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High RiskFDA
Tyrx Inc.
TRYX Antibacterial Envelope Rx Only Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardi...
Medical Implants·3,460 affected·Jun 29, 2016
High RiskFDA
Carefusion 2200 Inc
Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM, PINK/RED Oxygen Delivery Module 2/PACK, Product Code 7700RAW2
Respiratory Devices·544 affected·Jun 29, 2016
High RiskFDA
Trividia Health
TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult and TRUE2go meters. TRUEread Blood Glucose Test Strips are ...
Diabetes Devices·5,527,921 affected·Jun 28, 2016
High RiskFDA
Trividia Health
TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult and TRUE2go meters. TRUEread Blood Glucose Test Strips are ...
Diabetes Devices·5,527,921 affected·Jun 28, 2016
High RiskFDA
Trividia Health
TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult and TRUE2go meters. TRUEread Blood Glucose Test Strips are ...
Diabetes Devices·5,527,921 affected·Jun 28, 2016
High RiskFDA
Chg Hospital Beds Inc
Spirit Plus Bed, A-C Powered Hospital Bed
Medical Devices·4,308 affected·Jun 28, 2016
High RiskFDA
Medtronic Xomed, Inc.
NIM EMG Endotracheal Tube, 6.0 mm I.D. x 8.8 mm O.D. (27 FR), Reinforced, Sterile, Rx only. Individually packaged.
Medical Devices·3,752 affected·Jun 28, 2016
High RiskFDA
Synthes (usa) Products Llc
Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Synthes 2.4mm Titanium Locking Screws Self-Tapping with St...
Medical Devices·41 affected·Jun 28, 2016
High RiskFDA
Conmed Corporation
CORE¿ Suction Irrigation Handpiece with 5mm x 32cm Length Probe for Single Solution or Dual Bags, Catalog Number CD8190 The CORE Trumpe...
Medical Devices·0 affected·Jun 27, 2016
High RiskFDA
Zimmer Gmbh
V-TEK TWIST D 3.5X90MM 30MM Can 12MM Rnd; The twist drill is used to drill holes into bones/tissues for foot, ankle and hand implant syst...
Medical Implants·169 affected·Jun 27, 2016
High RiskFDA
Conmed Corporation
CORE¿ Suction Irrigation Handpiece without Probe for Single Solution Bags, Catalog Number CD8300 The CORE Trumpet (CD81XX, CD83XX, and C...
Medical Devices·0 affected·Jun 27, 2016
High RiskFDA
Conmed Corporation
CORE¿ Suction Irrigation Handpiece with 5mm x 32cm Length Probe for Single Solution Bags, Catalog Number CD8185 The CORE Trumpet (CD81XX...
Medical Devices·0 affected·Jun 27, 2016
High RiskFDA
Conmed Corporation
CORE¿ Trumpet Handpiece only, Catalog Number CD8450 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological lapa...
Medical Devices·0 affected·Jun 27, 2016
High RiskFDA
Zimmer Gmbh
V-TEK TWIST D 40X90MM 30MM Cann 12MM Rnd; The twist drill is used to drill holes into bones/tissues for foot, ankle and hand implant syst...
Medical Implants·169 affected·Jun 27, 2016
High RiskFDA
Conmed Corporation
CORE¿ Suction Irrigation Handpiece without Probe for Single Solution or Dual Bags, Catalog Number CD8302 The CORE Trumpet (CD81XX, CD83X...
Medical Devices·0 affected·Jun 27, 2016
High RiskFDA
Cardinal Health
The 9025TRU Arterial Blood Gas (ABG) Kit is used to obtain arterial blood sampling for pH, Blood Gas, Electrolyte and Metabolite Analysis.
Medical Devices·884,993 affected·Jun 27, 2016
High RiskFDA
Teva North America
Amoxicillin for Oral Suspension USP, 400 mg/ 5 mL, 50 mL bottle, Rx only, Manufactured In Canada by: Teva Canada Limited, Toronto, Canada...
Oral Drugs·53,328 affected·Jun 24, 2016
High RiskFDA
Danville Materials, Inc.
Perioscopy Sheath: Part number: 1008; The Perioscopy Sheath is a single-use sterile component used with the Perioscopy System, wh...
Medical Devices·2,123 affected·Jun 24, 2016
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
2.3MM Tapered Router, Product Number 5407-FA2-023 A router is a cutting accessory used in the following medical applications: Neuro; Sp...
Medical Devices·3,163 affected·Jun 24, 2016
High RiskFDA
Perkinelmer, Inc
Perkin Elmer RoboRack 25ul, Clear, Non-Conductive, Filter Tips, Pre-sterilized Item Number: 6000689. Supplied for use with JANUS Auto...
Medical Devices·595 affected·Jun 24, 2016
High RiskFDA
Becton, Dickinson And Company, Bd Biosciences
BD Trucount Tubes: Catalog number: 340334 Hematology: BD Trucount tubes are used for determining absolute counts of leucocytes in...
Medical Devices·328 affected·Jun 24, 2016
High RiskFDA
Mondelez International
Nabisco Honey Maid Teddy Grahams Cinnamon Cubs Graham Snacks Net Wt .5 oz (14g) Distributed by Mondelez Global LL East Hanover, NJ 07936...
Snacks & Candy·544 affected·Jun 23, 2016
High RiskFDA
Hospira Inc.
Diazepam Injection USP 10mg/2mL (5 mg/mL, 2 mL), Rx only, Hospira Inc. Lake Forest, IL 60045, NDC 0409-1273-32
Injectable Drugs·373,850 affected·Jun 23, 2016
High RiskFDA
The Metrix Company
AUTOCOMP6 XPS High Speed Compounder REF 58810
Medical Devices·16 affected·Jun 23, 2016
High RiskFDA
The Metrix Company
AUTOCOMP6 High Speed Compounder
Medical Devices·323 affected·Jun 23, 2016
High RiskFDA
The Metrix Company
AUTOCOMP6 XP High Speed Compounder REF 58810
Medical Devices·93 affected·Jun 23, 2016
High RiskFDA
The Metrix Company
Container fill and transfer sets, automatic fill compatible, 250 mL, 500 mL, 1000 mL, 1500 mL, 2000 mL, 3000 mL, or 4000 mL.
Medical Devices·18,366 affected·Jun 23, 2016
High RiskFDA
Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics Specialty Triathlon Tibial Alignment Handle with Secondary Lock, Non-Sterile, Used to complement or replace the s...
Medical Implants·47 affected·Jun 23, 2016
High RiskFDA
Varian Medical Systems, Inc.
Optical Surface Monitoring System{OSMS, Varian Private Label} This is used on Varian's TrueBeam EDGE; Radiology: The AlignRT Plus syst...
Medical Devices·166 affected·Jun 23, 2016
High RiskFDA
Mindray Ds Usa, Inc. Dba Mindray North America
Mindray DS USA Inc., Passport Series Patient Monitor intended for monitoring, displaying, reviewing, alarming, and transferring of multip...
Cardiac Devices·360 affected·Jun 23, 2016
High RiskFDA
Olympus Corporation Of The Americas
OER-Pro Endoscope Reprocessor, Endoscope washer/disinfector
Medical Devices·2 affected·Jun 23, 2016
High RiskFDA
Varian Medical Systems, Inc.
Optical Surface Monitoring System{Align RT Plus} This is used on Varian's TrueBeam EDGE; Radiology: The AlignRT Plus system is indicat...
Medical Devices·21 affected·Jun 23, 2016
High RiskFDA
Philips Medical Systems Nederlands
Philips Allura Xper System: Interventional Fluoroscopic X-Ray System Product No.: 722026, 722027, 722028, 722029, 722035, 722038, and 72...
Medical Devices·42 affected·Jun 23, 2016
High RiskFDA
The Metrix Company
Container fill and transfer sets, 250 mL, 500 mL, 1000 mL, 2000 mL, 3000 mL, or 4000 mL.
Medical Devices·137,598 affected·Jun 23, 2016
High RiskFDA
Medtronic Neuromodulation
DBS Pocket Adaptor, Model 64001 and Model 64002. The Medtronic Models 64001 (1x4) and 64002 (2x4) Pocket Adaptors can be used as a par...
Medical Implants·7,542 affected·Jun 23, 2016
High RiskFDA
The Metrix Company
Dual Chamber Container fill with gravity/attached transfer sets, 250 mL / 1250 mL, 300 mL / 1700 mL, 500 mL / 2500 mL, 500 mL / 3500 mL
Medical Devices·18,474 affected·Jun 23, 2016
High RiskFDA
Wm Bolthouse Farms Inc
Bolthouse Farms Strawberry Protein Plus: 30 g protein per bottle + 21 vitamins & minerals. Packaged in 15.2 oz/450 mL item number: PPC...
Beverages·3,814,275 affected·Jun 22, 2016
High RiskFDA
Wm Bolthouse Farms Inc
Bolthouse Farms Coffee Protein Plus: 30 g protein per bottle + 21 vitamins & minerals. Packaged in 11 oz./325 mL - item number PPJ3BF9;...
Beverages·3,814,275 affected·Jun 22, 2016
High RiskFDA
Wm Bolthouse Farms Inc
Bolthouse Farms Banana Honey Almond Butter Protein Plus: 30 g protein per bottle + 21 vitamins & minerals. Packaged in 11 oz/450 mL it...
Dairy·1,377,483 affected·Jun 22, 2016
High RiskFDA
Wm Bolthouse Farms Inc
Bolthouse Farms Vanilla Bean Protein Plus: 30 g protein per bottle + 21 vitamins & minerals. Packaged in 11 oz./325 mL - item number PP...
Beverages·3,814,275 affected·Jun 22, 2016
High RiskFDA
Wm Bolthouse Farms Inc
Bolthouse Farms Mocha Cappuccino Perfectly Protein : 30 g protein per bottle + 21 vitamins & minerals. Packaged in 15.2 oz/946 mL.- it...
Beverages·3,814,275 affected·Jun 22, 2016
High RiskFDA
Wm Bolthouse Farms Inc
Bolthouse Farms Coconut Protein Plus: 30 g protein per bottle + 21 vitamins & minerals. Packaged in 15.2 oz/450 mL item number: PPCN4B...
Beverages·3,814,275 affected·Jun 22, 2016
High RiskFDA
Starlight Creatives, Inc.
Star shaped, blue frosted tea cookies. The cookies were delivered in plain white pastry boxes and sold unpackaged at the supermarket on...
Bakery & Grains·0 affected·Jun 22, 2016
High RiskFDA
Northern Tier Bakery (dba\ Super Mom's)
The Cheese & Berries Danish was labeled Pleasant Hill Ovens, Cheese Danish, Artificial Flavored, Net WT 5.0 OZ (142 g), UPC 7 63913 13003 4.
Dairy·840 affected·Jun 22, 2016
High RiskFDA
Teva North America
Albuterol Sulfate Syrup, 2 mg/ 5 mL, 473 mL bottle, Rx only, Manufactured in Canada by Contract Pharmaceuticals Limited, Canada, Manufact...
Drugs·8,052 affected·Jun 22, 2016
High RiskFDA
Mylan Pharmaceuticals Inc.
Alprazolam Extended-release Tablets, USP, 1 mg, 60-count bottle, Rx Only, Manufactured and Distributed by: Mylan Pharmaceuticals Inc., ...
Oral Drugs·24,176 affected·Jun 22, 2016
High RiskFDA
Draeger Medical, Inc.
Babytherm 8004/8010, Infant Warmer, Class II device, 510 K K971198, Catalog # FR00105 (Babytherm 8010), 2M30404 (Babytherm 8004), non ste...
Medical Devices·1,599 affected·Jun 22, 2016
High RiskFDA
Lemaitre Vascular, Inc.
AnastoClip AC 8cm 35 Clips (1 Each} Large REF # 4000-07 The Anastoclip Clip applier consists of a rotating shaft and an integral car...
Medical Devices·471 affected·Jun 22, 2016