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High RiskFDA
S. Martinelli Harvest Facility
Martinelli's Gold Medal 100% Apple Juice 10 oz. glass bottles, 24 units per case Apple shaped glass bottles Shelf stable UPC: 041244000098
Beverages·2,387 affected·Jun 12, 2023
High RiskFDA
Supplement Manufacturing Partner, Inc.
Havasu Beetroot Powder, 11.5 oz.
Food·1,501 affected·Jun 12, 2023
High RiskFDA
Ferring Pharmaceuticals Inc
Endometrin (progesterone) Vaginal Insert 100mg, packaged in a carton of 21 vaginal inserts with 21 disposable vaginal applicators, Manufa...
Drugs·0 affected·Jun 12, 2023
High RiskFDA
Philips Medical Systems Nederland B.v.
Azurion 7 M20. X-ray Image guided Therapy System.
Medical Devices·648 affected·Jun 12, 2023
High RiskFDA
Philips North America
Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Elition X)
Medical Devices·601 affected·Jun 12, 2023
High RiskFDA
Tornier, Inc
AEQUALIS FLEX REVIVE Assembly Screw 0mm Short, Model Number ARS655118
Medical Devices·55 affected·Jun 12, 2023
High RiskFDA
Intuitive Surgical, Inc.
da Vinci Xi/X Tip-Up Fenestrated Grasper, REF: 470347, VER: 12
Medical Devices·46,033 affected·Jun 12, 2023
High RiskFDA
Philips North America
MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7700)
Medical Devices·601 affected·Jun 12, 2023
High RiskFDA
Philips North America
Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Elition X)
Medical Devices·640 affected·Jun 12, 2023
High RiskFDA
Tornier, Inc
AEQUALIS FLEX REVIVE Assembly Screw 0mm, Model Number ARS655101
Medical Devices·55 affected·Jun 12, 2023
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD10 and FD20. X-ray Imaging System.
Medical Devices·648 affected·Jun 12, 2023
High RiskFDA
Philips North America
MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7700)
Medical Devices·640 affected·Jun 12, 2023
High RiskFDA
Pepsico Beverages & Foods
Pearl Milling Company Self-Rising Yellow Corn Meal Mix Net Wt 80 oz (5 lb) UPC 3000057380 packaged in paper bag with printed label
Food·91,760 affected·Jun 9, 2023
High RiskFDA
Pepsico Beverages & Foods
Pearl Milling Company Self-Rising White Corn Meal Mix Net Wt 80 oz (5 lb) UPC 3000057381 packaged in paper bag with printed label and Pea...
Food·412,760 affected·Jun 9, 2023
High RiskFDA
Botanas Michoacanas
Churritos Corn Flour sticks, shelf stable, 6 months shelf life, packed in a rectangular shape clear polypropylene bag with net wt.11 oz (...
Beverages·40 affected·Jun 8, 2023
High RiskFDA
Compass Usa
Fresh To You Chicken Filet Sandwich. MGF0635. Net Wt. 8oz. Perishable - Keep Refrigerated. Manufactured By MG Foods, Oak Creek, WI ...
Meat & Poultry·2,354 affected·Jun 8, 2023
High RiskFDA
Olympus Corporation Of The Americas
HF Resection Electrodes - HF resection electrodes are part of a resectoscope system for endoscopic diagnosis and treatment in urological ...
Medical Devices·62,704 affected·Jun 8, 2023
High RiskFDA
Becton Dickinson & Co.
BD Synapsys Informatics Solution, Catalog Number 444150
Medical Devices·102 affected·Jun 8, 2023
High RiskFDA
Argon Medical Devices, Inc
Argon Medical Devices, REF 352506070E, Option Elite Retrievable Vena Cava Filter, Suitable of Jugular or Femoral Delivery, STERILEO, RxOn...
Medical Devices·3 affected·Jun 8, 2023
High RiskFDA
Microvention Inc.
FRED Flow Re-Direction Endoluminal Device, REF: FRED3507-PMA, FRED3511, FRED3511-PMA, FRED3516-CA, FRED3516-PMA, FRED3524, FRED3524-CA, F...
Medical Devices·474 affected·Jun 7, 2023
High RiskFDA
Ptw-freiburg
BeamAdjust software Version 2.3.3 Ref: S080032 The following devices are affected when a relative calibration is performed using Array...
Medical Devices·42 affected·Jun 7, 2023
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Medtronic Catalyft LS Expandable Interbody System Implant Kit, Anterior Standalone Cage, REF SPS03188, spinal implant kit
Medical Implants·12 affected·Jun 6, 2023
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981027722, spinal implant
Medical Implants·10 affected·Jun 6, 2023
High RiskFDA
Neurologica Corporation
OmniTom/OmniTom Elite- X-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, primarily head and ne...
Medical Devices·48 affected·Jun 6, 2023
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
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
High RiskFDA
Ortho-clinical Diagnostics
VITROS Immunodiagnostic Products Troponin I ES Reagent Pack
Diagnostic Devices·4,013 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
High RiskFDA
Luminex Corporation
VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022
Medical Devices·114 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