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High RiskFDA
Coopervision Inc.
ClearSight(TM) Toric 1 day (ocufilcon D), 30 daily disposable contact lenses for astigmatism, STERILE, Rx only --- CooperVision Hamble, S...
Medical Devices·45 affected·Nov 20, 2013
High RiskFDA
Nexgen Pharma, Inc.
PCC, Rebecca's Natural Food, Sprouts Famous Market, Ritzman Pharmacy, Earth Fare, Hartig Drug, Viroqua Food, Ramona Fitness Center, Indep...
Supplements·88 affected·Nov 19, 2013
High RiskFDA
Asante Solutions, Inc.
Asante Conset Infusion Set with 60cm tubing & 9mm cannula packaged in 5-packs,singles, or inside a Combination Kit (FG-5229-4); Distribu...
Medical Devices·1,979 affected·Nov 19, 2013
High RiskFDA
Atrium Medical Corporation
Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System with stopcock and in-line connectors; Product Code: 2050...
Medical Devices·10,448 affected·Nov 19, 2013
High RiskFDA
Asante Solutions, Inc.
Asante Comfort Infusion Set with 110cm tubing & 17mm cannula packaged in 5-packs, singles, or inside a Combination Kit (FG-5147-4). ...
Medical Devices·352 affected·Nov 19, 2013
High RiskFDA
Atrium Medical Corporation
Atrium Oasis Dry Suction Water Seal ATS (Autotransfusion) Blood Recovery System Chest Drain Dual patient lines; Product Code: 3652-100...
Medical Devices·954 affected·Nov 19, 2013
High RiskFDA
Asante Solutions, Inc.
Asante Comfort Infusion Set with 60cm tubing & 17mm cannula packaged in 5-packs, singles,or inside a Combination Kit (FG-5127-4). Manu...
Medical Devices·246 affected·Nov 19, 2013
High RiskFDA
Asante Solutions, Inc.
Asante Comfort Infusion Set with 60cm tubing & 13mm cannula packaged in 5-packs, singles,or inside a Combination Kit (FG-5123-4) Manuf...
Medical Devices·834 affected·Nov 19, 2013
High RiskFDA
Atrium Medical Corporation
Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System Dual patient lines with stopcock and in-line connectors...
Medical Devices·361 affected·Nov 19, 2013
High RiskFDA
Asante Solutions, Inc.
Asante Conset Infusion Set with 110cm tubing & 6mm cannula packaged in 5-packs, singles,or inside a Combination Kit (FG-5246-4) Distri...
Medical Devices·454 affected·Nov 19, 2013
High RiskFDA
Atrium Medical Corporation
Atrium Oasis Dry Suction Water Seal ATS (Autotransfusion) Blood Recovery System Chest Drain with in-line connectors Product Code: 3650-...
Medical Devices·42,699 affected·Nov 19, 2013
High RiskFDA
Zimmer, Inc.
NexGen Complete Knee Solution Porous Patella Drill Guide-26mm dia./10mm thickness Non sterile, Rx Only Devices are used in total kne...
Surgical Devices·625 affected·Nov 19, 2013
High RiskFDA
Atrium Medical Corporation
Atrium Express Dry Seal ATS (Autotransfusion) Blood Recovery System Chest Drain with Prefilled Air Leak Monitor; Product Code: 4050-100P...
Medical Devices·1,944 affected·Nov 19, 2013
High RiskFDA
Atrium Medical Corporation
Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System Dual patient lines with stopcock; .Product Code: 2052-3...
Medical Devices·1,002 affected·Nov 19, 2013
High RiskFDA
Zimmer, Inc.
NexGen Complete Knee Solution CR Articular Surface Provisional-Yellow 9mm Height Nonsterile Devices are used in total knee arthroplas...
Surgical Devices·684 affected·Nov 19, 2013
High RiskFDA
Zimmer, Inc.
NexGen Complete Knee Solution CR Articular Surface Provisional-Purple 9mm Height Nonsterile Devices are used in total knee arthropla...
Surgical Devices·638 affected·Nov 19, 2013
High RiskFDA
Asante Solutions, Inc.
Asante Conset Infusion Set with 60cm tubing & 6mm cannula packaged in 5-packs,singles,or inside a Combination Kit (FG-5226-4) Distribu...
Medical Devices·1,392 affected·Nov 19, 2013
High RiskFDA
Atrium Medical Corporation
Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System with stopcock Blood Recovery System; Product Code: 2050-3...
Medical Devices·6,684 affected·Nov 19, 2013
High RiskFDA
Zimmer, Inc.
NexGen Complete Knee Solution Porous Patella Drill Guide-29mm dia./10mm thickness Non sterile, Rx Only Devices are used in total kne...
Surgical Devices·641 affected·Nov 19, 2013
High RiskFDA
Atrium Medical Corporation
Atrium Express Dry Seal ATS (Autotransfusion) Blood Recovery System Chest Drain; Product Code: 4050-100N. To evacuate air and/or flu...
Medical Devices·7,274 affected·Nov 19, 2013
High RiskFDA
Flora Inc
Flora Double Ginger Herbal Tea Blend, 16/1.24 oz (35.2g) tea bags per package. UPC 0 61998 63757 9 The product is labeled in parts: "...
Beverages·6,024 affected·Nov 18, 2013
High RiskFDA
Depuy Orthopaedics, Inc.
SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibi...
Medical Devices·29,235 affected·Nov 18, 2013
High RiskFDA
Depuy Orthopaedics, Inc.
SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibi...
Medical Devices·29,235 affected·Nov 18, 2013
High RiskFDA
Depuy Orthopaedics, Inc.
SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial ...
Medical Devices·29,235 affected·Nov 18, 2013
High RiskFDA
Varian Medical Systems, Inc.
Plan Parameters workspace within Eclipse Treatment Planning System Version 11 and 13; ARIA Radiation Oncology versions 11 and 13 Acuit...
Medical Devices·6,701 affected·Nov 18, 2013
High RiskFDA
Depuy Orthopaedics, Inc.
SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED SIZE 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proxima...
Medical Devices·29,235 affected·Nov 18, 2013
High RiskFDA
Depuy Orthopaedics, Inc.
SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proxim...
Medical Devices·29,235 affected·Nov 18, 2013
High RiskFDA
Depuy Orthopaedics, Inc.
SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal...
Medical Devices·29,235 affected·Nov 18, 2013
High RiskFDA
Medtronic Neurosurgery
Medtronic Delta Shunt Assembly Kit with Bioglide Small, Performance Level 1.0, Catalog No. 276201. Delta Shunt Assemblies are designe...
Medical Devices·34 affected·Nov 18, 2013
High RiskFDA
Medtronic Neurosurgery
Medtronic Strata II Shunt Assembly Kit, Small, Catalog No. 27848. Strata II Shunt Assemblies are designed to provide continued cerebr...
Cardiac Devices·5 affected·Nov 18, 2013
High RiskFDA
Cmp Industries, Llc
IMPAK ACRYLIC RESIN LIQUID FOR BOTH IMPAK & IMPAK-PF POWDERS 1 qt. size (946 cc), Part Number 3306, and 11 oz. size (325 cc), Part Number...
Medical Devices·246 affected·Nov 18, 2013
High RiskFDA
Medtronic Neurosurgery
CSF-Unitized Shunt, Contoured Regular, Low Pressure, Catalog No. 46022; CSF-Unitized Shunt, Contoured Regular, Medium Pressure, Catalog ...
Medical Devices·288 affected·Nov 18, 2013
High RiskFDA
Pinnacle Foods, Llc
Aunt Jemima(R) HOMESTYLE FRENCH TOAST, 6 COUNT, NET WT. 12.5 OZ (354 g), UPC Code: 019600057703
Food·153 affected·Nov 17, 2013
High RiskFDA
Lewis Bakeries-evansville
White bread packaged under the following names and sizes: UPC Name, size 71025-00269 Holsum, Sof-Twist, Giant, 24 OZ 24126-010...
Bakery & Grains·365,847 affected·Nov 16, 2013
High RiskFDA
Lewis Bakeries-evansville
UPC Name 6000050617 French Toast Whole Wheat (bulk)
Food·19,890 affected·Nov 16, 2013
High RiskFDA
Lewis Bakeries-evansville
Whole Wheat Bread packaged under the following names and sizes: UPC Name, size 41498-18997 L'Oven Fresh, Wheat Sandwich, 20 OZ ...
Bakery & Grains·111,807 affected·Nov 16, 2013
High RiskFDA
Lewis Bakeries-evansville
UPC Name 6000283494 Yellow bread (bulk)
Bakery & Grains·87,210 affected·Nov 16, 2013
High RiskFDA
Lewis Bakeries-evansville
UPC Name 6000283495 Cinnamon Bread (bulk)
Bakery & Grains·18,360 affected·Nov 16, 2013
High RiskFDA
Tower Pharmacy And Compounding
Phenylephrine Nasal 1% Spray, 480 mL bottles, For Office Use, Tower Pharmacy, 26732 Crown Valley Pkwy, Suite 101, Mission Viejo, CA 92691
Inhaled / Nasal Drugs·2 affected·Nov 16, 2013
High RiskFDA
Kirkman Group Inc.
Phenol Assist, Kirkman brand, Item # 0835-090
Food·1,774 affected·Nov 15, 2013
High RiskFDA
Physique Enhancing Science
Physique Enhancing Science ALPHAMINE, Powerful Thermogenic Powder, DIETARY SUPPLEMENT Net Wt. 8.9 oz (252 g). Raspberry Lemonade and Frui...
Produce·12,363 affected·Nov 15, 2013
High RiskFDA
Kirkman Group Inc.
EnZym-Complete/DPP-IV II with Isogest, Kirkman brand. Item numbers: 0851A-090, 0851A-180, 0931-090, 0931-180, 5851A-090, 5931-090.
Food·9,486 affected·Nov 15, 2013
High RiskFDA
Lotus Foods Inc
Organic Jade Pearl RICE RAMEN; Gluten Free/Vegan, Infused Noodles Ready in 4 minutes; Net Wt. 10 oz; (283 g) ramen per bag USDA Organ...
Food·8,496 affected·Nov 15, 2013
High RiskFDA
Kirkman Group Inc.
Enzym-Complete/DPP-IV, Kirkman brand. Item numbers 0234-060, 0234-120, 0234-200, 5234-200
Food·11,944 affected·Nov 15, 2013
High RiskFDA
Lotus Foods Inc
Organic Millet & Brown RICE RAMEN; Gluten Free/Vegan Ready in 4 minutes; Net Wt. 10 oz; (283g) 4 ramen per bag USDA Organic; Lotus ...
Food·8,568 affected·Nov 15, 2013
High RiskFDA
Kirkman Group Inc.
Chewable Maximum Spectrum EnZym-Complete/DPPIV with Isogest, Kirkmand brand. Item # 0893-090
Food·79 affected·Nov 15, 2013
High RiskFDA
Physique Enhancing Science
Physique Enhancing Science ENHANCED, Ultra Advanced Pre-Workout, DIETARY SUPPLEMENT Net Wt. 5.22 oz (148 g). In BlueRazz and Fruit Punch...
Produce·28,804 affected·Nov 15, 2013
High RiskFDA
Lotus Foods Inc
Jade Pearl RICE RAMEN with miso soup Gluten Free/Reduced Sodium; made with organic rice Ready in 4 minutes; Net Wt.2.8 oz. (80 g) 1 Ra...
Food·18,150 affected·Nov 15, 2013