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High RiskFDA
J & J Distributing Company
Kowalski's Markets, Protein Powerhouse, UPC 6-10014-14692-4, 8 oz in plastic container.
Food·1 affected·Mar 14, 2017
High RiskFDA
J & J Distributing Company
Detox Salad, 8 oz. Plastic deli container with various brand names: Cub Foods (Fresh) UPC 610014-155698 , Cuttin' Time UPC 610014-160876,...
Produce·7 affected·Mar 14, 2017
High RiskFDA
J & J Distributing Company
Shred Carrots, 3 lb Food Service plastic bag.
Food·6 affected·Mar 14, 2017
High RiskFDA
J & J Distributing Company
Kowalski's Markets, Carrot, Apple, Hummus Wrap UPC 6-10014-09915-2 & Vegetable Wrap UPC 6-10014-08723-4 , 11 oz in plastic container.
Produce·11 affected·Mar 14, 2017
High RiskFDA
J & J Distributing Company
Kowalski's Markets, Salad Super Kale, UPC 6-10014-14316-9, 9 oz in plastic container.
Produce·10 affected·Mar 14, 2017
High RiskFDA
J & J Distributing Company
Cub Foods (Fresh), Cranberry Walnut Salad, UPC 0-41144-37302-5, 20 0z. Plastic deli container. Kowalski's Markets, Salad Greens, Cranbe...
Produce·8 affected·Mar 14, 2017
High RiskFDA
J & J Distributing Company
Rainbow Coleslaw, 5 lbs for Food Service (Franchise) in Food service plastic bag.
Food·3 affected·Mar 14, 2017
High RiskFDA
Nexstim Plc
Nexstim eXima NBS System Software version 2.2 or higher. The Nexstim Navigated Brain Stimulation System (NBS System) is indicated for no...
Surgical Devices·11 affected·Mar 14, 2017
High RiskFDA
Hans Pausch Rontgengeratebau Gmbh
Pausch Uroview FD fluoroscopic X-ray system UDI number (01)04260491620040 Primarily for urological applications (functional X-ray diagn...
Diagnostic Devices·10 affected·Mar 14, 2017
High RiskFDA
Nexstim Plc
NBS System 4 (sw version 4.0 or higher), Software update to 4.3.3 and NBS System 5 (sw version 5.0 or higher), Software update to 5.1.1. ...
Surgical Devices·21 affected·Mar 14, 2017
High RiskFDA
Roche Diabetes Care, Inc.
Accu-Chek Connect Diabetes Management App versions 2.0.0, 2.0.1 and 2.1.0 for iOS and Android Product Usage: This is a digital produc...
Diabetes Devices·64,324 affected·Mar 14, 2017
High RiskFDA
Genentech Inc.
Cotellic (cobimetinib) Tablets, 20 mg, 63 count bottle, Rx Only, Made in Switzerland. Distributed by Genentech USA, Inc., South Francisco...
Oral Drugs·748 affected·Mar 13, 2017
High RiskFDA
Akorn Inc
Sulfamethoxazole and Trimethoprim Oral Suspension, USP 200 mg / 40 mg per 5 mL , Grape Flavor, Rx Only, 16 fl oz. (473 mL), HI-TECH PHARM...
Oral Drugs·55,968 affected·Mar 13, 2017
High RiskFDA
Measurement Specialties Inc
Measurement Specialties Reusable Temperature Probe Autoclavable. Sold as Esophageal/Rectal (Adult), Esophageal/Rectal (Pediatric), and S...
Medical Devices·6,076 affected·Mar 13, 2017
High RiskFDA
Instradent Usa, Inc.
NEODENT CM Intraoral Scanbody, Article Number: 108.139
Medical Devices·170 affected·Mar 13, 2017
High RiskFDA
Nihon Kohden America Inc
Bedside monitor CSM-1901(Life Scope G9) with main unit CU-192RA. The Problem only affects CSM-1901(Life Scope G9) communicating with CN...
Medical Devices·654 affected·Mar 13, 2017
High RiskFDA
Valeant Pharmacueticals International
Small Particle Aerosol Generator Model SPAG-2 6000 Series (SPAG-2). The SPAG-2 medical device is a pneumatic flow system indicated for th...
Respiratory Devices·418 affected·Mar 13, 2017
High RiskFDA
Nestle Usa
Haagen-Dazs Chocolate Dark Chocolate Ice Cream Bars; 3 - 3 FL oz.. bars (9 FL ox (266 ml)
Dairy·82 affected·Mar 10, 2017
High RiskFDA
Claris Lifesciences Inc
Fluconazole Injection, USP, 400 mg in 200 mL, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris I...
Injectable Drugs·18,096 affected·Mar 10, 2017
High RiskFDA
Claris Lifesciences Inc
Levofloxacin Injection in 5% Dextrose, 750 mg in 150 mL 5% Dextrose, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick...
Injectable Drugs·24,456 affected·Mar 10, 2017
High RiskFDA
Claris Lifesciences Inc
Ciprofloxacin in Dextrose (5%) Injection, USP, 400 mg in 200 mL 5% Dextrose, Rx only, Manufactured for: Claris Lifesciences Inc. North Br...
Injectable Drugs·18,360 affected·Mar 10, 2017
High RiskFDA
Claris Lifesciences Inc
Metronidazole Injection, USP, 500 mg/100 mL, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris In...
Injectable Drugs·72,072 affected·Mar 10, 2017
High RiskFDA
Beckman Coulter Inc.
Access Ferritin Calibrators, Part No. 33025, Ref No. B50136C
Medical Devices·889 affected·Mar 10, 2017
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Stryker PROFESS Registration Kit. The Stryker PROFESS Registration Kit is a member of the Navigation portfolio and is used as an intraop...
Medical Devices·65 affected·Mar 10, 2017
High RiskFDA
Ge Healthcare, Llc
Vivid S60/S70/S60N/S70N, H45041SU, H45041SW, H45581MS, H45581PD.
Medical Devices·396 affected·Mar 10, 2017
High RiskFDA
Ge Healthcare, Llc
Vivid E95/E90/E80, H45581DC, H45581LB and H45581DA.
Medical Devices·971 affected·Mar 10, 2017
High RiskFDA
Vivaceuticals, Inc. Dba Regeneca Worldwide
RegeneSlim
Food·4,000 affected·Mar 9, 2017
High RiskFDA
Vivaceuticals, Inc. Dba Regeneca Worldwide
RegeneBlend
Food·3,000 affected·Mar 9, 2017
High RiskFDA
Vivaceuticals, Inc. Dba Regeneca Worldwide
RegeneArouse
Food·0 affected·Mar 9, 2017
High RiskFDA
Vivaceuticals, Inc. Dba Regeneca Worldwide
RegeneBlast
Food·0 affected·Mar 9, 2017
High RiskFDA
Vivaceuticals, Inc. Dba Regeneca Worldwide
RegeneFit
Food·300 affected·Mar 9, 2017
High RiskFDA
Vivaceuticals, Inc. Dba Regeneca Worldwide
RegeneBoost
Food·1,800 affected·Mar 9, 2017
High RiskFDA
Vivaceuticals, Inc. Dba Regeneca Worldwide
RegenErect
Food·0 affected·Mar 9, 2017
High RiskFDA
Smith & Nephew, Inc.
D-RAD, S.T. LOCKING SCREWS, T7, QTY: (1), STERILE R, in the following sizes: (a) 2.4MM X 10MM, RES 74692410 (b) 2.4MM X 12MM, RES 74692...
Medical Devices·197 affected·Mar 9, 2017
High RiskFDA
Centurion Medical Products Corporation
CUSTOM CADAVER KIT The Covidien Curity Oval Eye Pads are individually packaged and sterilized by the manufacturer; they are then placed ...
Medical Devices·540 affected·Mar 9, 2017
High RiskFDA
Smith & Nephew, Inc.
Peri-Loc(R) VLP 3.5 MM X 6 MM SELF-TAPPING CORTEX SCREW, QTY: (1), STERILE R, REF 71801306 Orthopedic
Medical Devices·1 affected·Mar 9, 2017
High RiskFDA
Smith & Nephew, Inc.
D-RAD, 1.8MM X 16MM, LOCKING PEG, QTY: (1), STERILE R, RES 74671816 Orthopedic
Medical Devices·19 affected·Mar 9, 2017
High RiskFDA
Smith & Nephew, Inc.
D-RAD, 2.4MMX 20MM, S.T. CORTEX SCREW, QTY: (1), STERILE R, RES 74682420 Orthopedic
Medical Devices·100 affected·Mar 9, 2017
High RiskFDA
Cincinnati Sub-zero Products Inc
Hemotherm CE, model 400CE, Heater-Cooling Device
Medical Devices·390 affected·Mar 9, 2017
High RiskFDA
Centurion Medical Products Corporation
OPHTHALMIC DRESSING TRAY The Covidien Curity Oval Eye Pads are individually packaged and sterilized by the manufacturer; they are then p...
Medical Devices·1,692 affected·Mar 9, 2017
High RiskFDA
Centurion Medical Products Corporation
OPHTHALMIC DRS TRAY The Covidien Curity Oval Eye Pads are individually packaged and sterilized by the manufacturer; they are then plac...
Medical Devices·588 affected·Mar 9, 2017
High RiskFDA
Gerber Products Company Dba Nestle Infant Nutrition
Gerber¿ Pasta Pick-Ups Cheese Ravioli Net Wt 6 oz (170g) Drained Wt 3 oz (85g) UPC 01500000907-6 , Truncated - written on packag...
Dairy·99,032 affected·Mar 8, 2017
High RiskFDA
Mckesson Medical Surgical
hydrALAZINE HYDROCHLORIDE INJECTION, USP, 20 mg/mL, 1 mL Single Dose Vial, packaged in 25 Vials per carton, Rx only, APP Fresenius Kabi U...
Injectable Drugs·98 affected·Mar 8, 2017
High RiskFDA
Isomeric Pharmacy Solution, Llc
Triamcinolone 40 mg/mL 2 mL Single-Dose Vial for Injection, Preservative Free, Rx only, Compounded by Isomeric Pharmacy Solutions, Salt ...
Injectable Drugs·6,999 affected·Mar 8, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Siemens ADVIA Centaur BR assay Cat No. 03896216, SMN 10334837 (5-pack/250 tests) BR Assay for CA 27.29 The ADVIA Centaur¿ BR assay ...
Diagnostic Devices·1,900 affected·Mar 8, 2017
High RiskFDA
Biomet 3i, Llc
BIOMET 3i LTX DENTAL IMPLANTS Model LTX610 (6x10mm) - Plastic tray within Tyvek tray within cardboard box; one (1) unit per box. Labe...
Medical Implants·5 affected·Mar 8, 2017
High RiskFDA
Ferno-washington Inc
Ferno PROFlexx¿ Model 28Z Chair Cot
Medical Devices·34 affected·Mar 8, 2017
High RiskFDA
Sonesta Medical Ab
Sonesta S2; Article numbers: 525-S2-110V and 525¿¿S2-220V
Medical Devices·28 affected·Mar 8, 2017