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High RiskFDA
Biomet 3i, Llc
Standard Abutment Pick -Up Coping Dental implants
Medical Implants·1,648,273 affected·Nov 25, 2015
High RiskFDA
Biomet 3i, Llc
Implant EP Twist Lock TM Coping Dental implants
Medical Implants·1 affected·Nov 25, 2015
High RiskFDA
Biomet 3i, Llc
Certain Pick-Up Coping 4.1mm(D) x 5mm(P) Item: IIIC12 Dental implants
Medical Implants·1,648,273 affected·Nov 25, 2015
High RiskFDA
Biomet 3i, Llc
Certain Temporary Hexed Cylinder Dental implants
Medical Implants·1,648,273 affected·Nov 25, 2015
High RiskFDA
Abeon Medical Corporation
TLC¿ Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE EO Rx ONLY. Indicated for use in the retractio...
Medical Devices·2,570 affected·Nov 25, 2015
High RiskFDA
Biomet 3i, Llc
Conical EP Pick-Up Coping (Hexed) Dental implants
Medical Implants·1,648,273 affected·Nov 25, 2015
High RiskFDA
Boston Scientific Corporation
Boston Scientific ACUITY Pro Coronary Sinus Guide Catheter, 9 Fr. Model 8104, 8105, 8106, 8107, 8108, 8109, 8110, 8111, 8112, 8113, 8114...
Medical Implants·900 affected·Nov 25, 2015
High RiskFDA
Kci Usa, Inc.
ActiV.A.C. 300ml Canister (with Gel) for ActiV.A.C. Therapy System for the application of V.A.C. Therapy in the acute extended and home c...
Medical Devices·12,728 affected·Nov 25, 2015
High RiskFDA
Thai Culinary Arts Studio Llc
Watcharee's Thai Green Curry Sauce (UPC 094368999991), product is in a glass jar, NET WT 11.5 OZ (326 g)
Food·4,327 affected·Nov 24, 2015
High RiskFDA
Thai Culinary Arts Studio Llc
WATCHAREE'S thai peanut sauce (UPC 094368999977), product is in a glass jar, NET WT 11.75 OZ (333 g)
Food·4,327 affected·Nov 24, 2015
High RiskFDA
Instratek, Incorporated
Hook Blade, Angled. Part number 7058A. Sterile disposable blade for use with Endoscopic Tarsal Tunnel Decompression (ETTD) System.
Medical Devices·39 affected·Nov 24, 2015
High RiskFDA
Elekta, Inc.
MOSAIQ Oncology Information System. Used to manage workflows for treatment planning and delivery.
Medical Devices·211 affected·Nov 24, 2015
High RiskFDA
Zimmer, Inc.
Persona EM Distal Rod, orthopedic manual surgical instrument for use with Persona Knee Prosthesis, item 42-5399-002-00, part of the Perso...
Medical Implants·156 affected·Nov 24, 2015
High RiskFDA
Nicomex Inc.
Nicomex Velitas Candies Candles Net. Wt. 2 oz (56.7 gms) Distributed by Nicomex Inc. 88 First Street, Passaic, NJ 07055
Food·316 affected·Nov 23, 2015
High RiskFDA
Biomerieux Inc
Granada Biphasic Broth The product is a selective medium for the screening and identification of Streptococcus agalactiae in pregnant ...
Medical Devices·24 affected·Nov 23, 2015
High RiskFDA
Intuitive Surgical, Inc.
30 deg, 8mm Endoscope, IS4000: Model numbers: 470027-34, 470027-40, 470027-41. General and Plastic Surgery: The da Vinci Xi endoscop...
Medical Devices·2,624 affected·Nov 23, 2015
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Cournand Modified 2-PC 19G, 5.4cm or (Guidewire Introducer Needle) 20 units per case The Stryker Guidewire Introducer Needles are desig...
Surgical Devices·120 affected·Nov 23, 2015
High RiskFDA
Zyto Technologies, Inc.
The ZYTO Select and ZYTO Elite software programs are used to rank pairs of galvanic skin response measurements from most coherent (the se...
Medical Devices·1,252 affected·Nov 23, 2015
High RiskFDA
Terumo Medical Corp
Terumo Surflo Winged Infusion Set with Filter and Needle Protection (Surshield), Product Code: SV-S25FL35.
Medical Devices·80,500 affected·Nov 23, 2015
High RiskFDA
Intuitive Surgical, Inc.
0 deg, 8mm Endoscope, IS4000: Model numbers: 470026-34, 470026-40, 470026-41. General and Plastic Surgery: The da Vinci Xi endoscope...
Medical Devices·2,624 affected·Nov 23, 2015
High RiskFDA
Heb Retail Support Center
Mi Tienda Tostaditas Botoneras Rojas packaged in bag
Food·14 affected·Nov 20, 2015
High RiskFDA
Heb Retail Support Center
Mi Tienda Masa Preparada By the Pound packaged in bag
Food·15 affected·Nov 20, 2015
High RiskFDA
Made In Nature, Llc
Pacific Superfoods Snack Lava Rock Sriracha Kale Chips, 2.2oz or 62g, In a clamshell container with a paper sleeve, 8 packages per case
Snacks & Candy·8,500 affected·Nov 20, 2015
High RiskFDA
Made In Nature, Llc
Made In Nature Sriracha Chili Kale Chips, 2.2oz or 62g, In a clamshell container with a paper sleeve, 8 packages per case
Snacks & Candy·50,176 affected·Nov 20, 2015
High RiskFDA
Heb Retail Support Center
Mi Tienda Tostada Siveria Large Tostada packaged in bag
Food·30 affected·Nov 20, 2015
High RiskFDA
Depuy Spine, Inc.
Aegis Torque Handle CATALOG NO. : 2871-10-800. A spinal surgical instrument used on the AEGIS Anterior Lumbar Plate System.
Surgical Devices·16 affected·Nov 20, 2015
High RiskFDA
Boston Scientific Corp
IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-8 Material Number: M004PM4500N40; Catalog number: PM4500N4; Cardiac: The Int...
Cardiac Devices·1,556 affected·Nov 20, 2015
High RiskFDA
Depuy Mitek, Inc., A Johnson & Johnson Co.
FMS neXtra¿ 3.5mm Aggressive Cutter Shaver Blades; Product Code: 283315 Intended to provide controlled cutting, shaving, and abrading ...
Medical Devices·45 affected·Nov 20, 2015
High RiskFDA
Steris Corporation
AMSCO¿ Warming Cabinet. Manufactured by: STERIS Corporation To raise the temperature of blankets, linens and sterile surgical IV/irri...
Surgical Devices·2,319 affected·Nov 20, 2015
High RiskFDA
Depuy Mitek, Inc., A Johnson & Johnson Co.
FMS 3.5mm Ultra-Aggressive Cutter Shaver Blades; Product Code: 287325 Intended to provide controlled cutting, shaving, and abrading of...
Medical Devices·115 affected·Nov 20, 2015
High RiskFDA
Bigwall Enterprises
WARM STEAM Personal Steam Inhaler-Adjustable control to regulate flow of steam Soft touch facial & nasal masks" Product labeling reads i...
Medical Devices·87,503 affected·Nov 20, 2015
High RiskFDA
Boston Scientific Corp
IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-10 ; Material Number: M004PM4790N40; Catalog number: PM4790N4; Cardiac: The ...
Cardiac Devices·1,556 affected·Nov 20, 2015
High RiskFDA
Jensens Old Fashioned Smokehouse Inc
Teriyaki hot smoked Atlantic salmon, Teriyaki hot smoked King salmon, Teriyaki hot smoked Sockeye salmon, Teriyaki hot smoked salm...
Seafood·1,533 affected·Nov 19, 2015
High RiskFDA
Cook Inc.
VentriClear¿ II Ventricular Drainage Catheter Set. Allows external access and drainage of cerebrospinal fluid (CSF) from the ventricles ...
Surgical Devices·35 affected·Nov 19, 2015
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Factor VIII Chromogenic Assay, REF/Catalog No. B4238-40, Siemens Material Number (SMN) 10445729, IVD. --- CLASSIFICATION NAME: Test, Qua...
Diagnostic Devices·52 affected·Nov 19, 2015
High RiskFDA
Mevion Medical Systems, Inc.
MEVION S250 Radiation therapy system
Medical Devices·4 affected·Nov 18, 2015
High RiskFDA
Radiometer America Inc
TCM CombiM Modules 903-111
Medical Devices·1,488 affected·Nov 18, 2015
High RiskFDA
Rainbow Specialty & Health Products
Dressol-X, Radiopaque D-502, NDC 11004-502-40, Dental Use Only, Active Ingredients: A.S.A. (Acetylsalicylic Acid) + Eugenol
Medical Devices·2,775 affected·Nov 18, 2015
High RiskFDA
In2bones, Sas
IBS - Osteosynthesis screws for bone fixation Model S25 ST014.
Medical Devices·20 affected·Nov 18, 2015
High RiskFDA
Hardy Diagnostics
FB Broth, 10ml (Fastidious Bacteria Broth) Cat. no: K31 Lot: 15231 A fastidious bacteria broth for the enriched cultivation of Nei...
Medical Devices·500 affected·Nov 18, 2015
High RiskFDA
Casey's Bakery, Inc
Casey's Bakery, Almond Patties, Traditional Dutch Puff Pastry Filled with Pure Almond Paste, 6 Patties, NET WT 13.5 OZ
Bakery & Grains·904 affected·Nov 17, 2015
High RiskFDA
Biomet, Inc.
Biomet Integral Centralizer Hip System, Lateralized Femoral Stem (Co-Cr-Mo), 9mm, 11mm, 13mm, 15mm, and 17mm
Medical Devices·21 affected·Nov 17, 2015
High RiskFDA
Merge Healthcare, Inc.
Merge RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
Medical Devices·8 affected·Nov 17, 2015
High RiskFDA
Olympus Corporation Of The Americas
Olympus ENDOEYE HD II Video Telescopes. Models WA50040A ENDOEYE HD II, 10 mm, 0 degree, WA50042A ENDOEYE HD II 10 mm, 30 degree, W710060...
Medical Devices·182 affected·Nov 17, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
Syngo Imaging XS is a Picture Archiving and Communication System (PACS)
Medical Devices·42 affected·Nov 17, 2015
High RiskFDA
Owens & Minor Distribution, Inc.
MediChoice Cohesive Bandages, One (1) roll of cohesive bandage per bag, thirty-six (36) bags per case [all model numbers have equivalent ...
Medical Devices·96,266 affected·Nov 17, 2015
High RiskFDA
Thrive Foods Llc
Organic blenditup Protein + Plant Based Smoothie Mix, No Dairy, Vitamin Fortified, 100% Vegan, Mild Natural Flavor with a Hint of Sweetne...
Dairy·5,305 affected·Nov 16, 2015
High RiskFDA
Biomet 3i, Llc
Radiographic Transparency for Certain and External Connection Tapered Implants. Images that assist with measurements for dental implants.
Medical Implants·686 affected·Nov 16, 2015