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High RiskFDA
Volcano Corporation
Philips Volcano CORE M2 Vascular System, Part # 400-0100.17, Rx Only. Used for the qualitative and quantitative evaluation of vascular...
Medical Devices·8 affected·Mar 22, 2018
High RiskFDA
Ge Medical Systems Ultrasound & Primary Care Diagnostics, Ll
GE Vivid 7 ultrasound system Product Usage: Vivid E7 is a general-purpose ultrasound system, specialized for use in cardiac imaging. I...
Cardiac Devices·12,426 affected·Mar 22, 2018
High RiskFDA
Bard Medical Division
Bard Midstream Urine Collector with Rigid Funnel and Iodophor Prep Pads. Product Packaging: Three (3) PVP-I prep pads are packed into ea...
Medical Devices·131,950 affected·Mar 21, 2018
High RiskFDA
Madison Polymeric Engineering
First Step Endoscopic Cleaning Pad, 100ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-3
Medical Devices·115 affected·Mar 21, 2018
High RiskFDA
Madison Polymeric Engineering
Travel Kit, First Step EP-4 Kit (200 mL) and 1 Soiled Scope Bag (White), Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number TK-20...
Medical Devices·23 affected·Mar 21, 2018
High RiskFDA
Madison Polymeric Engineering
First Step Endoscopic Cleaning Pad, 200ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-4
Medical Devices·1,422 affected·Mar 21, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista¿ MULTI 2 SDIL, KD694, SMN# 10483586
Medical Devices·1,195 affected·Mar 21, 2018
High RiskFDA
Madison Polymeric Engineering
First Step Endoscopic Cleaning Pad, 500ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-6
Medical Devices·359 affected·Mar 21, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista¿ MULTI 1 SDIL, KD693, SMN# 10469971
Medical Devices·197 affected·Mar 21, 2018
High RiskFDA
Becton Dickinson & Company
BD Vacutainer¿ Ultra TouchTM Push Button Blood Collection Set 0.6 x 19 mm x 305 mm 23G x ¿ x 12. Catalog no 367364
Medical Devices·0 affected·Mar 20, 2018
High RiskFDA
Epic Extremity, Llc
Epic Extremity Plate System,10x10 Plate Caddy, Part 2111-1010 with 2.7 and 3.5mm Non-Locking Screw (2001-27XX-N & 2001-35XX-N)
Medical Devices·9 affected·Mar 20, 2018
High RiskFDA
Epic Extremity, Llc
Epic Extremity Plate System, Midfoot/Flatfoot Insert, Part 2111-0005 with Extended Butterfly Plate (2000-5002)
Medical Devices·6 affected·Mar 20, 2018
High RiskFDA
Becton Dickinson & Company
BD Vacutainer¿ Push Button Blood Collection Set 0.8 x 19 mm x 305 mm 21G x ¿ x 12 Catalog 367344
Medical Devices·0 affected·Mar 20, 2018
High RiskFDA
Teva Pharmaceuticals Usa
Estradiol Vaginal Inserts, USP 10 mcg, packaged in a) 8 inserts/carton (NDC 0093-3223-08) and b) 18 inserts/carton (NDC 0093-3223-97), Rx...
Drugs·640,486 affected·Mar 19, 2018
High RiskFDA
Teleflex Medical Europe Ltd
Teleflex MEDICAL LMA(TM) MADgic(TM) LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE, MAD700, QTY: 1 Intended for the application of topical a...
Medical Devices·25 affected·Mar 19, 2018
High RiskFDA
Hycor Biomedical Inc
HYTEC 288 System, Model 74007P, automated immunoanalyzer (EIA) instrument. For in vitro diagnostic use only. HYTEC AUTOSTAT II RF as...
Diagnostic Devices·288 affected·Mar 19, 2018
High RiskFDA
J.m.rosen Cheesecake
J.M. Rosen's Cheesecake - New York Traditional; 6 - Unit- 4/46 oz in a case box; Product #56378 UPC 6 93892 99462 7; INGREDIENTS: C...
Dairy·119 affected·Mar 16, 2018
High RiskFDA
Izzy's Ice Cream, Llc
Izzy's Ice Cream, Maple Nut, One Pint (473 ml), UPC 51115-00106. Izzy's Ice Cream, 1100 2nd Street S., Minneapolis, MN 55415.
Dairy·264 affected·Mar 16, 2018
High RiskFDA
Oregon Food Bank
Roasted Pumpkin Seeds, packaged in 1 lbs. poly film bags with a twist type closure or in a re-sealable pouch, labeled as "distributed by ...
Food·61,106 affected·Mar 16, 2018
High RiskFDA
J.m.rosen Cheesecake
J.M. Rosen's Cheesecake - Fantasy; 9 - Unit- 64 Slices in a case box; Product #55993 UPC 6 89076 70759 6; INGREDIENTS: Cream Chees...
Dairy·30 affected·Mar 16, 2018
High RiskFDA
Nobel Biocare Usa Llc
Nobel Biocare 17¿ Multi-Unit Abutment, Conical Connection NP, 2.5mm, REF 36614. Product Usage: Intended to be used in the upper and low...
Medical Implants·74 affected·Mar 16, 2018
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns TCM II, Catalog Numbers: 4415; 4416;164925; 164930;164935;164940 UDI 00886799000014 The Sarns TCM is indicated for controlling a...
Medical Devices·2,393 affected·Mar 16, 2018
High RiskFDA
Philips Electronics North America Corporation
T5-NT, Model 78104 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic imag...
Diagnostic Devices·8,205 affected·Mar 16, 2018
High RiskFDA
Philips Electronics North America Corporation
Multiva systems, 1) Multiva 1.5T 8 R5 Model 781072, 2) Multiva 1.5T 16 R5 Model 781073, 3) Multiva 1.5T 8ch R5 based Model 781074, 4) Mul...
Diagnostic Devices·8,205 affected·Mar 16, 2018
High RiskFDA
Philips Electronics North America Corporation
Conversion SmarthPath to dStream for 1.5T, Model 781260 Product Usage: Indicated for use as a diagnostic device. It can produce cross...
Diagnostic Devices·8,205 affected·Mar 16, 2018
High RiskFDA
Philips Electronics North America Corporation
Achieva 1.5T: 1) Nova (Dual), Model 781173, 2) Achieva 1.5T Initial Systems Model 781178, 3) Achieva 1.5T Nova Model 781196, 4) Achieva 1...
Diagnostic Devices·8,205 affected·Mar 16, 2018
High RiskFDA
Philips Electronics North America Corporation
T10-NT, Model 78107 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic ima...
Diagnostic Devices·8,205 affected·Mar 16, 2018
High RiskFDA
Philips Electronics North America Corporation
Intera 0.5T Standard, Model 781101 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, sp...
Diagnostic Devices·8,205 affected·Mar 16, 2018
High RiskFDA
Philips Electronics North America Corporation
Panorama 1.0T, Model 781250 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectrosc...
Diagnostic Devices·8,205 affected·Mar 16, 2018
High RiskFDA
Ge Medical Systems Ultrasound & Primary Care Diagnostics, Ll
GE Healthcare Lunar: a) DPX NT, Model Numbers: LU8230, LU40338, LU42357, LU42369 b) DPX MD+, Model Numbers: LU8230, LU40338, LU40352 ...
Medical Devices·43 affected·Mar 16, 2018
High RiskFDA
Teleflex Medical Europe Ltd
Simplastic Suprapubic Puncture Instruments: Product Code Equivalent Code (a) 650704100 551310 (b) 650704120 551312 ...
Medical Devices·4,220 affected·Mar 15, 2018
High RiskFDA
Biocare Medical, Llc
URO-3 Triple Stain (CD44 + p53) with CK20, Catalog #: PM370TSAA, Package Type: Bag, which contains components: a) CD44 + p53, Catalog #: ...
Diagnostic Devices·11 affected·Mar 15, 2018
High RiskFDA
Teleflex Medical Europe Ltd
Rectal Catheters; Product Code Equivalent Code 580114 580114 Product Usage: Rectal Balloon Catheter is inserted into t...
Surgical Devices·6,340 affected·Mar 15, 2018
High RiskFDA
Teleflex Medical Europe Ltd
Latex Rebreathing Bags: Product Code Equivalent Code (a) 151174050 151174 (b) 153000005 153000005 (c) 153000010 153000010 (d) 153000...
Respiratory Devices·107,962 affected·Mar 15, 2018
High RiskFDA
Zimmer Gmbh
Normed Charcot Osteotome Chisel (Various sizes)
Medical Devices·0 affected·Mar 15, 2018
High RiskFDA
Teleflex Medical Europe Ltd
Baker Jejunostomy Tubes: Product Code Equivalent Code (a) 655300160 655316 (b) 655500200 655520
Medical Devices·200 affected·Mar 15, 2018
High RiskFDA
Griffith Foods
Product Name Lot Number or ID Premix Roasted Chicken 1258969 660025
Meat & Poultry·1 affected·Mar 14, 2018
High RiskFDA
Newly Weds Foods Inc
Lbs, flv roast dark type, 30 # Boxes
Food·1 affected·Mar 14, 2018
High RiskFDA
Griffith Foods
Product Name Lot Number or ID Whiskey & Cola Type Flavored Seasoning 660373
Food·60 affected·Mar 14, 2018
High RiskFDA
Griffith Foods
Product Name Lot Number or ID Fire Roasted Steak Type Seasoning 655697
Food·36 affected·Mar 14, 2018
High RiskFDA
Griffith Foods
Product Name Lot Number or ID Au Jus Seasoning Reduced Sodium 659868, 660660, 660661, 660662, 660663 Au Jus Seasoning Reduced Sodi...
Food·1,175 affected·Mar 14, 2018
High RiskFDA
Newly Weds Foods Inc
Bourbon Brown Sugar Rub SE746665, 50# Bags
Food·20 affected·Mar 14, 2018
High RiskFDA
Precise Food Ingredients, Inc.
Roast Beef Gravy Seasoning Manufacturer's code: PF07040000 packaged in a multi-walled paper bag with poly liner, 28 pounds
Meat & Poultry·896 affected·Mar 14, 2018
High RiskFDA
Griffith Foods
Product Name Lot Number or ID Salt & Vinegar Seasoning - 50 LB CS 662977
Food·43 affected·Mar 14, 2018
High RiskFDA
Griffith Foods
Product Name Lot Number or ID Roasted Wing Marinade Seasoning 661107
Food·76 affected·Mar 14, 2018
High RiskFDA
Griffith Foods
Product Name Lot Number or ID Pan Roast Brown Gravy Mix 659281, 659282, 659283, 659284, 659285, 659286 Pan Roast Brown Gravy Mix 661...
Food·9,037 affected·Mar 14, 2018
High RiskFDA
Newly Weds Foods Inc
Roast Grill Seasoning SE746664, 50# Bags
Food·10 affected·Mar 14, 2018
High RiskFDA
Newly Weds Foods Inc
Au Jus Seasoning BM652767; bulk 50 lb boxes
Food·20 affected·Mar 14, 2018