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High RiskFDA
Sprayology
Body Balance, Homeopathic Oral Spray 1.38 fl. oz (41 mL). Manufactured by Sprayology Gaithersburg, MD 20879. NDC 61096-0039-1
Oral Drugs·2,595 affected·Oct 9, 2018
High RiskFDA
Sprayology
PMS Support, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0031-1
Oral Drugs·647 affected·Oct 9, 2018
High RiskFDA
Sprayology
ImmunoBooster, Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by Sprayology Gaithersburg, MD 20879. NDC 61096-0038-1
Oral Drugs·2,837 affected·Oct 9, 2018
High RiskFDA
Sprayology
Man Power, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0025-1 and Tester ND...
Oral Drugs·830 affected·Oct 9, 2018
High RiskFDA
Sprayology
Arnica Power, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879.NDC 61096-0032-1
Oral Drugs·3,531 affected·Oct 9, 2018
High RiskFDA
Sprayology
Bone Builder, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0012-1 and Tester...
Oral Drugs·731 affected·Oct 9, 2018
High RiskFDA
Theragenics Corporation
Theragenics Applicator Needle (18g x 20cm) The device is comprised four basic elements; a wire stylus with plastic handle, a plastic n...
Medical Devices·480 affected·Oct 9, 2018
High RiskFDA
Forager Project Llc
Forager Project Organic Protein Plant Shake Nuts & Vanilla 12 fl oz. UPC: 8 14558 02038 6
Food·2,256 affected·Oct 8, 2018
High RiskFDA
Icu Medical Inc
0.9% Sodium Chloride Injection, USP Rx Only a) 250 mL NDC 0409-7983-02; b) 150 mL NDC 0409-7983-61; c) 50 mL NDC 0409-7984-36; d) 100 mL ...
Injectable Drugs·2,580,448 affected·Oct 8, 2018
High RiskFDA
Icu Medical Inc
5% Dextrose Injection, USP, Rx Only, a) 25 mL NDC 0409-7923-20; b) 250 mL NDC 0409-7922-02, Hospira, Inc. Lake Forest, IL 60045
Injectable Drugs·372,912 affected·Oct 8, 2018
High RiskFDA
Akorn, Inc.
Gentamicin Sulfate Ophthalmic Solution, USP 0.3%, 5 mL dropper bottle, Rx Only, Manufactured by: Akorn, Inc. Lake Forest, IL 60045, NDC 1...
Ophthalmic Drugs·149,159 affected·Oct 8, 2018
High RiskFDA
Stryker Medical Division Of Stryker Corporation
The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option
Medical Devices·20,030 affected·Oct 8, 2018
High RiskFDA
Voluntis
Insulia Diabetes Management Companion
Diabetes Devices·14 affected·Oct 8, 2018
High RiskFDA
Lupin Somerset
Fluocinolone Acetonide Topical Solution, USP 0.01%, 60ml Bottle, Manufactured for: Lupin Pharmaceutical, Inc. Baltimore, MD 21202 Manufac...
Topical Drugs·2,712 affected·Oct 5, 2018
High RiskFDA
Icu Medical, Inc.
Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 unit per Cavity #2-4"x9" Cav/20 pieces per case R1-15645
Medical Devices·25,640 affected·Oct 5, 2018
High RiskFDA
Ohmeda Medical
Giraffe Omnibed - Product Usage: The OmniBed is a combination of an infant incubator and an infant warmer. The device can be operated as ...
Respiratory Devices·0 affected·Oct 5, 2018
High RiskFDA
Covidien Llc
Parietex Composite Parastomal Mesh (Product Number PCOPM15 / PCOPM20) Product Usage: The PCOPM15 and PCOPM20 reorder codes are circul...
Surgical Devices·7,333 affected·Oct 5, 2018
High RiskFDA
Icu Medical, Inc.
Thermoset Room Temperature Closed Loop Injectate Delivery System. 1 unit per Cavity #3 Cavity Deep/20 pieces per case R1-6090
Medical Devices·27,250 affected·Oct 5, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc.
EVO Excel, Emission Computed Tomographic System, Material Number 10910501
Medical Devices·264 affected·Oct 5, 2018
High RiskFDA
Icu Medical, Inc.
Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 unit per Cavity #6x12x2.6 Cav/10 pieces per case R1-6090
Medical Devices·1,760 affected·Oct 5, 2018
High RiskFDA
Campofresco Corp.
Orange plus Citrus Beverage from Concentrate
Beverages·1,010 affected·Oct 4, 2018
High RiskFDA
Silver Star Brands
Healthful Naturals DizziFree Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906. NDC 68703-2...
Oral Drugs·247 affected·Oct 3, 2018
High RiskFDA
Pfizer Inc.
Magnesium Sulfate in Water for Injection (0.325 mEq Mg++/mL) 40 mg/mL, 20 g Total, 500 mL Single-Dose Container bag, Rx only, Hospira, In...
Injectable Drugs·94,752 affected·Oct 3, 2018
High RiskFDA
Silver Star Brands
Healthful Naturals Leg Cramp Support Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906 NDC ...
Oral Drugs·247 affected·Oct 3, 2018
High RiskFDA
Jubilant Cadista Pharmaceuticals, Inc.
Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg*, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd., Roorkee - 24...
Oral Drugs·158,466 affected·Oct 2, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail 125 Deg 12x165mm, Item Number 816712165 The Affixus Hip Fracture Nail System, comprised of short and long n...
Medical Devices·2,163 affected·Oct 2, 2018
High RiskFDA
Arrow International Inc
AF w/AS 550 x 1-14ML/HR CPNB, Product code MVBXL- CPNB, Arrow AutoFuser Disposable Pain Control Pump
Medical Devices·38 affected·Oct 2, 2018
High RiskFDA
Arrow International Inc
AF w/AS 550 x 1-14 ml/hr, 5ml30 LOCPNB, Product code MVBX30XLCPNB, Arrow AutoFuser Disposable Pain Control Pump
Medical Devices·2 affected·Oct 2, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail 130 Deg 10x165mm, Item Number 816810165 The Affixus Hip Fracture Nail System, comprised of short and long n...
Medical Devices·2,163 affected·Oct 2, 2018
High RiskFDA
Arrow International Inc
AF 550 x 5ML/H 6" CATH, 4.5" IN, Product code MC0050XLSK5 CP, Arrow AutoFuser Disposable Pain Control Pump
Medical Devices·1 affected·Oct 2, 2018
High RiskFDA
Arrow International Inc
AF 550 x 5ML/H 6" DUAL CATHS, 4.5", Product code MC0050XLYK5 CP, Arrow AutoFuser Disposable Pain Control Pump
Medical Devices·8 affected·Oct 2, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Left 130 Deg 11x300mm, Item Number 814611300 The Affixus Hip Fracture Nail System, comprised of short and l...
Medical Devices·2,163 affected·Oct 2, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Left 125 Deg 9x165mm, Item Number 816709165 The Affixus Hip Fracture Nail System, comprised of short and lo...
Medical Devices·2,163 affected·Oct 2, 2018
High RiskFDA
Arrow International Inc
AF w/AS 550 x 1-14ML/HR 2ML-30LO CPNB, Product code MVBT30XL CPNB, Arrow AutoFuser Disposable Pain Control Pump
Medical Devices·1 affected·Oct 2, 2018
High RiskFDA
Arrow International Inc
AF w/AS 550 x 1-14ML/HR 2ML-15LO CPNB, Product code MVBT15XL-CPNB, Arrow AutoFuser Disposable Pain Control Pump
Medical Devices·19 affected·Oct 2, 2018
High RiskFDA
Arrow International Inc
AF w/AS 550 x 1-14ML/HR 5ML-60LO CPNB, Product code MVBX60XL CPNB, Arrow AutoFuser Disposable Pain Control Pump
Medical Devices·1 affected·Oct 2, 2018
High RiskFDA
Arrow International Inc
AF550x5ML/H 2ML 60LO 6" DUAL CATHS, 4.5", Product MT5060XLYK5 CP, Arrow AutoFuser Disposable Pain Control Pump
Medical Devices·3 affected·Oct 2, 2018
High RiskFDA
Arrow International Inc
AF 550 x 5ML/HR 2ML 60LO CPNB, Product code MT5060XL CPNB, Arrow AutoFuser Disposable Pain Control Pump
Medical Devices·5 affected·Oct 2, 2018
High RiskFDA
Arrow International Inc
AF w/AS 550 x 0.5-7 ml,w/Y site,DL CPNB, Product code MVAXL2Y CPNB, Arrow AutoFuser Disposable Pain Control Pump
Medical Devices·26 affected·Oct 2, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Left 125 Deg 11x300mm, Item Number 814411300 The Affixus Hip Fracture Nail System, comprised of short and l...
Medical Devices·2,163 affected·Oct 2, 2018
High RiskFDA
Pfizer Inc.
Thermacare HeatWraps Menstrual a) UPC 0573302002 b) UPC 0573302044 Product Usage: Provides heat therapy for temporary relief of min...
Medical Devices·293,880 affected·Oct 2, 2018
High RiskFDA
Arrow International Inc
AF 550x8ML/H 2ML 15LO 8.7" DUAL CATHS, 4, Product code MT8015XLYK10 CP, Arrow AutoFuser Disposable Pain Control Pump
Medical Devices·8 affected·Oct 2, 2018
High RiskFDA
Arrow International Inc
0F 550 x 8ML/HR 2ML 60LO CPNB, Product code MT8060XL CPNB, Arrow AutoFuser Disposable Pain Control Pump
Medical Devices·5 affected·Oct 2, 2018
High RiskFDA
Arrow International Inc
AF 550 x 8ML/HR 2ML 15LO CPNBMT8015XL CP, Product code MT8015XL CPNB, Arrow AutoFuser Disposable Pain Control Pump
Medical Devices·1 affected·Oct 2, 2018
High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Medtronic CareLink Encore 29901 Programmer
Medical Devices·4,072 affected·Oct 2, 2018
High RiskFDA
Pfizer Inc.
Thermacare Muscle Pain Therapy HeatWraps: a) UPC 0573301314 b) UPC 0573301303 Product Usage: Provides heat therapy for temporary re...
Medical Devices·119,232 affected·Oct 2, 2018
High RiskFDA
Randox Laboratories Ltd.
Liquid Cardiac Control, CQ5053
Cardiac Devices·2,108 affected·Oct 2, 2018
High RiskFDA
Nutranext Business Llc
Internal Cleansing Kit Peppermint
Food·2,387 affected·Oct 1, 2018