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High RiskFDA
Integra Lifesciences Corp.
Talar Dome Total Ankle Prosthesis , Sloped, Size 3, Left, Product No. LJV193T
Medical Implants·2,029 affected·Mar 8, 2019
High RiskFDA
Integra Lifesciences Corp.
Talar Dome Total Ankle Prosthesis , Sloped, Size 0, Right, Product No. LJV180T
Medical Implants·2,029 affected·Mar 8, 2019
High RiskFDA
Good Karma Foods Inc
PL Trader Joe Natural Creamer - Vanilla 12/32oz, Plastic bottle, Distributed by Good Karma Foods, Inc. with manufacturing at Shamrock Foo...
Food·37,001 affected·Mar 7, 2019
High RiskFDA
Rising Pharmaceuticals, Inc.
Valsartan Tablets 40 mg USP, 30 tablet bottles, Rx, Only, Distributed by: Acetris Health, LLC, Saddle Brook, NJ, Manufactured by: Auroli...
Oral Drugs·30,530 affected·Mar 7, 2019
RecallFDA
Boehringer Ingelheim Pharmaceuticals, Inc.
Mirapex (pramipexole dihydrochloride) Tablets, 1 mg, 100-count unit-dose tablets per folding carton, Rx only, Distributed by: Boehringer ...
Oral Drugs·112 affected·Mar 7, 2019
High RiskFDA
Rising Pharmaceuticals, Inc.
Valsartan Tablets 320 mg USP, 90 tablet bottles, Distributed by: Acetris Health, LLC, Saddle Brook, NJ 07663, Manufactured by: Aurolife P...
Oral Drugs·42,016 affected·Mar 7, 2019
High RiskFDA
Medtech Products, Inc.
Little Remedies New Baby Essentials Kit. Each kit contains 1 each of the following products: Little Remedies Infant Fever Reducer (acetam...
Topical Drugs·4,716 affected·Mar 7, 2019
High RiskFDA
Rising Pharmaceuticals, Inc.
Valsartan Tablets 80 mg USP, 90 tablet bottles, Rx only, Distributed by: Acetris Health, LLC, Saddle Brook, NJ 07663, Manufactured by: A...
Oral Drugs·37,410 affected·Mar 7, 2019
High RiskFDA
Rising Pharmaceuticals, Inc.
Valsartan Tablets 160 mg USP, 90 tablet bottles, Rx only, Distributed by: Acetris Health, LLC, Saddle Brook, NJ 07663, Manufactured by: A...
Oral Drugs·35,281 affected·Mar 7, 2019
High RiskFDA
Biofire Diagnostics, Llc
FilmArray BCID Panel, IVD, Rx Only, BioFire Diagnostics, REF: RFIT-ASY-0126, and RFIT-ASY-0127, when used with the following blood cult...
Diagnostic Devices·20,350 affected·Mar 7, 2019
High RiskFDA
Stryker Corporation
Stryker High Flow II Tube Set, REF 0620-040-660, an accessory to the PNEUMO SURE High Flow Insufflator, Disposable, Rx, Sterile.
Medical Devices·32,537 affected·Mar 7, 2019
High RiskFDA
Stryker Corporation
Stryker High Flow Tube Set with Real-Time Pressure Sensing (RTP), REF 0620-040-680, an accessory to the PNEUMO SURE High Flow Insufflator...
Medical Devices·5,089 affected·Mar 7, 2019
High RiskFDA
Abbott Gmbh & Co. Kg
Abbott Alinity ci-series System Control Module software version 2.5.1; LN 3R70-01 with the following hardware: Level Sensor, Bulk Solutio...
Diagnostic Devices·1,557 affected·Mar 7, 2019
High RiskFDA
Becton Dickinson & Company
BD Vacutainer Eclipse Blood Collection Needles 22Gx1.25, cat. no. 368608
Medical Devices·2,624,160 affected·Mar 7, 2019
High RiskFDA
Becton Dickinson & Company
BD Blood Collection Assembly with Male Luer Lock, Catalog Number MBC6010
Medical Devices·6,509,600 affected·Mar 7, 2019
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica IM 1600 Analyzer, Material Number 11066000
Medical Devices·366 affected·Mar 7, 2019
High RiskFDA
American Health Packaging
Valsartan Tablets USP 160 mg, 100 Tablets (10 x 10) per Unit Dose Blisters, Rx Only, Packaged and Distributed by: American Health Packa...
Oral Drugs·3,337 affected·Mar 6, 2019
High RiskFDA
Dr. Reddy's Laboratories, Inc.
Docetaxel Injection USP, 80 mg/4 mL, (20 mg/mL), One-Vial Formulation, Rx only, Mfd By: Dr. Reddy's Laboratories Limited, Visakhapatnam -...
Injectable Drugs·5,755 affected·Mar 6, 2019
High RiskFDA
Preferred Pharmaceuticals, Inc
Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottle (NDC: 68788-0048-03), b) 90-count bottle (NDC: 68788-0048-09), Rx Only, Mfg: T...
Oral Drugs·530 affected·Mar 6, 2019
High RiskFDA
Biofire Diagnostics, Llc
FilmArray Gastrointestinal (GI) Panel, IVD, Rx Only, Biofire Diagnostics, LLC REF: RFIT-ASY-0104, and RFIT-ASY-0116), Product Usage...
Diagnostic Devices·17,188 affected·Mar 6, 2019
High RiskFDA
Acclarent, Inc.
TruDi NAV Suction, TDNS070Z, 70 Degree Tip Angle (01) 10705031245884
Medical Devices·0 affected·Mar 6, 2019
High RiskFDA
Acclarent, Inc.
TruDi NAV Suction, TDNS090Z, 90 Degree Tip Angle, (01) 10705031245891
Medical Devices·0 affected·Mar 6, 2019
High RiskFDA
Topcon Medical Systems, Inc.
IMAGEnet 6 v1.53- IMAGEnet 6 Ophthalmic Data System is a software program that is intended for use in the collection, storage and manag...
Diagnostic Devices·450 affected·Mar 6, 2019
High RiskFDA
Procept Biorobotics Corporation
AquaBeam Handpiece, Sterile EO, Rx Only, REF: 310301, and 320301, a component of AquaBeam Robotic System. 320301 distributed outside the...
Medical Devices·214 affected·Mar 6, 2019
CriticalFDA
Usa Less Inc.
LEOPARD Miracle Honey packaged in a wooden box, UPC 8 699415 910534, containing 12 sachets 180Gr / 6.36 Oz, each 1 Sachet 15 gr / 0.53 Oz...
Drugs·83 affected·Mar 5, 2019
High RiskFDA
Avkare Inc.
Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only Manufactured for: AvKAR...
Oral Drugs·0 affected·Mar 5, 2019
High RiskFDA
Avkare Inc.
Losartan Potassium Tablets USP 50 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only, Manufactured for: AvKARE Inc. Pulaski, TN 38478 ---- NDC...
Oral Drugs·0 affected·Mar 5, 2019
High RiskFDA
Avkare Inc.
Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only Manufactured for: AvKARE...
Oral Drugs·0 affected·Mar 5, 2019
High RiskFDA
Becton Dickinson & Company
Gravity IV Set with 3-port Closed Stopcock Manifold Model CM42500E-07
Medical Devices·21,220 affected·Mar 5, 2019
CriticalFDA
Procesadora Aguas Claras Ltda.
Premium Sustainable Atlantic Salmon (Farm Raised); 22 lb. case - Master carton - corrugated cardboard box. Internal Packaging: IQF vacuu...
Seafood·157 affected·Mar 4, 2019
RecallFDA
Petra Hygienic Systems Int Ltd
ATHLETICARE Anti-Bacterial Hand Soap AC 550 (triclosan), 0.25%, 4 litres/1.1 US Gallon bottles, packaged in 4 x 4 Litres/1.1 US gallons p...
Drugs·58 affected·Mar 4, 2019
High RiskFDA
H J Harkins Company Inc Dba Pharma Pac
Losartan Potassium 100 mg Tablets # 30 Losartan potassium tablets USP, 100 mg are white to off white, film coated, tear drop shaped tabl...
Oral Drugs·300 affected·Mar 4, 2019
RecallFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Medtronic Pulmonary Vein Ablation Catheter(R) GOLD (PVAC GOLD) 990078 - Product Usage: The Pulmonary Vein Ablation Catheter GOLD is desig...
Cardiac Devices·2,917 affected·Mar 4, 2019
High RiskFDA
Viewray, Inc.
MRIdian Linac Radiation Therapy System Model 10000 and 20000
Medical Devices·24 affected·Mar 3, 2019
High RiskFDA
Surtidoras Bakery Inc
Vanilla Muffin, brand Surtidoras Bakery, net wt. 1.74 lbs., packaged in rigid plastic clam shell container. No UPC. The allergens decl...
Dairy·40 affected·Mar 2, 2019
High RiskFDA
Surtidoras Bakery Inc
Kid's Rainbow Cookies, brand Surtidoras Bakery, net wt.15.52 oz., packaged in rigid plastic clam shell container. No UPC. The allerge...
Dairy·50 affected·Mar 2, 2019
High RiskFDA
Surtidoras Bakery Inc
Mini-Puff Pastry Ears, brand Surtidoras Bakery, net wt. 10.4 oz., packaged in rigid plastic clam shell container. No UPC. The allergen...
Bakery & Grains·35 affected·Mar 2, 2019
High RiskFDA
Surtidoras Bakery Inc
Kid's Chocolate Cookies, brand Surtidoras Bakery, net wt.15.52 oz., packaged in rigid plastic clam shell container. No UPC. The aller...
Dairy·20 affected·Mar 2, 2019
CriticalFDA
Surtidoras Bakery Inc
Blueberry Muffin, brand Surtidoras Bakery, net wt. 1.74 lbs., packaged in rigid plastic clam shell container. No UPC. The allergens de...
Produce·44 affected·Mar 2, 2019
CriticalFDA
Surtidoras Bakery Inc
Banana Muffin, brand Surtidoras Bakery, net wt. 1.74 lbs., packaged in rigid plastic clam shell container. No UPC. The allergens decla...
Food·104 affected·Mar 2, 2019
High RiskFDA
Surtidoras Bakery Inc
Pecan Cookies, brand Surtidoras Bakery, net wt. 1.08 lbs., packaged in rigid plastic clam shell container. No UPC. The allergens decla...
Dairy·30 affected·Mar 2, 2019
CriticalFDA
Surtidoras Bakery Inc
Marble Muffin, brand Surtidoras Bakery, net wt. 1.74 lbs., packaged in rigid plastic clam shell container. No UPC. The allergens decla...
Food·21 affected·Mar 2, 2019
CriticalFDA
Elite Spice Inc.
Basil Olive Oil Flavored Tortilla Seasoning Package Type: Box with liner, Units Per Case: 1, Weight Per Package: 50 pounds
Food·10 affected·Mar 1, 2019
High RiskFDA
Cesar Iglesias, S.a.
El Rey Chocolitas 12.69oz (360gr) and 2.2lb (1 Kg)
Food·4,880 affected·Mar 1, 2019
High RiskFDA
Snow's Acquisition, Llc
Snow's PREMIUM ICE CREAM Mint Chip Mint Ice Cream with Dark Chocolate Chunks 1.5 QUART (1.42L) KEEP FROZEN, UPCE: 0 48896400139
Dairy·104 affected·Mar 1, 2019
High RiskFDA
Golden Gate Soy Products, Inc.
Garden Gate Tofu, Firm; Ingredients: Soybean, Filter water, Calcium Sulfate. Contains: soy Sold in 60 piece (bulk box) and 18 pie...
Beverages·1,475 affected·Mar 1, 2019
CriticalFDA
Confections By Michael Recchiuti
Recchiuti Key Lime Apples; Net Wt: 4 oz. Crispy slices of Granny-Smith Apples in Semi-sweet chocolate. Ingredient: Dark chocolate (coco...
Dairy·200 affected·Mar 1, 2019
High RiskFDA
Lamb Weston Inc
Lamb's Supreme Starz, item S0026, is formed star-shaped potato product that has been par-fried and frozen. Product is packaged in a five...
Frozen Food·240 affected·Mar 1, 2019