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High RiskFDA
Baxter Healthcare Corporation
SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE, 3570009
Medical Devices·354 affected·Sep 18, 2018
CriticalFDA
Covidien Llc
Puritan Bennett 980 (PB980) ventilator series: Puritan Bennett" 980 Pediatric Adult Ventilator Puritan Bennett" 980 Neonatal Ventilat...
Respiratory Devices·9,593 affected·Sep 18, 2018
CriticalFDA
Endo Pharmaceuticals, Inc.
robaxin-750 (methocarbamol tablets, USP), 750 mg, 100-count bottle, Rx Only, Distributed by: Endo Pharmaceuticals Inc., Malvern, PA 1935...
Oral Drugs·2,856 affected·Sep 17, 2018
RecallFDA
Otsuka Pharmaceutical Development & Commercialization, Inc.
treatNOW ABILIFY (aripiprazole) / ABILIFY MAINTENA 400-mg (aripiprazole) for extended release injectable suspension. Kit contents 2 packs...
Injectable Drugs·4,738 affected·Sep 17, 2018
High RiskFDA
Medline Industries Inc
SparkleFresh Fluoride Toothpaste, Sodium Monofluorophosphate 0.76%, a) 17 g tube (NDC 53329-083-92, product number NONTP6I), b) 24 g tube...
Drugs·994,756 affected·Sep 17, 2018
RecallFDA
Otsuka Pharmaceutical Development & Commercialization, Inc.
treatNOW ABILIFY (aripiprazole) and ABILIFY MAINTENA (aripiprazole) 400MG for extended release injectable suspension. Kit Contents: 2 pac...
Injectable Drugs·17,325 affected·Sep 17, 2018
High RiskFDA
Sterilmed, Inc.
Reprocessed Agilis Steerable Introducer: indicated for introducing various cardiovascular catheters into the heart. (a) small curl (1...
Cardiac Devices·218 affected·Sep 17, 2018
High RiskFDA
Beckman Coulter Inc.
Kaluza C Flow Cytometry Software, RX Only in the U.S.A., Beckman Coulter, Inc. for the following software devices: (A) Kaluza C Perpe...
Medical Devices·41 affected·Sep 17, 2018
High RiskFDA
Medtronic Navigation, Inc.-littleton
Medtronic Navigation 0-arm 02 Imaging System interventional fluoroscopic x-ray system: OARM BI70002000 SYS IMAGING 02 Model: BI700020...
Medical Devices·641 affected·Sep 17, 2018
CriticalFDA
Leica Microsystems, Inc.
BOND Slide Labeler Zebra Printer Model TLP3842 and Model GX4301, for use with BOND-III and BOND-MAX instruments
Medical Devices·876 affected·Sep 17, 2018
High RiskFDA
Biomerieux Sa
NucliSENS¿ Magnetic Extraction Reagents
Diagnostic Devices·42 affected·Sep 17, 2018
CriticalFDA
Ge Healthcare, Llc
GE Healthcare Millennium MC
Medical Devices·18 affected·Sep 14, 2018
CriticalFDA
Ge Healthcare, Llc
GE Healthcare Millennium MG Multi-Geometry Digital CSE Dual Detector Gamma Camera H3000ZL Acquisition System
Medical Devices·1,166 affected·Sep 14, 2018
High RiskFDA
Livanova Usa Inc.
SORIN Heater-Cooler System 3T, REF 16-02-85 Intended for use with a Stockert/Sorin S3/S5/C5 heart-lung machine and/or any other heart-...
Cardiac Devices·6 affected·Sep 14, 2018
High RiskFDA
Luminex Corporation
VERIGENE Blood Culture Gram-Positive Nucleic Acid Kits (packaged as five-pack carriers) Product Usage: In vitro diagnostic test for...
Diagnostic Devices·12,700 affected·Sep 14, 2018
CriticalFDA
Ge Healthcare, Llc
GE Healthcare Millennium MyoSIGHT Nuclear Cardiology Imaging System H3000ZH Acquisition System
Medical Devices·276 affected·Sep 14, 2018
CriticalFDA
Ge Healthcare, Llc
GE LOGIQ E10 Ultrasound System, Model #530000E10. The device is intended for use by a qualified physician for ultrasound evaluation of...
Cardiac Devices·103 affected·Sep 14, 2018
High RiskFDA
Ecolab Inc
Instrument Arm Drape (Box of 20) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Surgical D...
Surgical Devices·344 affected·Sep 14, 2018
High RiskFDA
Ecolab Inc
Camera Arm Drape (Box of 20) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Surgical Da Vi...
Surgical Devices·88 affected·Sep 14, 2018
High RiskFDA
Brett Anthony Foods
Gotham Greens Classic Pesto 6.5 oz. plastic cup, 12 cups per case. Refrigerated. UPC 85392700334
Food·88 affected·Sep 13, 2018
High RiskFDA
Swanson Health Products, Inc
Swanson Ultra, Himalayan Crystal Salt, #SWU403, Net Wt. 35.27 oz. (2.2 lbs) (1,000 grams). Product of Pakistan. Distributed by Swanson ...
Food·953 affected·Sep 13, 2018
High RiskFDA
Ardent Mills, Llc
Safeguard Soft Flr (GIV) packaged in 50 lb bags
Food·7,500 affected·Sep 13, 2018
High RiskFDA
Lidl Us Trading
Bellona brand Milk Chocolate Flavored Coated Wafer with Hazelnut Cr¿me Filling and White Chocolate Flavor, 5.3 oz. (150g) package contai...
Dairy·52,000 affected·Sep 13, 2018
CriticalFDA
Roche Diagnostics Corporation
CoaguChek¿ XS System Prothrombin time test: CoaguChek XS PT Test 2X24 Strips, Catalog Number: 04625315160; CoaguChek XS PT Test 6 Strip...
Medical Devices·1,163,952 affected·Sep 13, 2018
High RiskFDA
Terumo Cardiovascular Systems Corporation
Terumo¿ Advanced Perfusion System 1 Electronic Patient Gas System, Catalog#: 801188
Medical Devices·152 affected·Sep 13, 2018
High RiskFDA
Arthrex, Inc.
3.2mm Proximal Reamer/Cannulated Drill provided as part of the Fibulock Fibular Nail System Pack. FibuLock Nail Procedure Pack: Contains...
Medical Implants·832 affected·Sep 13, 2018
RecallFDA
Pin Hsiao & Associates, Llc Dba Zen Bakery
TRADER JOE'S Cinnamon Coffee Cake; NET WT. 16 OZ (1 LB) 454g; SKU# 94235; UPC: 00942355
Bakery & Grains·0 affected·Sep 12, 2018
High RiskFDA
Coca Cola Bottling Compan
Sprite 12 FL OZ (355 mL) CONTAINS PHENYLALANINE CAFFEINE FREE THE COCA-COLA COMPANY FOR CONSUMER INFORMATION CALL 1-800-438-2653 UPC 0 49...
Food·309 affected·Sep 12, 2018
RecallFDA
Swire Coca Cola Usa
Caffeine-Free Barq s Root Beer 12 Pack, 12 oz cans
Food·2,945 affected·Sep 12, 2018
High RiskFDA
Sarap Asian Fusion
Ube Cookies & Cream (cookies); A Sarap Asian Fusion Product; NET WT. 65 G/Cookie; Contains: Flour, eggs, Baking Soda, Baking Powder,...
Dairy·0 affected·Sep 12, 2018
High RiskFDA
Sarap Asian Fusion
Black Sesame White Chocolate (cookies); A Sarap Asian Fusion Product; Net WT. 65 G/Cookie; Contains: Flour, eggs, Baking Soda, Bakin...
Dairy·0 affected·Sep 12, 2018
High RiskFDA
Coca Cola Bottling Compan
NO SUGAR NO CALORIES Diet Coke 12 FL OZ (355 mL) CONTAINS PHENYLALANINE CAFFEINE FREE THE COCA-COLA COMPANY FOR CONSUMER INFORMATION CALL...
Food·794 affected·Sep 12, 2018
High RiskFDA
Sarap Asian Fusion
Matcha Chocolate (cookies); A Sarap Asian Fusion Product; NET WT. 70 G/Cookie; Contains: Flour, eggs, Baking Soda, Baking Powder, Mi...
Dairy·0 affected·Sep 12, 2018
High RiskFDA
Coca Cola Bottling Compan
CAFFEINE FREE Diet Coke 12 FL OZ (355 ml) CONTAINS PHENYLALANINE CAFFEINE FREE THE COCA-COLA COMPANY FOR CONSUMER INFORMATION CALL 1-800-...
Food·24 affected·Sep 12, 2018
RecallFDA
Dr. Reddy's Laboratories, Inc.
Zoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL) One 100ml Single-Dose Bottle, Rx Only. NOVAPLUS Mfd By: Gland Pharma Limited D.P. Pal...
Injectable Drugs·10,530 affected·Sep 12, 2018
RecallFDA
Dr. Reddy's Laboratories, Inc.
Zoledronic Acid Injection, 5mg/100 mL (0.05 mg/mL) 100ml vial, Rx Only. Mfd By: Gland Pharma Limited D.P. Pally - 500 043 India: Mfd. For...
Injectable Drugs·59,468 affected·Sep 12, 2018
RecallFDA
Hetero Labs, Ltd. - Unit Iii
Fenofibrate Tablets, USP 145 mg, 90-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ, 08854, NDC 317...
Oral Drugs·5,424 affected·Sep 12, 2018
High RiskFDA
Synthes (usa) Products Llc
3.0mm Headless Compression Screw, Long Thread 18mm, Part Number 04.226.118 DePuy Synthes 3.0mm Headless Compression Screws are intend...
Medical Devices·20 affected·Sep 12, 2018
High RiskFDA
Cmp Industries, Llc
IMPAK Elastic Acrylic Resin Liquid Heat Cure Type 1, Class I, 1 Quart (946ml) REF:3306. Product Usage - Impak Elastic Acrylic Resin Li...
Medical Devices·400 affected·Sep 12, 2018
High RiskFDA
Baxter Healthcare Corporation
EXACTAMIX Empty EVA Bags - 250 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a ...
Medical Devices·158,163 affected·Sep 12, 2018
High RiskFDA
Baxter Healthcare Corporation
EXACTAMIX Empty EVA Bags - 3000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a...
Medical Devices·281,350 affected·Sep 12, 2018
High RiskFDA
Baxter Healthcare Corporation
EXACTAMIX Empty EVA Bags - 1000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a...
Medical Devices·136,800 affected·Sep 12, 2018
High RiskFDA
Baxter Healthcare Corporation
EXACTAMIX Empty EVA Bags - 2000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a...
Medical Devices·456,071 affected·Sep 12, 2018
High RiskFDA
Cmp Industries, Llc
Technoflux IMPAK Resina lfquida acrilica elastic Curado-Calor Tipo 1, Clase 1 REF: 3748GB. Product Usage - Impak Elastic Acrylic Resin...
Medical Devices·40 affected·Sep 12, 2018
High RiskFDA
Howmedica Osteonics Corp.
Tritanium TL Steerable Inserter, Cat. No. 48930000, UDI 07613327381900 Product Usage: The TL Steerable Inserter is a Class 1 instrume...
Medical Devices·58 affected·Sep 12, 2018
High RiskFDA
Baxter Healthcare Corporation
EXACTAMIX Empty EVA Bags - 500 mL - Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to ...
Medical Devices·110,134 affected·Sep 12, 2018
High RiskFDA
Wisconsin Cheese Group, Llc
Sabor Brasil Queijo Minas Frescal Cheese Net Wt. 17.6 oz (498g) UPC 19753-00049 Keep Refrigerated.
Dairy·40 affected·Sep 11, 2018
High RiskFDA
Wisconsin Cheese Group, Llc
Lupita Panela Fresca, Mexican Style Farmer's Cheese. Net Wt. 17.6 oz (498g) UPC 19753-00608 Keep Refrigerated.
Dairy·25 affected·Sep 11, 2018