallCPSC
The Recalled Stools Were Distributed Free By Various Companies As Promotional Products Between March 2012 And May 2012.
Molenaar Recalls Folding Step Stools Due to Fall Hazard
Tools·3,700 affected·Jul 12, 2012
RecallCPSC
Old Navy Stores In The U.s. And Canada And At Oldnavy.com In The U.s. And At Oldnavy.ca In Canada From February 2012 Through June 2012. The Shoes Sold For Between $12 And $15.
Old Navy Recalls Toddler Girl Aqua Socks Due to Slip and Fall Hazard
Consumer Products·34,000 affected·Jul 12, 2012
High RiskFDA
Pulmuone Wildwood Inc
Wildwood Emerald Valley Kitchen Organic Medium Salsa, 30 oz. Pack size 6/30 oz per case, 14 oz Pack size 6/14oz per case, Packaged i...
Food·61,288 affected·Jul 12, 2012
High RiskFDA
Pulmuone Wildwood Inc
Wildwood Emerald Valley Kitchen Organic Mild Salsa - Canada (containing French in labeling), 397 mL. Pack size 6/14 oz per case. Packaged...
Food·781 affected·Jul 12, 2012
High RiskFDA
Pulmuone Wildwood Inc
Wildwood Organic Mild Salsa , 14 oz, Pack size 6/14 oz per case. Packaged in plastic cup, sealed with film and capped with plastic cap. P...
Food·602 affected·Jul 12, 2012
High RiskFDA
Pulmuone Wildwood Inc
Wildwood Organic Medium Salsa , 14 oz, Pack size 6/14 oz per case. Packaged in plastic cup, sealed with film and capped with plastic cap....
Food·748 affected·Jul 12, 2012
High RiskFDA
Pulmuone Wildwood Inc
Wildwood Emerald Valley Kitchen Organic Hot Salsa, 14 oz. Pack size 6/14 oz per case. Packaged in plastic cup, sealed with film and cappe...
Food·3,148 affected·Jul 12, 2012
High RiskFDA
Noven Pharmaceuticals, Inc.
Daytrana (methylphenidate) transdermal system patch, Delivers 15 mg over 9 hours (1.6 mg/hr), 1 patch per pouch, packaged in 30-count pat...
Topical Drugs·231,270 affected·Jul 12, 2012
High RiskFDA
Noven Pharmaceuticals, Inc.
Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 hours (2.2 mg/hr), 1 patch per pouch, packaged in 30-count pat...
Topical Drugs·177,900 affected·Jul 12, 2012
RecallFDA
Axcentria Pharmaceuticals Llc
Major brand Infants' Mapap, Acetaminophen Concentrated Drops, 1 FL. OZ. (30 mL.) 80 mg. per 0.8 mL, Cherry Flavor, Distributed by MAJOR P...
Drugs·13,128 affected·Jul 12, 2012
High RiskFDA
Noven Pharmaceuticals, Inc.
Daytrana (methylphenidate) transdermal system patch, Delivers 30 mg over 9 hours (3.3 mg/hr), 1 patch per pouch, packaged in 30-count pat...
Topical Drugs·121,530 affected·Jul 12, 2012
CriticalCPSC
Camera, Office Supply And Mass Merchandise Stores, In Catalogs And On Various Websites Nationwide. They Were Sold With The Digital Slr Camera In Canada From February 2012 Through March 2012 And In The U.s. From March 2012 Through April 2012 For Between $1,200 And $3,000.
Nikon Recalls Rechargeable Battery Packs Sold with Digital SLR Cameras Due to Burn Hazard
Batteries & Power·5,100 affected·Jul 11, 2012
Medium RiskCPSC
Walmart, Toys R Us, Academy And At Other Specialty Stores, And Online Retailers From December 2011 Through May 2012 For Between $130 And $280.
Troxel Recalls Flexible Flyer Swing Sets Due to Fall Hazard
Toys·100,500 affected·Jul 11, 2012
High RiskFDA
Kt Specialty Foods Inc.
Veggie Pizza. Label is not provided. Product is packaged and delivered in bulk.
Food·20 affected·Jul 11, 2012
High RiskFDA
Kt Specialty Foods Inc.
Pizza Bagel. Label is not provided. Product is packaged and delivered in bulk.
Food·50 affected·Jul 11, 2012
High RiskFDA
Kt Specialty Foods Inc.
Cheese Pizza. Label is not provided. Product is packaged and delivered in bulk.
Dairy·20 affected·Jul 11, 2012
High RiskFDA
Actavis
Fentanyl Transdermal System, 100 mcg/h, each transdermal system contains: 10 mg fentanyl and 0.4 mL alcohol USP, Rx only, supplied in sin...
Drugs·98,088 affected·Jul 11, 2012
CriticalFDA
Ventlab Corporation
Safe Spot Infant Resuscitator, SS3200 Series, Single Patient Use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27...
Respiratory Devices·14,602 affected·Jul 11, 2012
CriticalFDA
Medtronic Navigation, Inc.
Medtronic O-arm¿ Imaging System. Product Numbers: BI-700-00027-100, BI-700-00027-100R, BI-700-00027-120, BI-700-00027-120R, BI-700-00027...
Medical Devices·17 affected·Jul 11, 2012
CriticalFDA
Ventlab Corporation
AirFlow Resuscitator, Adult Resuscitator, AF1000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC...
Respiratory Devices·14,602 affected·Jul 11, 2012
CriticalFDA
Ventlab Corporation
V*Care Resuscitator Infant Resuscitator, VN 3000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC...
Respiratory Devices·14,602 affected·Jul 11, 2012
CriticalFDA
Ventlab Corporation
Safe Spot Infant Resuscitator, Pro-1900 Series, Single Patient Use, The Disposable Resuscitators with optional built-in pressure mon...
Respiratory Devices·14,602 affected·Jul 11, 2012
CriticalFDA
Ventlab Corporation
Adult Resuscitator, Pro-5000 Series, Single Patient Use, The Disposable Resuscitators with optional built-in pressure monitor is int...
Respiratory Devices·14,602 affected·Jul 11, 2012
CriticalFDA
Ventlab Corporation
Ventlab Rescue Med Infant Resuscitator, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Res...
Respiratory Devices·14,602 affected·Jul 11, 2012
High RiskFDA
Philips Healthcare Inc.
Philips MultiDiagnost Eleva with Flat Detector (MD Eleva FD)Model: 708034 Product Usage: Philips X-ray System
Diagnostic Devices·41 affected·Jul 11, 2012
CriticalFDA
Ventlab Corporation
AirFlow, Infant Resuscitator, AF3000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028 Th...
Respiratory Devices·14,602 affected·Jul 11, 2012
High RiskFDA
Siemens Medical Solutions Usa, Inc.
ACUSON SC2000 ultrasound systems at software versions VA20A or VA20B. Model number 10433816. The SC2000 ultrasound imaging system is ...
Cardiac Devices·476 affected·Jul 11, 2012