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High RiskFDA
Ferno-washington Inc
Ferno Model 35X PROFlexx Stretchers, one unit per package
Medical Devices·46 affected·Dec 3, 2014
High RiskFDA
Trumpf Medical Systems, Inc.
IR remote control JUPITER / TS7500, Material no.1601927, Serial number: to (incl.) 102222333. Patient positioning during surgery, rangin...
Medical Devices·3,303 affected·Dec 3, 2014
High RiskFDA
Renew Life Formulas, Inc.
PureLife Naturals Adult Multi-Plus Multi-Vitamins & Minerals Plus Herbs, 60 Pure Caps HDPE bottle
Supplements·60,781 affected·Dec 2, 2014
High RiskFDA
Renew Life Formulas, Inc.
PureLife Naturals Multi-Action Immunity 90 Pure-Caps HDPE bottle
Food·55,271 affected·Dec 2, 2014
High RiskFDA
Zimmer Trabecular Metal Technology, Inc.
NexGen Complete Knee Solution Monoblock Tibial Provisional / Drill Guide Tibial Size 5 Femoral Size Green / CH Zimmer U.K. Ltd., SN3 4FP...
Medical Devices·8 affected·Dec 2, 2014
High RiskFDA
Biomet, Inc.
Device Brand Name: Sirius Polish Cemented Stem 34B Device Classification Name: prosthesis, hip, semi-constrained, metal/polymer, cemente...
Medical Implants·9 affected·Dec 2, 2014
High RiskFDA
Biomet, Inc.
Sirius Polish Cemented Stem 38C Catalog Number: 51-199335 Lot Number Identification: 141680, 180920 The Biomet's Sirius Femoral Hip ...
Medical Devices·8 affected·Dec 2, 2014
High RiskFDA
Sessions Co. Inc.
Shelled Peanuts, in bulk
Food·2,200 affected·Dec 1, 2014
High RiskFDA
Pea River Peanut Company, Llc
Pea River Raw Shelled Raw Fine Alabama Grown Peanuts, Net Wt. 2.5 lbs
Food·280 affected·Dec 1, 2014
High RiskFDA
Fgf Brands, Inc
Mini Naan Eight (8) nann packaged in coated paper printed board and transparent wrap with a net weight of 12.6 oz (360 g) per package and...
Frozen Food·7,783 affected·Nov 26, 2014
High RiskFDA
Zydus Pharmaceuticals Usa Inc
Benzonatate Capsules, USP, 200 mg, 100-count bottles, Rx only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India; Distributed by: ...
Oral Drugs·58,920 affected·Nov 26, 2014
High RiskFDA
Getinge Disinfection Ab
GETINGE 46-SERIES Medical Washer-Disinfector, Models 46-4 and 46-5, with PACS 300/350 Control Series with dryer --- Class II, exempt from...
Medical Devices·551 affected·Nov 26, 2014
High RiskFDA
Steris Corporation
Harmony¿ vLED Surgical Lighting System, one unit packaged per box The Harmony¿ vLED Surgical Lighting System is a variable pattern, vari...
Surgical Devices·140 affected·Nov 26, 2014
High RiskFDA
Scc Soft Computer
SoftPath Laboratory Information System. Versions 4.3.0.8, 4.3.0.9, 4.3.0.10, 4.3.0.11, 4.3.0.12, 4.3.0.14, 4.3.0.15, and 4.4.0.0
Medical Devices·108 affected·Nov 26, 2014
High RiskFDA
Baxter Healthcare Corp.
Clinimix E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% Dextrose with Calcium) Injections, in CLARITY Dual Chamber Con...
Injectable Drugs·7,220 affected·Nov 25, 2014
High RiskFDA
Nonin Medical, Inc
SenSmart, Regional Oximetry EQUANOX Classic Plus Adult/Pediatric Sensor > 40 kg., Model 8003CA (REF 9824-001, 3-Wavelength), 8004CA (R...
Medical Devices·5,892 affected·Nov 25, 2014
High RiskFDA
St Jude Medical
TactiSys Quartz Pack, PN-004 400. For percutaneous catheter radiofrequency (RF) ablation of atrial cardiac arrhythmias that allows v...
Cardiac Devices·89 affected·Nov 25, 2014
High RiskFDA
Carestream Health Inc
DRX-Revolution Mobile X-Ray System, MODEL DRXR-1, Service Code 1243, Catalog Number 1060177 (China) and 1019397 (all other countries) ---...
Diagnostic Devices·629 affected·Nov 25, 2014
High RiskFDA
Par Pharmaceutical Inc.
HydrALAZINE Hydrochloride Tablets, USP 25 mg, 100 count bottle Rx only, Distributed by: Par Pharmaceutical Companies, Inc. Spring Valley,...
Oral Drugs·38,788 affected·Nov 24, 2014
High RiskFDA
Arthrosurface, Inc.
Arthrosurface 25&30mm 12.5x32mm Taper Post Fixation Component; Catalog Number: 6125-0035, Part Number: 1125-0035. HemiCAP Contoured Arti...
Medical Implants·143 affected·Nov 24, 2014
High RiskFDA
Arthrosurface, Inc.
Arthrosurface HHXL (OVO) 15.6x32mm Taper Post Fixation Component; Catalog Number: 8156-0032, Part Number: 156-0032. HemiCAP Contoured Ar...
Medical Implants·187 affected·Nov 24, 2014
High RiskFDA
Arthrosurface, Inc.
Arthrosurface 35mm 13.5x32mm Taper Post Fixation Component; Catalog Number: 8135-0032, Part Number: 3135-0032. HemiCAP Contoured Articul...
Medical Implants·138 affected·Nov 24, 2014
High RiskFDA
Arthrosurface, Inc.
Athrosurface 40mm 13.75x31mm Taper Post Fixation Component; Catalog Number: 8135-1875 Part Number: 3135-1875. HemiCAP Contoured Articu...
Medical Implants·182 affected·Nov 24, 2014
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista Myoglobin Calibrator (MYO CAL), Lot 4FD085 Product usage: in vitro diagnostic product for the calibration of Myoglobi...
Diagnostic Devices·1,230 affected·Nov 24, 2014
High RiskFDA
Arthrosurface, Inc.
Arthrosurface 25&30mm 10.5x28mm Taper Post Fixation Component; Catalog Number: 6105-0028, Pat Number 1105-0028. HemiCAP Contoured Artic...
Medical Implants·136 affected·Nov 24, 2014
High RiskFDA
Kozy Shack Inc
KOZY SHACK SIMPLY WELL CHOCOLATE, NET WT 4 OZ. Product packed in brown carton box, 48 individual units x 4 OZ. Keep Refrigerated. Made...
Snacks & Candy·1,774 affected·Nov 21, 2014
High RiskFDA
Teleflex, Inc.
Carlens Bronchial Double Lumen Tube Set (Left) Sterile
Medical Devices·0 affected·Nov 21, 2014
High RiskFDA
Teleflex, Inc.
Bronchial Double Lumen Tube Set (Right), Sterile
Medical Devices·0 affected·Nov 21, 2014
High RiskFDA
Intuitive Surgical, Inc.
Fluorescence Imaging Procedure Kit, designed for use with Firefly Fluorescence Imaging for the da Vinci Xi 4000 Surgical Systems. The In...
Surgical Devices·1,532 affected·Nov 21, 2014
High RiskFDA
Intuitive Surgical, Inc.
Fluorescence Imaging Procedure Kit, designed for use with Firefly Fluorescence Imaging for the da Vinci Si 3000 Surgical Systems. The In...
Surgical Devices·1,532 affected·Nov 21, 2014
High RiskFDA
Tomotherapy Incorporated
TomoTherapy Treatment System with software versions 2.0.1 / 2.0.2 / 2.0.3/ (Hi:Art 5.0.1 / 5.0.2 / 5.0.3)
Medical Devices·210 affected·Nov 21, 2014
High RiskFDA
Atricure Inc
Cryogenic probe for cardiac ablation surgery, packaged individually in Tyvek pouches Product Usage: Cryogenic probe for cardiac ablat...
Cardiac Devices·19,190 affected·Nov 21, 2014
High RiskFDA
Becton Dickinson & Co.
BBL Port A Cul tubes with Swabs Sterile Pack, catalog number 221607. For patient sample collection.
Medical Devices·92,710 affected·Nov 21, 2014
High RiskFDA
Teleflex, Inc.
Bronchial One Lumen Tube - Left
Medical Devices·0 affected·Nov 21, 2014
High RiskFDA
Smiths Medical Asd, Inc.
Hypodermic Needle Pro¿ Edge" Safety Device with Syringe 20G x1 10mL Luer lock syringe; Reorder Number: 4102010 Product Usage: The Nee...
Medical Devices·47,200 affected·Nov 21, 2014
High RiskFDA
Teleflex, Inc.
Bronchial Double Lumen Tube Set (Left), Sterile
Medical Devices·6,991 affected·Nov 21, 2014
High RiskFDA
Smiths Medical Asd, Inc.
Hypodermic Needle Pro¿ Edge" Safety Device 20G x1; Reorder Number: 402010 Product Usage: The Needle Pro¿ Edge Safety Hypodermic Need...
Medical Devices·334,000 affected·Nov 21, 2014
High RiskFDA
Teleflex, Inc.
Bronchial One Lumen Tube - Right
Medical Devices·0 affected·Nov 21, 2014
High RiskFDA
Zimmer Manufacturing B.v.
Bone Screw, self-tapping The Trilogy shells are available in three configurations; uni, multi, and cluster-holed. The multi and cluster-...
Medical Devices·6,377 affected·Nov 21, 2014
High RiskFDA
Teleflex, Inc.
Tracheopart Set (Right), Sterile
Medical Devices·0 affected·Nov 21, 2014
High RiskFDA
Flying Cow Creamery
whole milk yogurt is packaged in a 32 oz. glass jar, sold under brand Flying Cow Creamery. The UPC is 7 13757 87133 4. The product is...
Dairy·117 affected·Nov 20, 2014
High RiskFDA
One And Zen
GINSENG KIANPI PIL, 60 capsules, PRODUCT OF KWEILIN DRUG MANUFACTORY
Oral Drugs·38 affected·Nov 20, 2014
High RiskFDA
Roche Diagnostics Operations, Inc.
ACCU-CHEK Tender II 13/110 10 + 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the...
Surgical Devices·13,041 affected·Nov 20, 2014
High RiskFDA
Roche Diagnostics Operations, Inc.
ACCU-CHEK Tender I 17/80 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surfac...
Surgical Devices·13,041 affected·Nov 20, 2014
High RiskFDA
Roche Diagnostics Operations, Inc.
ACCU-CHEK Tender II 17/80 10 + 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the ...
Surgical Devices·13,041 affected·Nov 20, 2014
High RiskFDA
Philips Medical Systems, Inc.
Lithium Polymer Fiber Optic Module Batteries used in the Intera MR System upgraded to CDAS, Part Number: 9065 and 9067. These rechargeab...
Medical Devices·79 affected·Nov 20, 2014
High RiskFDA
Roche Diagnostics Operations, Inc.
ACCU-CHEK Tender I 17/60 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surfac...
Surgical Devices·13,041 affected·Nov 20, 2014
High RiskFDA
Roche Diagnostics Operations, Inc.
ACCU-CHEK¿ Tender I 13/60 10 pieces Product Usage: Usage: Intended for the infusion and/or injection of fluids into the body below t...
Surgical Devices·13,041 affected·Nov 20, 2014