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High RiskFDA
Magic Gourmet Trading Inc
Koi Palace Mini Moon Cake: Mini Fresh Five Nuts with Smoked Ham Unit Size 1/2 lb. and 1/4 lb. in circular box (1 piece) and rectangular ...
Bakery & Grains·4 affected·Aug 31, 2016
High RiskFDA
Magic Gourmet Trading Inc
Koi Palace Mini Moon Cake: Single Box - Mini Walnut, Red Bean Paste Unit Size 1/2 lb. and 1/4 lb. in circular box (1 piece) and rectangu...
Bakery & Grains·2 affected·Aug 31, 2016
High RiskFDA
Ormco/sybronendo
Sealapex Xpress, Part No. 33639 The brand name of the device is Sealapex Xpress, a root canal filling resin. Sealapex Xpress is intend...
Medical Devices·179 affected·Aug 31, 2016
High RiskFDA
Neusoft Medical Systems Co., Ltd.
NeuViz 64 Multi-slice CT Scanner Systems
Medical Devices·23 affected·Aug 31, 2016
High RiskFDA
Pao De Milho Iii, Llc
Triana Family Brioche Donuts Bavarian Cream Net Wt. 0.75 LBS (340 g) 12 -24 Jabez St., Newark, NJ 07106 UPC 000260003995 packaged in ...
Dairy·60 affected·Aug 30, 2016
High RiskFDA
Bimbo Bakeries Usa Inc.
Entenmann's Little Bites Variety - 20 pouches labeled for resale 10 Chocolate Chip; 5 Blueberry; 5 Fudge Brownie; Net Wt 2 lbs.; Distr...
Snacks & Candy·45,600 affected·Aug 30, 2016
High RiskFDA
Bimbo Bakeries Usa Inc.
Entenmann's Little Bites Fudge Brownies - 20 muffins, 5 Pouches; Net Wt. 9.75 OZ.; Bimbo Bakeries USA, Inc., Horsham, PA 19044; Best By: ...
Food·244,704 affected·Aug 30, 2016
High RiskFDA
Bimbo Bakeries Usa Inc.
Entenmann's Little Bites Chocolate Chip Muffins; 10 Pouches; Net Wt. 1 lb. 0.5 OZ. ; Bimbo Bakeries USA, Inc.; PO #976, Horsham, PA 19044...
Snacks & Candy·10 affected·Aug 30, 2016
High RiskFDA
Ergosafe Products, Llc (dba) Prism Medical
Carry bar which is an accessory to a lift used for patients in hospitals and other facilities. Recall impacts the following model number...
Medical Devices·17,964 affected·Aug 30, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
IMMULITE/ IMMULITE 1000 Systems CMM CMV IgM Assay, REF/Catalog Number LKCM1(D) - 100 tests (US), Siemens Material Number (SMN) 10370301 (...
Diagnostic Devices·5 affected·Aug 30, 2016
High RiskFDA
Angiodynamics Inc. (navilyst Medical Inc.)
BioFlo PICC with ENDEXO and PASV Valve Technology Maximal Barrier Nursing Kit - UPN # H965750191/Catalog No:75-019 The BioFlo PICCs with...
Medical Devices·200 affected·Aug 29, 2016
High RiskFDA
Smith & Nephew, Inc.
TANDEM (TM) COCR SHELL UHMWPE LINER BIPOLAR, REF NUMBERS: 71322040, 71322041, 71322042, 71322043, 71322044, 71322045, 71322046, 7132...
Medical Devices·2,352 affected·Aug 29, 2016
High RiskFDA
Smith & Nephew, Inc.
TANDEM (TM) INTL COCR SHELL UHMWPE LINER BIPOLAR, REF NUMBERS: 71324038, 71324039, 71324040, 71324041, 71324042, 71324043, 71324044,...
Medical Devices·5,806 affected·Aug 29, 2016
High RiskFDA
Ldr Spine Usa, Inc.
ROI-A Anterior Delivery Device. Orthopedic manual surgical instrument. Model number: SI-ROIA-0023 Auxiliary instrument used in the RO...
Surgical Devices·24 affected·Aug 29, 2016
High RiskFDA
Angiodynamics Inc. (navilyst Medical Inc.)
BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit - 1) UPN # H965750121/Catalog No: 5018265, 2) UPN # H965750131/Catalog N...
Medical Devices·153 affected·Aug 29, 2016
High RiskFDA
Trimed Inc
TriMed Semi-Tubular Plate, 10-Hole, Model No. SMTP-10 Contoured plate with offset screw holes. The plate is 103 mm in length, 1.3 mm t...
Surgical Devices·30 affected·Aug 29, 2016
High RiskFDA
Angiodynamics Inc. (navilyst Medical Inc.)
Xcela Power Injectable PICC Maximal Barrier Nursing Kit The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with ...
Medical Devices·75 affected·Aug 29, 2016
High RiskFDA
Westby Coop Creamery
4% cottage cheese packaged in 16-ounce, 22-ounce, and 24-ounce plastic containers; under the Westby, Food Club, Oberweis, and Shurfine br...
Dairy·695 affected·Aug 27, 2016
High RiskFDA
Victory General Foods Inc
ELDER PAINTSIL'S GA KENKEY, NET WT. 1.20, UPC: 6 61799 58166 0, MANUFACTURED BY VICTORY GENERAL FOODS IN WORCESTER, MA 01603
Food·0 affected·Aug 26, 2016
High RiskFDA
Abbott Medical Optics Inc. (amo)
TECNIS OptiBlue 1-Piece Intraocular Lens (IOL), Model No. ZCB00V The product is indicated for implantation for the visual correction of ...
Medical Implants·131 affected·Aug 26, 2016
High RiskFDA
The Anspach Effort, Inc.
G1 Dissection Tool - 3mm CRS DBALL, 2mm SHAFT EXP, M; For cutting and shaping bone including spine and cranium.
Medical Devices·88 affected·Aug 26, 2016
High RiskFDA
Abbott Medical Optics Inc. (amo)
TECNIS 1-Piece IOL with the TECNIS iTec Preloaded Delivery System, Model No. PCB00 The product is indicated for implantation for the vis...
Medical Implants·217 affected·Aug 26, 2016
High RiskFDA
Abbott Medical Optics Inc. (amo)
TECNIS Symfony Extended Range of Vision IOL, Model No. ZXR00 The product is indicated primary implantation for the visual correction of ...
Medical Implants·10 affected·Aug 26, 2016
High RiskFDA
Abbott Medical Optics Inc. (amo)
SENSAR Foldable IOL with OptiEdge Design, Model No. AR40e The product is indicated for implantation for the visual correction of aphakia...
Medical Implants·84 affected·Aug 26, 2016
High RiskFDA
The Anspach Effort, Inc.
G1 Dissection Tool - 3mm FLUTED BALL; For cutting and shaping bone including spine and cranium.
Medical Devices·63 affected·Aug 26, 2016
High RiskFDA
Abbott Medical Optics Inc. (amo)
SENSAR 1-Piece IOL, Model No. AAB00 The product is indicated for implantation for the visual correction of aphakia in adult patients in ...
Medical Implants·1 affected·Aug 26, 2016
High RiskFDA
The Anspach Effort, Inc.
G1 Dissection Tool - 6MM CRS DBALL, 2mm Shaft EXP, M; For cutting and shaping bone including spine and cranium.
Medical Devices·69 affected·Aug 26, 2016
High RiskFDA
The Anspach Effort, Inc.
G1 Dissection Tool - 7mm FBALL L; For cutting and shaping bone including spine and cranium.
Medical Devices·177 affected·Aug 26, 2016
High RiskFDA
Abbott Medical Optics Inc. (amo)
TECNIS Multifocal Foldable Acrylic Intraocular Lens, Model No. ZMA00 The product is indicated for primary implantation for the visual co...
Medical Implants·41 affected·Aug 26, 2016
High RiskFDA
Spacelabs Healthcare Inc
Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280. Xhibit Telemetry Receivers (XTR) must be connected to an Xhibit Centr...
Medical Devices·316 affected·Aug 25, 2016
High RiskFDA
Merit Medical Systems, Inc.
Merit Inflation Syringe Kit. Catalog Number KOS-02857
Medical Devices·1,297 affected·Aug 25, 2016
High RiskFDA
Natus Medical Incorporated
The Medix NatalCare LX Intensive Care Incubator. Neonatal incubator. Item numbers: DMNCLX1; KITNC-STLX0003; KITNC-STLX0006; and KITNC-S...
Medical Devices·104 affected·Aug 25, 2016
High RiskFDA
United Nuclear Scientific Supplies, Llc
United Nuclear Scientific High Power Handheld Lasers. Laser products
Medical Devices·3 affected·Aug 25, 2016
High RiskFDA
Spacelabs Healthcare Inc
Spacelabs Healthcare Xhibit Central Station, Model 96102, Version 1.1.2. Xhibit Telemetry Receivers (XTR) must be connected to an Xhibi...
Medical Devices·798 affected·Aug 25, 2016
High RiskFDA
Amerisource Health Services
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Sin...
Oral Drugs·666 affected·Aug 24, 2016
High RiskFDA
Amerisource Health Services
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts ...
Oral Drugs·867 affected·Aug 24, 2016
High RiskFDA
Amerisource Health Services
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts ...
Oral Drugs·221 affected·Aug 24, 2016
High RiskFDA
Amerisource Health Services
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Sin...
Oral Drugs·115 affected·Aug 24, 2016
High RiskFDA
Sandoz Inc
Transderm Scop (scopolamine) Transdermal System, 1.5 mg, 24 patches Multi pack, Rx only, Marketed by Baxter Healthcare Cop/Novartis, Deer...
Topical Drugs·42,740 affected·Aug 24, 2016
High RiskFDA
Sandoz Inc
Phenylephrine HCI Injection, USP, 10mg/mL, packaged in a) 5 mL Vial, 50 mg/5 mL (NDC 66758-016-03), 25 x 5 mL Vials per carton (NDC 66758...
Injectable Drugs·1,584 affected·Aug 24, 2016
High RiskFDA
Amerisource Health Services
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Sin...
Oral Drugs·834 affected·Aug 24, 2016
High RiskFDA
Amerisource Health Services
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Sin...
Oral Drugs·761 affected·Aug 24, 2016
High RiskFDA
Sandoz Inc
Ephedrine Sulfate Injection, USP, 50 mg/mL, 1 mL Fill in a 2mL Vial (NDC 66758-008-01), packaged in 25 x 2 mL Vials per carton (NDC 66758...
Injectable Drugs·32,099 affected·Aug 24, 2016
High RiskFDA
Amerisource Health Services
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Sin...
Oral Drugs·126 affected·Aug 24, 2016
High RiskFDA
Amerisource Health Services
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts ...
Oral Drugs·1,416 affected·Aug 24, 2016
High RiskFDA
Amerisource Health Services
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts ...
Oral Drugs·156 affected·Aug 24, 2016
High RiskFDA
Amerisource Health Services
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts ...
Oral Drugs·2,276 affected·Aug 24, 2016
High RiskFDA
Integra Lifesciences Corp. D.b.a. Integra Pain Management
PHS Spinal Tray 24G Gertie Marx, Catalogue No. 899379. Intended to provide licensed medical professionals with a kit containing drugs ...
Medical Devices·320 affected·Aug 24, 2016