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High RiskFDA
Medtronic Neuromodulation
Vanta with AdaptiveStim Implantable Neurostimulator, Model 977006; spinal chord stimulation
Medical Implants·3,791 affected·Jun 6, 2023
High RiskFDA
Murata Vios, Inc.
Vios Monitoring System Bedside Monitor, Model BSM2050, Software Version Numbers 1.54.20 and 1.56.00
Medical Devices·44 affected·Jun 6, 2023
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981027725, spinal implant
Medical Implants·8 affected·Jun 6, 2023
CriticalFDA
Wawona Frozen Foods Inc.
Organic Daybreak Blend Brand Name: Wawona Frozen Foods 4 lb. plastic bags - 10 bags per case Keep Frozen Item# 684779 UPC: 0 34742 07244 ...
Frozen Food·9,878 affected·Jun 5, 2023
High RiskFDA
Homeocare Laboratories, Inc.
Arnica 7 Cream, net wt 2 oz (56.7g), Manufactured for: Brazmedics, LLC, New York, NY 10021 UPC 8 60208 00181 6
Topical Drugs·2,376 affected·Jun 5, 2023
High RiskFDA
Homeocare Laboratories, Inc.
StellaLife VEGA Oral Care Rinse, 16 fl oz (473 ml) bottles, Coconut, Distributed by: StellaLife, Aventura, FL NDC 69685-113-16
Oral Drugs·16,587 affected·Jun 5, 2023
High RiskFDA
Homeocare Laboratories, Inc.
SnoreStop Naso Spray Bulk, liquid, Distributed by Green Pharma, NDC 61152-199-99
Inhaled / Nasal Drugs·200 affected·Jun 5, 2023
High RiskFDA
Homeocare Laboratories, Inc.
Babelyn Diarrhea Drops Homeopathic Remedy, 0.5 fl. oz. (15 mL) bottles, Distributed by Pharmadel LLC, Georgetown, DE NDC 55758-035-01
Drugs·5,957 affected·Jun 5, 2023
High RiskFDA
Homeocare Laboratories, Inc.
StellaLife VEGA Oral Care Gel, 1 fl oz (30 ml) tubes, Peppermint, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-112-01
Oral Drugs·33,109 affected·Jun 5, 2023
High RiskFDA
Homeocare Laboratories, Inc.
Bebelyn Colic Drops Homeopathic Remedy, 0.5 FL Oz (15 mL) bottles, distributed by Pharmadel LLC Georgetown, DE NDC 55758-036-01
Drugs·5,956 affected·Jun 5, 2023
High RiskFDA
Homeocare Laboratories, Inc.
StellaLife VEGA Oral Care Spray, 1 fl oz (30 ml) bottles, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-101-02
Oral Drugs·40,034 affected·Jun 5, 2023
High RiskFDA
Homeocare Laboratories, Inc.
StellaLife VEGA Oral Care Rinse, 16 fl oz (473 ml) bottles, Peppermint, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-103-16
Oral Drugs·130,762 affected·Jun 5, 2023
High RiskFDA
Homeocare Laboratories, Inc.
DoloEar Earache Drops, 0.50 fl. oz. bottles, Distributed by Pharmadel LLC, Georgetown, DE NDC 55758-001-15
Drugs·12,850 affected·Jun 5, 2023
High RiskFDA
Homeocare Laboratories, Inc.
StellaLife VEGA Oral Care Gel, 1 fl oz (30 ml) tubes, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-102-02
Oral Drugs·38,105 affected·Jun 5, 2023
High RiskFDA
Homeocare Laboratories, Inc.
Kanjo Homeopathic Pain Relief Cream With Arnica, NET WT 2 oz (56.70G), Manufactured For: Acutens, Inc., Sheridan, WY NDC 80551-201-02
Topical Drugs·921 affected·Jun 5, 2023
High RiskFDA
B. Braun Medical, Inc.
Design Options¿ / Epidural anesthesia kit (10 count carton)
Medical Devices·3,560 affected·Jun 5, 2023
CriticalFDA
Datascope Corp.
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33 0998-00-0800-34 0...
Medical Devices·9,174 affected·Jun 5, 2023
High RiskFDA
Ortho-clinical Diagnostics
VITROS Immunodiagnostic Products Troponin I ES Reagent Pack
Diagnostic Devices·4,013 affected·Jun 5, 2023
CriticalFDA
Datascope Corp.
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85
Medical Devices·9,174 affected·Jun 5, 2023
High RiskFDA
Exactech, Inc.
Exactech Ergo Impactor Handle, Catalog #321-09-05.
Medical Devices·784 affected·Jun 5, 2023
High RiskFDA
Siemens Medical Solutions Usa, Inc
Cios Select VA 21 with FD- A Mobile X-ray system intended for use in Operating room, Traumatology, Endoscopy, Intensive Care Station, Ped...
Medical Devices·9 affected·Jun 5, 2023
CriticalFDA
Datascope Corp.
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33 0998-00-0800-34 0...
Medical Devices·9,174 affected·Jun 5, 2023
High RiskFDA
Luminex Corporation
VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022
Medical Devices·114 affected·Jun 5, 2023
CriticalFDA
Datascope Corp.
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85
Medical Devices·9,174 affected·Jun 5, 2023
High RiskFDA
Covidien, Llc
Covidien Cytosponge Cell Collection Device, REF: CYTO-201; and Covidien Cytosponge Cell Collection Kit, REF: CYTO-KIT-USM
Medical Devices·6,902 affected·Jun 2, 2023
High RiskFDA
Beckman Coulter Biomedical Gmbh
Beckman Coulter DxA Automation System, DxA 5000 Fit, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly
Medical Devices·15 affected·Jun 2, 2023
High RiskFDA
Julian's Recipe, Llc
Julian's Recipe Maple & Brown Butter Cauli-Wafels, 7.41 oz.
Dairy·1,786 affected·Jun 1, 2023
High RiskFDA
Houston Pecan Company, Inc
Whole Natural Almonds packaged in 5 pound bag; Whole Blanched Almonds packaged in 5 pound bag; Sliced Blanched Almonds packaged in 5 poun...
Food·0 affected·Jun 1, 2023
High RiskFDA
Houston Pecan Company, Inc
Cranberries Sweetened packaged in 5 pound bags
Produce·0 affected·Jun 1, 2023
High RiskFDA
Houston Pecan Company, Inc
Red Tart Cherries Sweetened packaged in 5 pound bags
Food·0 affected·Jun 1, 2023
High RiskFDA
Julian's Recipe, Llc
Julian's Recipe Original Cauli-Wafels, 7.41 oz.
Food·1,786 affected·Jun 1, 2023
High RiskFDA
Great Lakes Coca-cola Distribution Llc
Fanta Orange 12pk (12, 12 oz. cans) Wrap UPC 0 4900003073 0
Food·14,074 affected·Jun 1, 2023
High RiskFDA
Julian's Recipe, Llc
Julian's Recipe CAULI-WAFEL SANDWICHES TURKEY SAUSAGE & CHEDDAR,
Meat & Poultry·1,786 affected·Jun 1, 2023
High RiskFDA
Houston Pecan Company, Inc
Mixed Nuts Rst & Salted Pecans, Almonds, Cashews, Macadamia Nuts & Hazelnuts packaged in 5 pound bags
Food·0 affected·Jun 1, 2023
High RiskFDA
Houston Pecan Company, Inc
Pitted Prunes, May contain pits or pit fragments packaged in 5 pound bags
Food·0 affected·Jun 1, 2023
High RiskFDA
Houston Pecan Company, Inc
Blanched Hazelnuts packaged in 5 pound bags
Food·0 affected·Jun 1, 2023
High RiskFDA
Houston Pecan Company, Inc
Savory & Sweet Mix Honey Roasted Peanuts, Spicy Peanuts, Smoked Almonds, Toffee Peanuts, Pretzels packaged in 5 pound bags
Food·0 affected·Jun 1, 2023
High RiskFDA
Houston Pecan Company, Inc
Mango Slices, Mango, Cane Sugar, Citric Acid, Calcium Chloride, Sulfur Dioxide packaged in 5 pound bags
Food·0 affected·Jun 1, 2023
High RiskFDA
Houston Pecan Company, Inc
Valencia Orange Slices, Oranges, Sugar, Citric Acid, SO2 packaged in 5 pound bags
Food·0 affected·Jun 1, 2023
High RiskFDA
Amin Trading Agency Llc
Everest Garam Masala, 100 grams, Packaged in paper cartons. 120 cartons per case
Food·300 affected·Jun 1, 2023
High RiskFDA
Houston Pecan Company, Inc
Walnut Halves packaged in 5 pound bag; Walnuts Medium Pices packaged in 5 pound bags; Walnuts Halves & Large Pieces packaged in 5 pound bags
Food·0 affected·Jun 1, 2023
High RiskFDA
Houston Pecan Company, Inc
Medium Pecan Pieces 5 pound bag; Mammoth Pecan Halves 5 pound bag; Jr. Mammoth Pecan Halves 5 pound bag
Food·0 affected·Jun 1, 2023
High RiskFDA
Houston Pecan Company, Inc
Cashews Whole Raw packaged in 5 pound bags; Cashew Pieces packaged in 5 pound bags; Cashews Roasted NO SALT packaged in 5 pound bags
Food·0 affected·Jun 1, 2023
High RiskFDA
Houston Pecan Company, Inc
Turkish Apricots Sulfur Dioxide Added packaged in 5 pound bags; Diced Apricots Sulfur Dioxide Added packaged in 5 pound bags;
Food·0 affected·Jun 1, 2023
High RiskFDA
Amin Trading Agency Llc
Everest Sambhar Masala, 100 grams, Packaged in paper cartons. 120 cartons per case
Food·270 affected·Jun 1, 2023
High RiskFDA
Houston Pecan Company, Inc
Pine Nuts packaged in 5 pound bags
Food·0 affected·Jun 1, 2023
High RiskFDA
Houston Pecan Company, Inc
Apple Rings Sulfur Dioxide Added packaged in 5 pound bags; Apple Rings, 1/2 pound bag
Food·0 affected·Jun 1, 2023
High RiskFDA
Houston Pecan Company, Inc
Shredded Coconut Sulfur Dioxide added packaged in 5 pound bags
Food·0 affected·Jun 1, 2023