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High RiskFDA
Stanley Security Solutions Inc
Arial Wireless Water-Resistant Call Pendant The Arial Pendant tag is part of the Arial wireless emergency call management system. It en...
Medical Devices·500 affected·Jun 22, 2016
High RiskFDA
Sorin Group Usa, Inc.
AORTIC ARCH CANNULA, Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (part numbers NA-55X7 and NA-55X8) Aortic Arch Can...
Surgical Devices·5,740 affected·Jun 22, 2016
High RiskFDA
Olympus Scientific Solutions Americas
Olympus Scientific Solutions Americas Corporation (OSSA) Model: Analytical X-Ray System X -Ray Fluorescence. Intended to emit ioniz...
Medical Devices·2 affected·Jun 22, 2016
High RiskFDA
Lemaitre Vascular, Inc.
AnastoCiip Universal Clip Remover (6 Pack} REF# 4001-00 The Anastoclip Clip applier consists of a rotating shaft and an integral ca...
Medical Devices·40 affected·Jun 22, 2016
High RiskFDA
Lemaitre Vascular, Inc.
Anastoclip AC 8cm 35 Clips (1 Each} Medium REF # 4000-06 The Anastoclip Clip applier consists of a rotating shaft and an integral car...
Medical Devices·256 affected·Jun 22, 2016
High RiskFDA
Nobel Biocare Usa Llc
Replace Select Tapered TiU NP 3.5x11.5mm, Article No. 36105 Replace Select Tapered implants are root-form endosseous implants intended t...
Medical Implants·53 affected·Jun 22, 2016
High RiskFDA
Kill Cliff
KC (Kill Cliff) Strawberries & Cream Protein Bars, 2.1oz (60g) individually wrapped bar (in cases of 12-2.1 oz (60g) bars).
Dairy·43,788 affected·Jun 21, 2016
High RiskFDA
Omega Medical Imaging, Inc.
2 over 2 Elevating Monitor Suspension - Omega Medical Imaging, LLC Elevating Monitor Suspension Systems.
Medical Devices·26 affected·Jun 21, 2016
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance iCT model #728306; Intended to produce cross- sectional images of the body.
Medical Devices·1 affected·Jun 21, 2016
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance CT Big Bore Oncology, model #728243; Intended to produce cross- sectional images of the body.
Medical Devices·3 affected·Jun 21, 2016
High RiskFDA
Invacare Corporation
Invacare Precise Rx Pediatric Flowmeter Model Number: IRCPF16 AW. Packed one per carton. The lnvacare Precise Rx" Pediatric Flowmeter ad...
Respiratory Devices·395 affected·Jun 21, 2016
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity Core 128, model #728323; Intended to produce cross- sectional images of the body.
Medical Devices·14 affected·Jun 21, 2016
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity Core, model # 728326; Intended to produce cross- sectional images of the body.
Medical Devices·1 affected·Jun 21, 2016
High RiskFDA
The Father's Table, Llc
GFS Brownie Cheesecake, 54 oz, 12 cut with papers. Manufactured by The Fathers Table and Distributed by Gordon Food Service.
Dairy·156 affected·Jun 20, 2016
High RiskFDA
The Father's Table, Llc
GFS Triple White Chocolate Cheesecake, 68 oz, 14 cut with papers. Manufactured by The Fathers Table and Distributed by Gordon Food Service.
Dairy·413 affected·Jun 20, 2016
High RiskFDA
The Father's Table, Llc
GFS Creamy Indulgence NY Style Cheesecake, 68 oz, 12 cut with papers. Manufactured by The Fathers Table and Distributed by Gordon Food S...
Dairy·959 affected·Jun 20, 2016
High RiskFDA
The Father's Table, Llc
GFS Sea Salt Caramel Cheesecake, 68 oz, 14 cut with papers. Manufactured by The Fathers Table and Distributed by Gordon Food Service.
Dairy·76 affected·Jun 20, 2016
High RiskFDA
The Father's Table, Llc
GFS Fruit Swirl Variety Cheesecake, 68 oz, 12 cut. Manufactured by The Fathers Table and Distributed by Gordon Food Service.
Dairy·63 affected·Jun 20, 2016
High RiskFDA
W & C Dba The Apothecary
Calcium Gluconate 1% -- 1000 mL VIAFLEX IV BAG, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sartell, MN 56377
Injectable Drugs·40,000 affected·Jun 20, 2016
High RiskFDA
W & C Dba The Apothecary
Calcium Gluconate 2.5% -- 20 mL PLASTIC SYRINGE, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sartell, MN 56377
Drugs·840 affected·Jun 20, 2016
High RiskFDA
W & C Dba The Apothecary
Papaverine 75 mg / Phentolamine 2.5 mg / Prostaglandin 25 mcg -- 4.2 mL GLASS VIAL, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165...
Drugs·600 affected·Jun 20, 2016
High RiskFDA
W & C Dba The Apothecary
Papaverine 30 mg / Phentolamine 1 mg / mL -- 5 mL GLASS VIAL, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sa...
Drugs·450 affected·Jun 20, 2016
High RiskFDA
W & C Dba The Apothecary
Prostaglandin 200 mcg/ 0.1 mL -- 25 mL GLASS VIAL, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sartell, MN 56377
Drugs·10 affected·Jun 20, 2016
High RiskFDA
Medtronic Navigation
PoleStar system (N20 / N30) Warning Lamps Control Box, Warning Lamps Control Box Cables, Thermoflex Chiller Product The PoleStar Surgi...
Surgical Devices·52 affected·Jun 20, 2016
High RiskFDA
Karl Storz Endoscopy
Image1 SPIES X-LINK Camera Control Unit (CCU), Product Model No. TC301, when used with Image1 SPIES D1 camera head, Product Model No. TH1...
Medical Devices·619 affected·Jun 20, 2016
High RiskFDA
Anthogyr
Axiom 2.8 implants Sterile The Axiom REG implants are used as artificial root structures for replacement of missing teeth. They can b...
Medical Implants·10 affected·Jun 20, 2016
High RiskFDA
Gardner Pie Company
Product is a 32-ounce Key Lime pie sold at the firm's retail outlet only. Pie is packed in a cardboard carton with an aluminum pie pan an...
Food·163 affected·Jun 17, 2016
High RiskFDA
Gardner Pie Company
Product is a 29-ounce/9" cheesecake packed in a cardboard carton in an aluminum pie pan with a plastic dome lid. Pies for further distr...
Dairy·600 affected·Jun 17, 2016
High RiskFDA
Tippin's Gourmet Pies, Llc
Tippins 8" Key Lime Base packaged in ?. UPC code is 680816001851. Packaged in 12 pie bases per case. Shipped frozen. Net wt. 21oz each.
Frozen Food·30 affected·Jun 17, 2016
High RiskFDA
Tippin's Gourmet Pies, Llc
Tippins 9" Cream Cheese Base packaged in ?. UPC code is 680816002711. Packaged in 18 pie bases per case. Shipped frozen.
Dairy·60 affected·Jun 17, 2016
High RiskFDA
Tippin's Gourmet Pies, Llc
Tippins Mini Key Lime Base packaged in ?. UPC code is 680816000106. Packaged in 30 pie bases per case. Shipped frozen. Net wt. 11oz each.
Frozen Food·32 affected·Jun 17, 2016
High RiskFDA
Fresh Express Incorpated
Fresh Express Kit Caesar salad, Net Wt. 7.6 oz. (215g), Fresh Express Incorporated, 550 S. Caldwell St. Charlotte, NC 28202, packed in cl...
Produce·2,449 affected·Jun 17, 2016
High RiskFDA
Sustainable Community Development Llc Dba Scd Probiotics
Xtra Immunity Brown Rice Antioxidant Probiotic Extract, a liquid packaged in a 500mL bottle. UPC 184368000114. The responsible firm name...
Food·3,940 affected·Jun 17, 2016
High RiskFDA
Tippin's Gourmet Pies, Llc
Tippins 9" Keylime Base packaged in ?. UPC code is 680816000205. Packaged in 18 pie bases per case. Shipped frozen. Net wt. 31oz each.
Frozen Food·60 affected·Jun 17, 2016
High RiskFDA
Tippin's Gourmet Pies, Llc
Tippins 8" Key Lime Pie packaged in aluminum pie plates with plastic covers. The responsible firm listed on the label is TGP, LLC Kansas...
Frozen Food·1,137 affected·Jun 17, 2016
High RiskFDA
Teva North America
ARGATROBAN Injection in 0.9% Sodium Chloride 250 mg/250 mL (1 mg/mL) , Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC...
Injectable Drugs·1,299 affected·Jun 17, 2016
High RiskFDA
Teva North America
Linezolid Injection 600 mg/300 mL Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC# 0703-...
Injectable Drugs·92,480 affected·Jun 17, 2016
High RiskFDA
Teva North America
Eptifibatide Injection 75 mg/100 mL (0.75 mg/mL) single use vial, For Intravenous Use Only, Rx Only, Manufactured in Hungary for TEVA PHA...
Injectable Drugs·14,661 affected·Jun 17, 2016
High RiskFDA
Teva North America
Ondansetron Injection USP 40 mg/20 mL (2 mg/mL), Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 194...
Injectable Drugs·13,223 affected·Jun 17, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA¿ Chemistry (Syva Onboard) Theophylline_2 (THEO_2) Reagent is for in vitro diagnostic use in the quantitative analysis of theophylli...
Diagnostic Devices·658 affected·Jun 17, 2016
High RiskFDA
Elekta, Inc.
MOSAIQ Oncology Information System
Medical Devices·69 affected·Jun 17, 2016
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
6.0mm Round Fluted Bur, Super Long
Medical Devices·25 affected·Jun 16, 2016
High RiskFDA
Halyard Health, Inc
Coolife Sinergy Radiofrequency Kit, SIK-17-75-4 (109971504); Kit used in conjunction with a Radiofrequency Generator to create radiofrequ...
Medical Devices·51 affected·Jun 16, 2016
High RiskFDA
Ab Sciex
AB Sciex API 3200MD" LC/MS/MS System. In-Vitro Diagnostic Instrument Part Number (REF): 5024501 3200MD series and 4500MD series are mas...
Diagnostic Devices·124 affected·Jun 16, 2016
High RiskFDA
Ab Sciex
AB SCIEX QTRAP¿ 4500MD LC/MS/MS System Mass Spectrometer for In-Vitro Diagnostic Use. Instrument Part Number (REF): 5031231 3200MD se...
Diagnostic Devices·28 affected·Jun 16, 2016
High RiskFDA
Ab Sciex
AB SCIEX 3200MD QTRAP¿ LC/MS/MS System Mass Spectrometer for In-Vitro Diagnostic Use. Instrument Part Number (REF): 5024500 3200MD se...
Diagnostic Devices·2 affected·Jun 16, 2016
High RiskFDA
Gasco Industrial
Label reads in part as: "NuChef Soy Sauce***Contenido Neto (Net Content): 1 Gal¿n (1 Gallon) (128 fl. oz.)***P.O. Box 10718, San Juan PR ...
Food·154 affected·Jun 15, 2016
High RiskFDA
Armour Eckrich Meats Llc
Armour Snackmaker Keebler Animals Crackers, Chocolate Icing with Natural and Artificial Flavors, Plain Icing which are packaged in 2.7oz ...
Meat & Poultry·5,403 affected·Jun 15, 2016