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High RiskFDA
Instrumentation Laboratory Co.
ACL TOP 700; PN 0000280010 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical u...
Diagnostic Devices·311 affected·Jul 19, 2013
High RiskFDA
Blue Belt Technologies Mn
Blue Belt Technologies, Inc. Monitor Drape REF: PFSD-V0001, Rx only, Sterile EO. Product Usage: The intended use of this device ...
Medical Devices·60 affected·Jul 19, 2013
High RiskFDA
Atrium Medical Corporation
C-QUR V-Patch Mesh (All sizes and shapes). Intended for use in soft tissue deficiencies.
Medical Devices·95,286 affected·Jul 19, 2013
High RiskFDA
Atrium Medical Corporation
C-QUR Mesh (All Sizes, shapes). Intended for use in soft tissue deficiencies.
Medical Devices·32,834 affected·Jul 19, 2013
High RiskFDA
Micro Therapeutics Inc, Dba Ev3 Neurovascular
Pipeline Embolization Device (PED) The Pipeline Embolization Device is indicated for the endovascular treatment of adults (22 years of...
Medical Devices·62 affected·Jul 19, 2013
High RiskFDA
Instrumentation Laboratory Co.
ACL TOP CTS; PN 0000280020 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical u...
Diagnostic Devices·486 affected·Jul 19, 2013
RecallCPSC
Macy's Stores Nationwide, On The Firm's Website Www.macys.com, And At Military Exchanges Between September And November 2012 For Between $25 And $52.
Macy's Recalls Infants' First Impressions Varsity Jackets Due to Choking Hazard
Children's Products·8,700 affected·Jul 18, 2013
CriticalCPSC
Bass Pro Shops And Cabelas Stores Nationwide From May 2012 Through August 2012 For Between $270 And $430.
Masterbuilt Manufacturing Recalls Electric Smokers Due to Fire Hazard
Outdoor & Garden·11,000 affected·Jul 18, 2013
CriticalFDA
Ferrara Candy Company
Chocolate malted milk balls packaged in 6 lbs. bags and each case contains 3 x 6 lbs. bags; BEST BY 04/17/14; BRCH CHOC
Dairy·293 affected·Jul 18, 2013
High RiskFDA
Olam Tomato Processors, Inc.
Medium Chunky Salsa, a Home Style Select brand, in 16oz glass jars, UPC: 3927759139; Product is distributed by Dollar Tree; Product is p...
Produce·12,870 affected·Jul 18, 2013
RecallFDA
Vi-jon, Inc.
ALCOHOL FREE ANTISEPTIC (cetylpyridinium chloride) Mouth Rinse, 0.07%, mint, 33.8 FL OZ (1 L) bottle, Distributed By The Kroger Co., Cinc...
Drugs·18,408 affected·Jul 18, 2013
Medium RiskFDA
Glaxosmithkline, Llc.
TUMS, Antacid/Calcium Supplement, ULTRA Strength 1000, Assorted Berries, 72 Chewable Tablets, GlaxoSmithKline, Moon Twp, PA 15108, NDC 0...
Oral Drugs·300,480 affected·Jul 18, 2013
High RiskFDA
Siemens Medical Solutions Usa, Inc
PRIMUS, ONCOR, ARTISTE Linac systems with component Tabletop, 550TxT, TT-A s/n 1001-1233 and Tabletop 550TxT, TT-S s/n 1001-1083. Pr...
Medical Devices·179 affected·Jul 18, 2013
High RiskFDA
Vital Signs Devices, A Ge Healthcare Company
Disposable Temperature Probes, (sterile), Sensor diameter: 3mm/0.12 in; 25 units per box. Vital Signs Inc. a GE Healthcare Company, 20 Ca...
Medical Devices·12,239 affected·Jul 18, 2013
RecallCPSC
A&e Stores, All Kids Inc 27, Bergen Kids Llc, Children's Town, Cititrends Inc., Concord Stores, Fordham Kids, Hudson Operating Corp, Kiddie Outlet, Modecraft/burlington, Myrtle Kids, Pitkin Kids, Suitmart And Youngland From August 2010 Through March 2011 For About $30.
Boys’ Hooded Jackets Recalled by 5 Star Kids Apparel Due to Strangulation Hazard
Clothing & Apparel·48,000 affected·Jul 17, 2013
CriticalCPSC
Rei Stores Nationwide And Online From April To May 2013 For About $70.
Industrial Revolution Recalls LED Lanterns Due to Fire Hazard; Sold Exclusively at REI Stores
Batteries & Power·2,300 affected·Jul 17, 2013
CriticalCPSC
Sears And Kmart Stores Nationwide And Sears.com And Kmart.com From 2003 To 2009 For Between $140 And $220.
Sears Reannounces Recall of Kenmore Dehumidifiers Due to Additional Reports of Fires, Burn, Low Consumer Response Rate
Consumer Products·795,000 affected·Jul 17, 2013
RecallCPSC
Amazon.com From June 2012 Through January 2013 For About $35.
Thermobaby Bath Seats Recalled by SCS Direct Due to Drowning Hazard; Sold Exclusively at Amazon.com
Children's Products·7,500 affected·Jul 17, 2013
High RiskFDA
Mike's Quality Meats, Inc.
Frozen Hot Smoked Vacuum Packed Salmon
Seafood·65 affected·Jul 17, 2013
High RiskFDA
Apotex Inc.
Acyclovir Tablets USP 800 mg ,(NDC 60505-5307-1), Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured f...
Oral Drugs·4,844 affected·Jul 17, 2013
High RiskFDA
Medtronic Inc. Cardiac Rhythm Disease Management
Medtronic Custom Perfusion System with Carmeda BioActive Surface. Model Numbers: CB1D82R12 and CB5N73R7. Sterilized by Ethylene Oxid...
Medical Devices·217 affected·Jul 17, 2013
High RiskFDA
Integra Limited
Integra Leyla Ball Joint Clamp, also as included in Leyla Table Mounting Hardware. The Leyla Retraction System, as part of the Ruggle...
Medical Devices·65 affected·Jul 17, 2013
High RiskFDA
Medtronic Inc. Cardiac Rhythm Disease Management
Medtronic Custom Perfusion System. Model Numbers: 1D80R8, 1E34R1, 1F75R1, 1G49R2, 1G75R1, 1P07R8, 1P91R4, 5B15R11, and 5P51R9. Steri...
Medical Devices·13,223 affected·Jul 17, 2013
High RiskFDA
Medtronic Inc. Cardiac Rhythm Disease Management
Medtronic Custom Perfusion System with Trillium BioSurface (a polymer containing non-leaching heparin). Model Numbers: TL4X17R8, TL5D01...
Medical Devices·758 affected·Jul 17, 2013
High RiskFDA
Arrow International Inc
Arrowgard Blue and Arrowgard Blue Plus Pressure Injectable Central Venous Catheter, a multiple-lumen catheter that permits venous access ...
Surgical Devices·4,285 affected·Jul 17, 2013
High RiskFDA
Hospira Inc.
Product is labeled in part: LIST NO. 43449; RECEPTAL CANISTER; DO NOT FILL 900 ABOVE THIS LINE; Product of China; Hospira, Inc.,; Lake Fo...
Medical Devices·3,560 affected·Jul 17, 2013
High RiskFDA
Beckman Coulter Inc.
Hemoccult ICT (Immunochemical Fecal Occult Blood Test) is a rapid, visually read, qualitative immunochemical chromatographic method for d...
Medical Devices·68,116 affected·Jul 17, 2013
High RiskFDA
Arrow International Inc
Arrowgard Blue Plus Antimicrobial Multi-lumen Central Venous Catheter, catalogue number AK-45854-CDC.
Surgical Devices·170 affected·Jul 17, 2013
RecallFDA
Craft Brewers Alliance Inc.
Square Mile Spur & Vine Hopped Apple Cider is hopped hard cider is in liquid form and is an alcoholic beverage. It is packaged in 22 fl ...
Beverages·2,699 affected·Jul 16, 2013
RecallFDA
Craft Brewers Alliance Inc.
Square Mile Original Hard Apple Cider is hard cider is in liquid form and is an alcoholic beverage. It is packaged in 22 fl oz glass bott...
Beverages·3,053 affected·Jul 16, 2013
CriticalFDA
Whole Foods Market Mid-atlantic Kitchen
Pimento Cheese, packaged in 7 oz. plastic containers, and labeled in part ***Made by Whole Foods Market, Landover, MD 20785***UPC: 000000...
Dairy·624 affected·Jul 16, 2013
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance iCT and Brilliance iCT SP These systems are intended to produce cross-sectional images of the body by computer reconstructi...
Medical Devices·506 affected·Jul 16, 2013
High RiskFDA
Aesculap, Inc.
UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.
Surgical Devices·217 affected·Jul 16, 2013
High RiskFDA
Waldemar Link Gmbh & Co. Kg (corp. Hq.)
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/20, Stem size S-4, prox. Stem dia. 20 mm, Length 180 mm, WALDEMAR LINK GmbH & ...
Medical Devices·8 affected·Jul 16, 2013
High RiskFDA
Assuramed
DiaScreen Liquid Urine Controls: Positive and Negative Assayed Liquid Quality Controls for use with Dipsticks in Routine Urinalysis; Prod...
Diagnostic Devices·10 affected·Jul 16, 2013
High RiskFDA
Waldemar Link Gmbh & Co. Kg (corp. Hq.)
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/14, Stem size S-1, prox. Stem dia. 14 mm, Length 180 mm, WALDEMAR LINK GmbH & ...
Medical Devices·6 affected·Jul 16, 2013
RecallFDA
Zoll Circulation, Inc.
Zoll Circulation LifeBand Single Pack (accessory), and Nickel-metal hydride (NIMH) Battery. The LifeBand is a chest compression assembl...
Medical Devices·161 affected·Jul 16, 2013
High RiskFDA
Assuramed
ProTime Microcoagulation System; PROTIME CUVETTE AND PROTIME3 CUVETTE; Store the foil-pouched cuvettes refrigerated 2-8C (36 - 36F); MATE...
Diagnostic Devices·1 affected·Jul 16, 2013
High RiskFDA
Waldemar Link Gmbh & Co. Kg (corp. Hq.)
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/14, Stem size 01, prox. Stem dia. 14 mm, Length 250 mm, WALDEMAR LINK GmbH & C...
Medical Devices·7 affected·Jul 16, 2013
High RiskFDA
Hemocue Ab
HemoCue¿ Urine Albumin Microcuvettes, 25 Microcuvettes HemoCue AB Angelholm, Sweden The quantitative, rapid, turbidimetric immunoassay...
Diagnostic Devices·10,356 affected·Jul 16, 2013
High RiskFDA
Waldemar Link Gmbh & Co. Kg (corp. Hq.)
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/22, Stem size 05, prox. Stem dia. 22.5 mm, Length 250 mm, WALDEMAR LINK GmbH &...
Medical Devices·4 affected·Jul 16, 2013
High RiskFDA
Waldemar Link Gmbh & Co. Kg (corp. Hq.)
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/14, Stem size 001, prox. Stem dia. 14 mm, Length 210 mm, WALDEMAR LINK GmbH & ...
Medical Devices·5 affected·Jul 16, 2013
High RiskFDA
Waldemar Link Gmbh & Co. Kg (corp. Hq.)
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/16, Stem size 002, prox. Stem dia. 16 mm, Length 210 mm, WALDEMAR LINK GmbH & ...
Medical Devices·6 affected·Jul 16, 2013
High RiskFDA
Waldemar Link Gmbh & Co. Kg (corp. Hq.)
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/25, Stem size S-6, prox. Stem dia. 25 mm, Length 180 mm, WALDEMAR LINK GmbH & ...
Medical Devices·8 affected·Jul 16, 2013
High RiskFDA
Waldemar Link Gmbh & Co. Kg (corp. Hq.)
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/16, Stem size S-2, prox. Stem dia. 16 mm, Length 180 mm, WALDEMAR LINK GmbH & ...
Medical Devices·6 affected·Jul 16, 2013
High RiskFDA
Waldemar Link Gmbh & Co. Kg (corp. Hq.)
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/25, Stem size 006, prox. Stem dia. 25 mm, Length 210 mm, WALDEMAR LINK GmbH & ...
Medical Devices·5 affected·Jul 16, 2013
High RiskFDA
Waldemar Link Gmbh & Co. Kg (corp. Hq.)
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/25, Stem size 06, prox. Stem dia. 25 mm, Length 250 mm, WALDEMAR LINK GmbH & C...
Medical Devices·5 affected·Jul 16, 2013
High RiskFDA
Zimmer, Inc.
Moore Hip Prosthesis Long Fenestrated Stem, several head Diameter, 203 mm Stem length. Used to seat the prosthesis with or without bon...
Medical Implants·1,710 affected·Jul 16, 2013