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High RiskFDA
Medtronic Navigation, Inc.
SPHERES 8801071 1/TRAY 12PK
Medical Devices·26,674 affected·Apr 24, 2014
High RiskFDA
Davol, Inc., Subs. C. R. Bard, Inc.
Bard¿ Composix" LIP Mesh with Echo PS" 7"x9" Reorder Number: 0144790 Indicated for use in the reconstruction of soft tissue deficienc...
Medical Devices·0 affected·Apr 24, 2014
High RiskFDA
Davol, Inc., Subs. C. R. Bard, Inc.
Composix" LP with Echo PS" 10x13 HUXH0294 HUXL0314 Indicated for use in the reconstruction of soft tissue deficiencies, such as the r...
Medical Devices·0 affected·Apr 24, 2014
High RiskFDA
Medtronic Navigation, Inc.
TRAJ GUIDE KIT, 9733065, BIOPSY, EXT
Medical Devices·26,674 affected·Apr 24, 2014
High RiskFDA
Medtronic Navigation, Inc.
BIT 9733516 2.9mm DRILL STERILE
Medical Devices·26,674 affected·Apr 24, 2014
High RiskFDA
Baxter Healthcare Corp.
Baxter Amia Automated PD systems are used in the treatment of adult renal failure patients to perform automated peritoneal dialysis.
Medical Devices·55 affected·Apr 24, 2014
High RiskFDA
Medtronic Navigation, Inc.
SPHERES 8801075 5/TRAY 12PK
Medical Devices·26,674 affected·Apr 24, 2014
High RiskFDA
Davol, Inc., Subs. C. R. Bard, Inc.
Bard¿Ventralight" ST Mesh with Echo PS" 10"x13" Reorder Number: 5955113 Indicated for use in the reconstruction of soft tissue defici...
Medical Devices·0 affected·Apr 24, 2014
High RiskFDA
Davol, Inc., Subs. C. R. Bard, Inc.
Composix" LP with Echo PS" 6x8 Reorder Number: 0144680 Indicated for use in the reconstruction of soft tissue deficiencies, such as...
Medical Devices·0 affected·Apr 24, 2014
High RiskFDA
Medtronic Navigation, Inc.
TUMOR RESECTION KIT 9733607 NON-INVASIVE
Medical Devices·26,674 affected·Apr 24, 2014
High RiskFDA
Medtronic Navigation, Inc.
SHUNT KIT 9733605 NON-INVASIVE
Medical Devices·26,674 affected·Apr 24, 2014
High RiskFDA
Medtronic Navigation, Inc.
INSTRUMENT TRACKER 9733533XOM ENT 1PK
Medical Devices·26,674 affected·Apr 24, 2014
High RiskFDA
Medtronic Navigation, Inc.
DISP 9730950 STRL SPHERE, 1 PK INSERT
Medical Devices·26,674 affected·Apr 24, 2014
High RiskFDA
Aqua Filter Fresh, Inc.
On cap Purified Water Bottled at Aqua Filter Fresh, Inc., Pittsburgh, PA 15239 Permit #504 Source: Plum Boro Municipal Authority 1523...
Beverages·2,436 affected·Apr 23, 2014
High RiskFDA
Kodiak Wild Alaska Seafood
Pacific Cod, skinless boneless fillet; vacuum packaged in a clear plastic bag. The wt of the fish is the only labeling included on this ...
Seafood·25 affected·Apr 23, 2014
High RiskFDA
Teva Pharmaceuticals Usa
QVAR¿ (beclomethasone dipropionate HFA), 80mcg Inhalation Aerosol, 50 metered inhalations/120 metered inhalations, packaged in an aluminu...
Drugs·461,592 affected·Apr 23, 2014
High RiskFDA
C P Medical Inc.
Monoswift¿ PGCL [poly (glycolide-co-caprolactone)] Absorbable Surgical Suture; USP size 3/0 PGCL; part number L936. Product is labeled...
Surgical Devices·4 affected·Apr 23, 2014
High RiskFDA
William C. Domb, D.m.d., A Professional Corporation
Enaly 1000 BT-12 Ozone Generator, Model # 1000BT-12 The 1000BT-12 ozone generator is capable of delivering up to 1gram of ozone per ho...
Respiratory Devices·16 affected·Apr 23, 2014
High RiskFDA
Siemens Medical Solutions Usa, Inc.
e.cam camera system. Emission Computed Tomography System used to detect or image the distribution of radionuclides in the body or organ,...
Diagnostic Devices·2,458 affected·Apr 23, 2014
High RiskFDA
Ge Healthcare, Llc
GE Healthcare Discovery MR450, Discovery MR750, Optima MR450w, Optima MR450w equipped with the GEM option, Discovery MR750w, and Discover...
Diagnostic Devices·1,548 affected·Apr 23, 2014
High RiskFDA
Elekta, Inc.
Synergy XVI Intended for radiation therapy treatment.
Medical Devices·380 affected·Apr 23, 2014
High RiskFDA
Sigmapharm Laboratories Llc
Liothyronine Sodium Tablets, USP 5 mcg, Rx Only, a) 100-count bottle NDC 42794-018-02 and b) 1000-count bottle NDC 42794-018-06, SigmaPha...
Oral Drugs·43,007 affected·Apr 22, 2014
High RiskFDA
Smiths Medical Asd, Inc.
SW-2008 Snuggle Warm Sterile Cardiac Connective Warming Blanket; used with the Equator Convective Warmer, are intended for thermal regul...
Cardiac Devices·2,120 affected·Apr 22, 2014
High RiskFDA
Beckman Coulter Inc.
UniCel DxC Synchron Clinical Systems and UniCel DxC Synchron Access Integrated Clinical Systems The affected part is Part number 70300...
Medical Devices·3,540 affected·Apr 22, 2014
High RiskFDA
Meridian Bioscience Inc
illumipro-10 Incubator/Reader, Meridian Bioscience, Inc. The illumipro-10 incubator/reader is designed to be used with illumigene Mole...
Diagnostic Devices·35 affected·Apr 22, 2014
High RiskFDA
Wegmans Food Markets, Inc.
Scale label printed with "EASTER BREAD NET WT 17oz (1.06lb)" UPC 0 77890 32431 8, packaged in clear plastic bag
Bakery & Grains·29,681 affected·Apr 21, 2014
High RiskFDA
Pharmakon Pharmaceuticals
Glycopyrrolate 0.2 mg/ml, 5 mL pre-filled syringe, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville, IN 46060, NDC...
Drugs·200 affected·Apr 21, 2014
High RiskFDA
Baxter Healthcare Corp.
0.9% Sodium Chloride Irrigation, USP, 1000 mL,Not for Injection, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015, USA...
Injectable Drugs·211,752 affected·Apr 21, 2014
High RiskFDA
Aesculap, Inc.
Aesculap Inc.(AIC) Miethke Ventricular Catheter with Deflector/Miethke Shunt System The Miethke Shunt System is intended to shut cere...
Surgical Devices·48 affected·Apr 21, 2014
High RiskFDA
Med-mizer, Inc.
RetractaBed , Clinical Contour, Med - Mizer Inc..... Model SS 762 ( 76 " bed w/ 2 motors); 763 (3 motors); 763 A ( 3 motors, autocontou...
Medical Devices·191 affected·Apr 18, 2014
High RiskFDA
Nellcor Puritan Bennett Inc. (dba Covidien Lp)
Recalled product is a component of the Newport Medical Instruments e360 Ventilator: single board computer, part number SBC2105A. Inte...
Respiratory Devices·5,765 affected·Apr 18, 2014
High RiskFDA
Leica Microsystems, Inc.
Thyroglobulin (1D4) is a mouse anti-human monoclonal antibody produced as a tissue culture supernatant, and supplied in Tris buffered sal...
Diagnostic Devices·180 affected·Apr 18, 2014
High RiskFDA
Wockhardt Usa Inc.
Wockhardt Metoprolol Succinate, Extended-Release Tablets USP, 50 mg, a)100-count HDPE bottle (NDC 64679-735-02), b) 4000-count pack (64...
Oral Drugs·1,118,400 affected·Apr 17, 2014
High RiskFDA
Teleflex Medical
Hudson RCI Adult Universal Ventilator Circuit, Duel Heated Limb and Hudson RCI Adult Heated Wire Circuit Kit with Column
Respiratory Devices·2,600 affected·Apr 17, 2014
High RiskFDA
Ortho-clinical Diagnostics
enGen (TM) Laboratory Automation System Configured with TCAutomation" Software v3.5 -- For in vitro quantitative measurement of a variety...
Diagnostic Devices·6 affected·Apr 17, 2014
High RiskFDA
Nanosphere, Inc.
Verigene Gram-Negative Blood Culture Nucleic Acid Test (BC-GN), performed using the sample-to-result Verigene System, is a qualitative mu...
Diagnostic Devices·580 affected·Apr 17, 2014
High RiskFDA
Oaxaca Mexican Products
Botanos Los 3 Chavos Mango Enchilado Net Wt. 1 1/2 OZ. (42 g) Oaxaca Mexican Products 100 8th Street, Passaic, NJ 07055
Food·10 affected·Apr 16, 2014
High RiskFDA
Pfizer Us Pharmaceutical Group
Pristiq (desvenlafaxine) Extended-Release Tablets 50 mg, 30 count bottle, Rx only, Distributed by Wyeth Pharmaceuticals, Inc., NDC 0008-...
Oral Drugs·220,761 affected·Apr 16, 2014
High RiskFDA
Heartware Inc
HeartWare HVAD Pump Implant Kit (Heartware Ventricular Assist Device) - HeartWare Battery For use as a bridge-to-cardiac transplantati...
Medical Implants·32,349 affected·Apr 16, 2014
High RiskFDA
Stryker Endoscopy
12-Instrument Sterilization Tray; Product Usage: The 12-Instrument Tray is used to hold and protect surgical instruments during the s...
Surgical Devices·2,591 affected·Apr 16, 2014
High RiskFDA
Integra Lifesciences Corp.
Integra Licox Test Kit REF BC10R Rx Only An accessory provided for use with the LCXO2 and AC31 PtO2 Monitors. It provides users with ...
Diagnostic Devices·49 affected·Apr 16, 2014
High RiskFDA
Gambro Renal Products, Incorporated
Polyflux Revaclear Max, Capillary Dialyzer, Model Number 110634; Gambro Renal Products, Inc. Intended for the treatment of acute and...
Medical Devices·2,461,824 affected·Apr 16, 2014
High RiskFDA
P&l Developments, Llc
Children's Triacting Night Time Cold & Cough with PE (diphenhydramine hcl and phenylephrine hcl), Grape Flavor, For Ages 6 to 11, 4 fl o...
Drugs·1,363,338 affected·Apr 15, 2014
High RiskFDA
Biomet, Inc.
EZPass Nylon Monofilament Single Pack, Part number 110007379, Orthopedic Manual Surgical Instrument Sterile, single use arthroscopic inst...
Surgical Devices·100 affected·Apr 15, 2014
High RiskFDA
Handicare Usa, Inc.
ReTurn 7500/7500 Aid, transfer
Medical Devices·29 affected·Apr 15, 2014
High RiskFDA
Cordis Corporation
RenLane Renal Denervation Catheter; Cat No.: D135601. Used in adults patients (>18 years) with drug resistant hypertension to denervate ...
Surgical Devices·98 affected·Apr 15, 2014
High RiskFDA
Biomet, Inc.
EZPass Passer, Sterile single use arthroscopic instrument utilized in conjunction with a nitinol wire to aid in passing suture through so...
Medical Devices·102 affected·Apr 15, 2014
High RiskFDA
Orange Peel Enterprises, Inc.
Greens+ Vegan Crisp Bars - Dark Chocolate Almond Coffee Crisp in 1.4 oz packages.
Snacks & Candy·117,036 affected·Apr 14, 2014