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High RiskFDA
Newly Weds Foods Inc
Roast Chicken Marinade SE746125 and SE746126, 50# Bags
Meat & Poultry·160 affected·Mar 14, 2018
High RiskFDA
Griffith Foods
Product Name Lot Number or ID Toasted Italian Herbs 661126
Food·66 affected·Mar 14, 2018
High RiskFDA
Philips Electronics North America Corporation
Allura Xper R8.x.25.5 and UNIZ systems (only with a FlexVision large screen monitor), Interventional fluoroscopic x-ray system Product...
Medical Implants·682 affected·Mar 14, 2018
High RiskFDA
Invivo Corporation
PHILIPS Xper Flex Cardio Physiomonitoring System, Model Numbers: 453564241901, 453564483321, 453564621791, and 989803199561 (internation...
Cardiac Devices·4,375 affected·Mar 14, 2018
High RiskFDA
Accelerate Diagnostics Inc
Accelerate PhenoTest BC kit, Ref #10101018. The firm name on the label is Accelerate Diagnostics, Tucson, AZ. A multiplexed in-vitro ...
Diagnostic Devices·95 affected·Mar 14, 2018
High RiskFDA
Philips Electronics North America Corp.
Philips HeartStart FRx AED.
Cardiac Devices·1 affected·Mar 14, 2018
High RiskFDA
Implant Direct Sybron Manufacturing, Llc
ImplantDirect simply InterActive Implant, 5.0mmD X 10mmL, SBM: 3.4mmD Platform, Part #655010U, Rx, Sterile. Incorrect label on the cap s...
Medical Implants·298 affected·Mar 14, 2018
High RiskFDA
Premier Food Management, Llc
Chicken bacon, egg white and cheese on flat bread sandwich
Dairy·79 affected·Mar 13, 2018
High RiskFDA
Mondelez Global Llc
Sour Patch Kids, 1.9 lb bag
Food·1,814 affected·Mar 13, 2018
High RiskFDA
Medtronic Vascular
Medtronic DxTerity Diagnostic Catheter, JL 4.0, REF DXT5JL40, marked with 6F color code on box.
Surgical Devices·855 affected·Mar 13, 2018
High RiskFDA
Keystone Dental Inc
Genesis Surgical Cassette Tapered Implants are intended for placement following natural tooth loss or for immediate placement into a...
Medical Implants·19 affected·Mar 13, 2018
High RiskFDA
Livanova Usa
Inspire 8 Integrated Phisio OXY w/ HVR Reservoir, Sterile EO, Catalog # 050714 The intended uses for the two elements that constitute...
Respiratory Devices·70 affected·Mar 13, 2018
High RiskFDA
Livanova Usa
Inspire 6 Integrated Phisio OXY w/ HVR Reservoir, Sterile EO, Catalog # 050713 The intended uses for the two elements that constitute ...
Respiratory Devices·42 affected·Mar 13, 2018
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Medtronic Prestige LP(TM) Cervical Disc System with Streamlined Instruments, DRILL GUIDES: a) REF 6975205, 5mm b) REF 6975206, 6mm c) ...
Medical Implants·231 affected·Mar 13, 2018
High RiskFDA
Food And Beverage Inc.
Name: Trader Joe s Chocolate Chip Cookies SKU 68075 Net Weight: 12 oz. (340g) Number of units per package: 16 cookies Package type: Kr...
Bakery & Grains·2,851 affected·Mar 12, 2018
High RiskFDA
Micro-tech (nanjing) Co., Ltd.
Trident Endoscopic Ultrasonic Biopsy Needle (FNB)
Medical Devices·40 affected·Mar 12, 2018
High RiskFDA
Hamilton Medical Ag
Hamilton-C2 Ventilator Unit Intended to provide ventilator support to adults and pediatrics and optionally infants and neonates in the...
Respiratory Devices·739 affected·Mar 12, 2018
High RiskFDA
Stryker Gmbh
Hinge Coupling Hoffmann LRF Catalog # 4933-0-800 Intended for fixation of fractures, joint contractures, fusions, limb lengthening, de...
Medical Devices·18 affected·Mar 12, 2018
High RiskFDA
Micro-tech (nanjing) Co., Ltd.
Trident Endoscopic Ultrasonic Aspiration Needle (FNA)
Medical Devices·40 affected·Mar 12, 2018
High RiskFDA
Mckesson Israel Ltd.
McKesson Cardiology Hemo, Release SW version 13.0. Used for physiological monitoring, image and data processing. McKesson Cardiology...
Medical Devices·31 affected·Mar 12, 2018
High RiskFDA
Schwartz Brothers Restaurants Dba Schwartz Brothers Bakery
Gourmet Cream Cheese Cinnamon Rolls, packaged in a 16 oz. plastic clam shell container and sold under the Schwartz Brothers Bakery brand....
Dairy·106 affected·Mar 11, 2018
High RiskFDA
Richard Wolf Gmbh
RICHARD WOLF TUBE SET FOR TEM, REF 4170.801. Used for the transanal endoscopic microsurgery.
Medical Devices·1,710 affected·Mar 11, 2018
High RiskFDA
Maplehurst Bakeries, Llc.
ITALIAN BREAD, SKU: 10424, Frozen Dough
Bakery & Grains·960 affected·Mar 10, 2018
High RiskFDA
Maplehurst Bakeries, Llc.
RAISIN BREAD, SKU: 10460, Frozen Dough
Bakery & Grains·60 affected·Mar 10, 2018
High RiskFDA
Maplehurst Bakeries, Llc.
100% WHOLE WHEAT BREAD DOUGH, SKU: 11895, Frozen
Bakery & Grains·120 affected·Mar 10, 2018
High RiskFDA
Oregon Food Bank
Chia Seeds packaged in poly film bags as both a twist type closure and a re-sealable pouch, net wt. 1 lb.
Food·22,201 affected·Mar 9, 2018
High RiskFDA
Nestle Dreyers Ice Cream Company
Dreyer's Slow Churned Vanilla Bean Ice Cream; 1.5 qt, (48-fl oz.); Lid is for Dreyer's Slow Churned Butter Pecan Ice Cream UPC 41548...
Dairy·30 affected·Mar 9, 2018
High RiskFDA
The Binding Site Group, Ltd.
Binding Site Optilite Beta-2-Microglobulin Urine Kit, Ref LK043.L.OPT.A, IVD. The firm name on the label is The Binding Site Group Ltd.,...
Medical Devices·20 affected·Mar 9, 2018
High RiskFDA
Stryker Medical Division Of Stryker Corporation
6381 M-1 Cot Fastener, catalog no. 6381000000
Medical Devices·3 affected·Mar 9, 2018
High RiskFDA
Hamilton Medical Ag
Hamilton-C3 Ventilator Unit Product Usage: The HAMILTON-C3 ventilator is intended to provide positive pressure ventilator support to ...
Respiratory Devices·2 affected·Mar 9, 2018
High RiskFDA
Hamilton Medical Ag
Hamilton-C1 Ventilator Unit Product Usage: The HAMILTON-C1 ventilator is intended to provide positive pressure ventilation support to...
Respiratory Devices·16 affected·Mar 9, 2018
High RiskFDA
Adm Agri Industries
Provim ESP Vita Wheat Gluten, Product code 6303, 50 lb bag
Food·6,080 affected·Mar 8, 2018
High RiskFDA
Bracco Diagnostics Inc.
E-Z-Paste Barium Sulfate Esophageal Cream (60% w/w), 454 g tube, Rx only, Manufactured by E-Z-EM Canada Inc. for E-Z-EM Inc. a subsidiar...
Topical Drugs·2,136 affected·Mar 8, 2018
High RiskFDA
Southern Implants, (pty.) Ltd.
SOUTHERN IMPLANTS REF IBR12d-13, Implant, Ext. Hex, tapered 12o Co-Axis(TM) intended for surgical placement in the upper or lower jaw to ...
Medical Implants·49 affected·Mar 8, 2018
High RiskFDA
Oregon Wild Berries, Inc.
Mushroom Condensed Soup, brand Chef Edwin's, packaged in glass pint Kerr jars, Net wt. 14 oz. UPC 7 00424 66845 8. The product label ...
Produce·123 affected·Mar 7, 2018
High RiskFDA
Apollo Care
Vancomycin 1.25g added to 250 mL of 0.9% Sodium Chloride IV bag, Rx only, APOLLOcare, 3801 Mojave Ct., Suite 101, Columbia, MO 65202, NDC...
Injectable Drugs·96 affected·Mar 7, 2018
High RiskFDA
American Pharmaceutical Ingredients Llc
Oxytocin USP, powder, 1g-bottle, API American Pharmaceutical Ingredients, NDC 58597-7042-3
Drugs·21 affected·Mar 7, 2018
High RiskFDA
Apollo Care
Vancomycin 1g added to 250mL of 0.9% Sodium Chloride IV bag, Rx only, APOLLOcare, 3801 Mojave Ct., Suite 101, Columbia, MO 65202, NDC 711...
Injectable Drugs·144 affected·Mar 7, 2018
High RiskFDA
American Pharmaceutical Ingredients Llc
Sermorelin Acetate, powder, a) 1 GM-bottle (NDC58597-8092-1) b) 5 GM-bottle (NDC 58597-8092-2) c) 10 GM-bottle (NDC 58597-8092-4) API Ame...
Drugs·1,460 affected·Mar 7, 2018
High RiskFDA
Ethicon, Inc.
Evicel Accessory Device - 45 cm Flexible Tip (SET OF 3), Product Code EVT45. Accessory Tips for use only with EVICEL Fibrin Sealant (Hum...
Medical Devices·738 affected·Mar 7, 2018
High RiskFDA
Intuitive Surgical, Inc.
da Vinci X Surgical System, Model IS4200. Product Usage: The Intuitive Surgical Endoscopic Instrument Control System (da Vinci X Surg...
Cardiac Devices·108 affected·Mar 7, 2018
High RiskFDA
Sps Sterilization, Inc
Edwards Lifesciences Avid Dual Stage Venous Drainage Cannula, 29/37F (9.6/12.3MM) X 37CM (14.5"), resterilized.
Medical Devices·5 affected·Mar 7, 2018
High RiskFDA
Sps Sterilization, Inc
Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 34F (11.3MM) X 40CM (16"), resterilized.
Medical Devices·5 affected·Mar 7, 2018
High RiskFDA
Smith & Nephew, Inc.
D-RAD Self-Tapping Locking Screw intended for the fixation of fractures involving the distal radius. smith&nephew D-RAD 2.4MM X 10MM S-T ...
Medical Devices·59 affected·Mar 7, 2018
High RiskFDA
Sps Sterilization, Inc
Boston Scientific Wallstent Endoprosthesis Tracheobronchial Transhepatic Biliary Self-Expanding Stent, 12MM X 90MM | 75CM L, resterilized.
Medical Implants·2 affected·Mar 7, 2018
High RiskFDA
Sps Sterilization, Inc
Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 38FRX40CM, resterilized.
Medical Devices·10 affected·Mar 7, 2018
High RiskFDA
Sps Sterilization, Inc
Boston Scientific Wallstent Enteral Endoprosthesis Colonic/Duodenal Stent, 22MM X 90MM, resterilized.
Medical Implants·2 affected·Mar 7, 2018
High RiskFDA
Autochair
Product: Milford Smartbase Model # 9934105 Pride SmartBase Pride product codes: LSMPLCG A & LSMPLCG B
Medical Devices·0 affected·Mar 7, 2018