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CriticalFDA
Abbott Vascular
NC TREK Coronary Dilatation Catheter, REF 1012453-12 Rx Only, NC TREK RX 4.00 X 12MM BDC The NC TREK RX Coronary Dilatation Catheter ...
Medical Implants·39,687 affected·Jan 29, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Honeywell Pressure Transducer- Part Number: 370506-22. It is a component used in 2008T, Common Name: Hemodialysis Delivery System; 2008T ...
Medical Devices·3,561 affected·Jan 29, 2020
High RiskFDA
Southern Sisters Gourmet
Southern Sisters Gourmet Cheddar Garlic Biscuits, Net Wt 16 oz (453.6 g)
Food·0 affected·Jan 28, 2020
High RiskFDA
Southern Sisters Gourmet
Southern Sisters Gourmet Apple Crisp mix
Food·0 affected·Jan 28, 2020
High RiskFDA
Southern Sisters Gourmet
Southern Sisters Gourmet Butter Pecan Cheeseball mix, Net Wt 358.919 g, 16 servings
Dairy·0 affected·Jan 28, 2020
High RiskFDA
Southern Sisters Gourmet
Southern Sisters Gourmet Shrimp and Stone-Ground Grits, Seasoning - Net Wt: 12 g, Grits - Wt: 8 ounces
Seafood·0 affected·Jan 28, 2020
High RiskFDA
Il Nuts
Yossef Roasting Co. Handcrafted Nuts Watermelon Seeds; 7oz.
Beverages·50 affected·Jan 28, 2020
High RiskFDA
Southern Sisters Gourmet
Southern Sisters Gourmet Taco Soup, Net Wt- Pkg 1: 191.65 g, Pkg 2: 8 ounces
Food·0 affected·Jan 28, 2020
High RiskFDA
Southern Sisters Gourmet
Southern Sisters Gourmet Crab Cake Mix, Net Wt 96 g (3.38 oz)
Seafood·0 affected·Jan 28, 2020
High RiskFDA
Southern Sisters Gourmet
Southern Sisters Gourmet Oven Fried Chicken, Net Wt 2.6 oz/75.6 g
Meat & Poultry·0 affected·Jan 28, 2020
RecallFDA
Corinthian Trading Inc
UNCOOKED SWEET POTATO CRUSTED ALASKA POLLOCK NUGGETS 5 LBS 2.26KG DISTRIBUTED BY CORINTHIAN FOODS ST. SIMONS ISLAND, GA 31622 UPC 8 50008...
Food·682 affected·Jan 28, 2020
CriticalFDA
Mccormick & Company, Inc. - Flavor Manufacturing Center
Sunny Select Au Jus Gravy Mix 1 OZ pouch (24 pouches per case)
Food·127 affected·Jan 28, 2020
High RiskFDA
Ncs Healthcare Of Kentucky Inc
Glycopyrrolate Tabs, USP, 1 mg, 30-count unit dose blister card, FOR INSTITUTIONAL USE ONLY, Rx Only, Packaged by Vangard, Glasgow, KY 42...
Drugs·6,929 affected·Jan 28, 2020
High RiskFDA
Teva Pharmaceuticals Usa
Tramadol Hydrochloride Tablets USP CIV, 50 mg, packaged in a) 100-count bottles (NDC 0093-0058-01), b) 500-count bottles (NDC 0093-0058-...
Injectable Drugs·2,044,497 affected·Jan 28, 2020
High RiskFDA
B And A Trading Corporation
Kushim Tablets (Gushim) 45-count packages, Label in foreign language
Oral Drugs·40 affected·Jan 28, 2020
High RiskFDA
Graviti Pharmaceuticals Private Limited
Atorvastatin Calcium Tablets, USP, 10 mg*, 90-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009 USA; Man...
Oral Drugs·29,056 affected·Jan 28, 2020
High RiskFDA
Breas Medical, Inc.
Protective Cover Vivo 55/65 (Used for Vivo 50/65), Part No. 006344. It is an accessory (i.e. protective cover) for the Vivo 50 and Vivo 6...
Respiratory Devices·629 affected·Jan 28, 2020
High RiskFDA
Smith & Nephew, Inc.
JOURNEY II UNI RESECTION PREP TRIAL, LEFT MEDIAL/ RIGHT LATERAL - Product Usage: The JOURNEY II Uni Resection Prep Trial is a reusable su...
Surgical Devices·200 affected·Jan 28, 2020
High RiskFDA
Medtronic, Plc
McGRATH X3 Disposable Laryngoscope Blades-used with the McGRATH MAC Video Laryngoscope to aid the intubation of the trachea Code: X3-...
Medical Devices·109,897 affected·Jan 28, 2020
High RiskFDA
Smith & Nephew, Inc.
JOURNEY II UNI RESECTION PREP TRIAL, RIGHT MEDIAL/ LEFT LATERAL - Product Usage: The JOURNEY II Uni Resection Prep Trial is a reusable su...
Surgical Devices·195 affected·Jan 28, 2020
High RiskFDA
Medicrea International
Pedicle Screws, multiple sizes, Article Nos. B36004525 B36004530 B36004535 B36004540 B36004545 B36004550 B36004555 B36005530 B...
Medical Devices·3,529 affected·Jan 28, 2020
High RiskFDA
Qiagen Sciences Llc
QIAGEN Rotor Gene Q Software version 2.3.4. Real-time PCR analyzer designed for rapid thermalcycling and real-time detection of PCR ass...
Diagnostic Devices·11,418 affected·Jan 28, 2020
High RiskFDA
Teva Pharmaceuticals Usa
Desmopressin Acetate Tablets, 0.1 mg, 100-count bottle, Rx Only, Manufactured by: Actavis Laboratories, Inc. Fort Lauderdale, FL 33314 US...
Oral Drugs·22,868 affected·Jan 27, 2020
High RiskFDA
Teva Pharmaceuticals Usa
Methylphenidate hydrochloride Extended-Release ablets USP (CII), 27 mg, 100-count bottle, Rx only, Teva Pharmaceuticals USA, Inc., North ...
Drugs·17,436 affected·Jan 27, 2020
High RiskFDA
Teva Pharmaceuticals Usa
Desmopressin Acetate Tablets, 0.2 mg, 100-count bottle, Rx Only, Manufactured by: Actavis Laboratories, Inc. Fort Lauderdale, FL 33314 US...
Oral Drugs·69,012 affected·Jan 27, 2020
High RiskFDA
Teva Pharmaceuticals Usa
Methylphenidate hydrochloride Extended-Release ablets USP (CII), 18 mg, 100-count bottle, Rx only, Teva Pharmaceuticals USA, Inc., North ...
Drugs·0 affected·Jan 27, 2020
High RiskFDA
Fridababy Llc
fridababy SmileFrida the TOOTHHUGGER 18+ months Triple Angle Brush Cleans All Sides at Once
Medical Devices·480,144 affected·Jan 27, 2020
High RiskFDA
Exactech, Inc.
Truliant Splined Stem Extension, 18mm x 120mm - Product Usage: The devices are used in a cemented total knee prosthesis system, which pro...
Medical Implants·4 affected·Jan 27, 2020
High RiskFDA
Losurdo Foods, Inc.
1. Boars Head Fresh Mozzarella Ball, 8oz. 2. Losurdo Fresh Caprese Log Mozzarella, 6 lbs. 3. Piancone Fresh Mozzarella Loaf, 3 lbs....
Food·474 affected·Jan 24, 2020
CriticalFDA
Quesos La Ricura, Ltd.
QUESOS LA RICURA brand Queso Cotija; Cotija Cheese; AGED OVER 60 DAYS; Ingredients: Raw Milk, Salt, Enzyme and Cultures; KEEP REFRIGERATE...
Dairy·640 affected·Jan 24, 2020
High RiskFDA
Ascend Laboratories Llc
Olmesartan Medoxomil Tablets 20 mg, Rx Only, 90 Tablets per Bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013 INDIA, Dis...
Oral Drugs·192 affected·Jan 24, 2020
High RiskFDA
Breckenridge Pharmaceutical, Inc
Solifenacin Succinate Tablets, 10 mg, packaged in a) 30-count bottles (NDC 51991-894-33) and b) 90-count bottles (NDC 51991-894-90), Dis...
Oral Drugs·11 affected·Jan 24, 2020
High RiskFDA
Breckenridge Pharmaceutical, Inc
Solifenacin Succinate Tablets, 5mg, packaged in a) 30-count bottles (NDC 51991-893-33) and b) 90-count bottles (NDC 51991-893-90) Distrib...
Oral Drugs·11,250 affected·Jan 24, 2020
RecallFDA
Macleods Pharma Usa Inc
Pioglitazone and Metformin Hydrochloride Tablets, USP 15 mg/500 mg, Rx Only, 60-count bottle, Manufactured for Macleods Pharma USA, Inc. ...
Oral Drugs·4,694 affected·Jan 24, 2020
High RiskFDA
Abbott Gmbh & Co. Kg
LN 3R70-01; software version 2.6.2 and earlier. The software is used with the Alinity i (LN 03R65-01) processing module and the Alinity ...
Medical Devices·2,676 affected·Jan 24, 2020
High RiskFDA
Ardent Mills Llc
Kroger Unbleached All Purpose Enriched Flour, 5 lb. bag. Bar code: 011110861660
Food·780 affected·Jan 23, 2020
CriticalFDA
Heartware, Inc.
HeartWare HVAD System Battery Charger The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refra...
Cardiac Devices·5,489 affected·Jan 23, 2020
CriticalFDA
Heartware, Inc.
HeartWare HVAD System Battery Charger AC Adapter The HeartWare HVAD System is indicated for hemodynamic support in patients with advan...
Cardiac Devices·5,489 affected·Jan 23, 2020
High RiskFDA
Compania Nacional De Chocolates Dcr S.a.
Granuts BBQ Mix, Net Wt/Cont. Neto 16.93 oz (480g), Contains 12 units x 1.41 oz (40g) ea. and Net Wt/Cont. Neto 6.35 oz (180g)
Food·6 affected·Jan 22, 2020
RecallFDA
Morton Salt Inc.
MORTON SALT;THIS SALT DOES NOT SUPPLY IODIDE; 26 oz (1LB., 10 OZ) 737 g; packed in 24 canisters per case
Food·4 affected·Jan 22, 2020
RecallFDA
Ascend Laboratories Llc
Minocycline Hydrochloride Extended-Release Tablets, USP, 105 mg*, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mum...
Oral Drugs·4,728 affected·Jan 22, 2020
High RiskFDA
Biofire Diagnostics, Llc
FilmArray BCID Panel, RFIT-ASY-0126, 30, Rx Only, CE, IVD, UDI: 00815381020086 used with the following BACT/ALERT Blood Culture Bottle ...
Diagnostic Devices·18,501 affected·Jan 22, 2020
High RiskFDA
St Jude Medical, Cardiac Rhythm Management Division
Ellipse, Tiered-therapy Cardioverter/Defibrillator, REF (UDI/GTIN): CD1377-36QC (05414734507646), CD2411-36C (05414734507585), CD1277-36 ...
Cardiac Devices·256 affected·Jan 22, 2020
High RiskFDA
Braemar Manufacturing, Llc
Braemar Manufacturing LLC DL950 Holter Monitor 1285 Corporate Center Dr. Suite 150 Eagan, MN 55121 USA Rx Only
Medical Devices·10,582 affected·Jan 22, 2020
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Triton Canister System (finished part numbers FG 12009, for 3L canisters, and FG 12019 for 2L canisters) Scanning Label (component part n...
Medical Devices·16,700 affected·Jan 22, 2020
CriticalFDA
Sysmex America, Inc.
Sysmex CV-11 Sample Unit, an integrated modular sampler that conveys specimens to either the UF-5000 or UD-10 analyzers.
Medical Devices·40 affected·Jan 21, 2020
High RiskFDA
Medline Industries Inc
Medline ROBOTIC-LF REF CDS984543B Lot 20AKA927 Expiration 2020-09-30 GTIN (01)10888277056350
Medical Devices·122 affected·Jan 21, 2020
High RiskFDA
Hologic, Inc.
Selenia Dimensions Mammography System, Model number ASY-04160, Selenia Dimensions Gantry, UDI 15420045505636,
Medical Devices·72 affected·Jan 21, 2020