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High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Medtronic Power Supply 26907, Medtronic CareLink Encore(TM) 29901 Programmer
Medical Devices·731 affected·Jan 17, 2019
High RiskFDA
Djo, Llc
Aircast REF 3011 - PL RX only VF-PL Sterile Cuff Pkg., Lot# 418003, Expiration Date: 2020 -12 - 31, Made in Mexico, DJO, LLC.
Medical Devices·9 affected·Jan 17, 2019
CriticalFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Medtronic implantable pulse generator: ATTESTA L DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR): (a) Model Number ATDR...
Medical Implants·9,915 affected·Jan 17, 2019
CriticalFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
vitatron (implantable pulse generator): (a) A-series, Model Numbers: A30A1, A60A1 (b) E-series, Model Numbers: E50A1, E60A1 (c) G-se...
Medical Implants·47,086 affected·Jan 17, 2019
High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
MEDTRONIC CARELINK 2090 programmer
Medical Devices·33,007 affected·Jan 17, 2019
High RiskFDA
Ventura Foods Llc
Sysco Classic Liquid Margarine; 2 x 17.5 lb. plastic containers; 99961WFS
Food·546 affected·Jan 16, 2019
CriticalFDA
Puratos Corporation
Tegral Satin Gold CL Cr¿me Cake, packaged in 50 lb. bag.
Bakery & Grains·25,700 affected·Jan 16, 2019
High RiskFDA
Rx Pak Division Of Mckesson Corporation
Docusate Sodium, 100mg softgels, packaged in 10 x 10 unit dose blister cards, For institutional use only, Mfg by: Aenova Holding GmBh, Mi...
Drugs·29,622 affected·Jan 16, 2019
High RiskFDA
Krs Global Biotechnology, Inc
NORepinephrine 16 mg added to 0.9% Sodium Chloride (PF), 16 mg / 250 mL, 250 mL IV bag, Rx only, KRS Global Biotechnology: 791 Park of C...
Injectable Drugs·190 affected·Jan 16, 2019
High RiskFDA
Krs Global Biotechnology, Inc
NORepinephrine 4 mg added to 5% Dextrose 250 mL Bag (PF), 4 mg / 250 mL, 250 mL IV bag, Rx only, KRS Global Biotechnology: 791 Park of C...
Injectable Drugs·433 affected·Jan 16, 2019
RecallFDA
Carolina Liquid Chemistries
CAROLINA(R) LIQUID CHEMISTRIES CORP. ETHA RGT. KIT, IVD, REF ST321
Medical Devices·14 affected·Jan 16, 2019
High RiskFDA
Polymer Technology Systems, Inc.
CHOL+HDL+GLU test strips, REF 2412
Medical Devices·67,643 affected·Jan 16, 2019
High RiskFDA
Polymer Technology Systems, Inc.
Lipid Panel test strips (as a component of smart bundles), REF 2729, also private labeled under Henry Schein as REF 570-0412
Medical Devices·67,643 affected·Jan 16, 2019
RecallFDA
Carolina Liquid Chemistries
CAROLINA(R) LIQUID CHEMISTRIES CORP. ETHA RGT. KIT, IVD, REF ST321
Medical Devices·20 affected·Jan 16, 2019
CriticalFDA
Ottogi America Inc
Ottogi Ppushu Ppushu BBQ Flavor 3.17oz x 40ea Item #21503007 Manufactured by: Ottogi Ramyon Co. Ltd. Distributed by: Ottogi America, ...
Food·1,594,338 affected·Jan 15, 2019
CriticalFDA
Ottogi America Inc
Ottogi Spicy Seafood flavor Udon Odongtong 5PK 1lb 5.16oz x 8pk Item #32142410 Manufactured by: Ottogi Ramyon Co. Ltd. Distributed by...
Seafood·1,594,338 affected·Jan 15, 2019
CriticalFDA
Ottogi America Inc
Ottogi Ramen Sari (Extra Noodle) 3.88oz x 48ea Item #21101009 Manufactured by: Ottogi Ramyon Co. Ltd. Distributed by: Ottogi America,...
Food·1,594,338 affected·Jan 15, 2019
CriticalFDA
Ottogi America Inc
Ottogi Ppushu Ppushu Grilled Chicken Flavor 3.17oz x 40ea Item #21503006 Manufactured by: Ottogi Ramyon Co. Ltd. Distributed by: Otto...
Meat & Poultry·1,594,338 affected·Jan 15, 2019
CriticalFDA
Ottogi America Inc
Ottogi BuckwheatChilli Noodle PK 1lb 6.93oz x 8pk Item #32143061 Manufactured by: Ottogi Ramyon Co. Ltd. Distributed by: Ottogi Ameri...
Food·1,594,338 affected·Jan 15, 2019
CriticalFDA
Ottogi America Inc
Ottogi Jin Jjambbong Spicy Seafood Noodle 4.58 oz x 4 ea Item #32142443 Manufactured by: Ottogi Ramyon Co. Ltd. Distributed by: Ottog...
Seafood·1,594,338 affected·Jan 15, 2019
CriticalFDA
Ottogi America Inc
Ottogi Jin Ramen Mild Bowl, 5PK 3.88oz x 12ea, 1 lb 5.16oz x 8pk, 4.23oz x 12ea, cup 2.29 oz x 6 cup Item #21309025, 32142401, 21501201...
Food·1,594,338 affected·Jan 15, 2019
CriticalFDA
Ottogi America Inc
Ottogi Beijing Spicy Seafood Noodle 5PK 1lb 5.16oz x 8pk Item #32142408 Manufactured by: Ottogi Ramyon Co. Ltd. Distributed by: Ottog...
Seafood·1,594,338 affected·Jan 15, 2019
CriticalFDA
Ottogi America Inc
Ottogi Jjajang Bokki (Bowl) 4.23oz x 12ea Item #21502157 Manufactured by: Ottogi Ramyon Co. Ltd. Distributed by: Ottogi America, Inc....
Food·1,594,338 affected·Jan 15, 2019
CriticalFDA
Ottogi America Inc
Ottogi Beijing JJajang Noodle 5PK 1lb 7.81oz x 8pk Item #32142407 Manufactured by: Ottogi Ramyon Co. Ltd. Distributed by: Ottogi Amer...
Food·1,594,338 affected·Jan 15, 2019
CriticalFDA
Ottogi America Inc
Ottogi Spicy Seafood Flavor Udon Odongtong (Bowl) 3.53oz x 12ea Item #21502162 Manufactured by: Ottogi Ramyon Co. Ltd. Distributed by...
Seafood·1,594,338 affected·Jan 15, 2019
CriticalFDA
Ottogi America Inc
Ottogi Snack Ramen 5PK, Cup 1lb 3.05oz x 8pk, 2.18oz x 6ea Item #21501281, 21502161 Manufactured by: Ottogi Ramyon Co. Ltd. Distribut...
Snacks & Candy·1,594,338 affected·Jan 15, 2019
CriticalFDA
Ottogi America Inc
Ottogi Yeul Ramen (Bowl) 4.06oz x 12ea Item #21305007 Manufactured by: Ottogi Ramyon Co. Ltd. Distributed by: Ottogi America, Inc. 16...
Food·1,594,338 affected·Jan 15, 2019
CriticalFDA
Ottogi America Inc
Ottogi Ppushu Ppushu Spicy Flavor 3.17oz x 40ea Item #21503008 Manufactured by: Ottogi Ramyon Co. Ltd. Distributed by: Ottogi America...
Food·1,594,338 affected·Jan 15, 2019
High RiskFDA
Tris Pharma Inc.
infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, Dye-Free Berry Flavor, 1 FL OZ (30 mL) bottle...
Oral Drugs·35,328 affected·Jan 15, 2019
High RiskFDA
Tris Pharma Inc.
Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye Free, Non-staining Berry Flavor, 1 FL OZ...
Oral Drugs·35,280 affected·Jan 15, 2019
High RiskFDA
Tris Pharma Inc.
Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye Free, Non-staining Berry Flavor, 0.5 FL ...
Oral Drugs·46,080 affected·Jan 15, 2019
High RiskFDA
Lupin Somerset
Fluocinolone Acetonide Topical Solution, USP, 0.01 %, 60 mL bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD...
Topical Drugs·24,180 affected·Jan 15, 2019
High RiskFDA
Advanced Pharma Inc.
HEPERAIN 50 mg/50 mL (1mg/mL) Injectable Solution, Heparin Sodium 0.45% Sodium Chloride QS Heparin 50 Units 50 mL, Sterile single use syr...
Injectable Drugs·160 affected·Jan 15, 2019
High RiskFDA
Dr. Reddy's Laboratories, Inc.
Ezetimibe and Simvastatin Tablets 10mg/80 mg, 1000-count bottles, Rx only, Manufactured by: Teva Pharmaceuticals Ind. Ltd. Jerusalem, 9...
Oral Drugs·118 affected·Jan 15, 2019
High RiskFDA
Westmed, Inc.
Neo-Vent Infant T-Piece Resuscitation Circuit With Infant Mask; Circuit for use on compatible Infant Resuscitators. 15mm OD x 10mm ID con...
Medical Devices·35 affected·Jan 15, 2019
High RiskFDA
Miami Device Solutions, Llc.
Proximal Humerus Plate, 8 holes, Right, REF MDS130108R - Product Usage: The Proximal Humerus Plating System consists of plates, screws, a...
Medical Implants·15 affected·Jan 15, 2019
High RiskFDA
Westmed, Inc.
Neo-Vent Infant T-Piece Resuscitation Circuit;Circuit for use on compatible Infant Resuscitators. 15mm OD x 10mm ID connector; REF 0415, ...
Medical Devices·625 affected·Jan 15, 2019
High RiskFDA
Century Snacks Llc
Snak Club Praline Pecans Made With Cane Sugar NET Wt. 2.25 oz (64 g) Produced By: Century Snack Commerce, CA 90040 centurysnacks.com
Snacks & Candy·25 affected·Jan 14, 2019
High RiskFDA
Shimadzu Medical Systems Usa Com
BRANSIST safire Product Usage: DIGITAL ANGIOGRAPHY SYSTEM This system is intended to be used for radiologic visualization of the hear...
Cardiac Devices·8 affected·Jan 14, 2019
High RiskFDA
Arthrex, Inc.
Arthrex Burr, Oval, 12 Flute, 5.5 mm x 13 cm (AR-8550OBT) These devices are indicated for resection of soft and osseous tissues in bot...
Medical Devices·2,324 affected·Jan 14, 2019
High RiskFDA
Shimadzu Medical Systems Usa Com
TRINIAS for diagnostic imaging and interventional procedures in cardiac angiography, neurovascular angiography, abdominal angiography, pe...
Cardiac Devices·13 affected·Jan 14, 2019
High RiskFDA
Becton Dickinson & Co.
BD MAX Enteric Bacterial Panel -For In Vitro Diagnostic Use with the BD MAX System Catalog Number: 442963 The BD MAX Enteric Bacteria...
Diagnostic Devices·1,583 affected·Jan 14, 2019
RecallFDA
Teleflex Medical
RUSCH Urinary Drainage bag, 2000mlm REF 390060 urine collection device
Medical Devices·76,725 affected·Jan 14, 2019
High RiskFDA
Nutrafuels, Inc.
CTFO Pain Relief Oral Spray with pure CBD Hemp Oil isolate Dietary Supplement, 1oz/30ml.
Supplements·840 affected·Jan 11, 2019
CriticalFDA
Mccormick & Company, Inc. - Flavor Manufacturing Center
El Guapo Pasilla-Ancho Chile Pods 2oz, 7.5oz, 11oz
Food·2 affected·Jan 11, 2019
High RiskFDA
Nutrafuels, Inc.
CTFO Sleep Support Oral Spray with pure CBD Hemp Oil isolate Dietary Supplement, 1oz/30ml.
Supplements·676 affected·Jan 11, 2019
High RiskFDA
Nutrafuels, Inc.
CTFO Weight Loss Oral Spray with pure CBD Hemp Oil isolate Dietary Supplement, 1oz/30ml.
Supplements·1,011 affected·Jan 11, 2019
RecallFDA
Oxalis Labs
Clobetasol Propionate Topical Solution USP, 0.05% w/w, 50 mL bottle, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536 M...
Topical Drugs·53,358 affected·Jan 11, 2019