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High RiskFDA
Los Chileros De Nuevo Mexico, Ltd
Los Chileros de nuevo mexico gourmet southwestern cuisine Green Chile Blue Cornbread, 9.84 oz., Los Chileros de Nuevo Mexico, PO Box 6215...
Bakery & Grains·525 affected·Oct 21, 2014
High RiskFDA
Los Chileros De Nuevo Mexico, Ltd
Los Chileros de nuevo mexico gourmet southwestern cuisine Blue Corn Waffle & Pancake Mix, Net Wt. 16 oz (453.6 grams), Los Chileros de Nu...
Bakery & Grains·868 affected·Oct 21, 2014
High RiskFDA
Los Chileros De Nuevo Mexico, Ltd
Los Chileros de nuevo mexico gourmet southwestern cuisine Sopaipilla Mix, Net Wt. 12 oz (340 grams), Los Chileros de Nuevo Mexico, PO Box...
Food·892 affected·Oct 21, 2014
High RiskFDA
Los Chileros De Nuevo Mexico, Ltd
Los Chileros de nuevo mexico gourmet southwestern cuisine Carne Adovada with Sopaipilla Mix, 13 oz.., Los Chileros de Nuevo Mexico, PO Bo...
Food·657 affected·Oct 21, 2014
High RiskFDA
Los Chileros De Nuevo Mexico, Ltd
Los Chileros de nuevo mexico gourmet southwestern cuisine Cream of Green Chile Chicken Soup, 5.92 oz.., Los Chileros de Nuevo Mexico, PO ...
Dairy·897 affected·Oct 21, 2014
High RiskFDA
Medacta Usa
The MectaLIF Oblique Handle, model number 03.22.10.0262, is used to insert the MectaLIF oblique spinal cage implants.
Medical Implants·32 affected·Oct 21, 2014
High RiskFDA
Gyrus Acmi, Incorporated
Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and REF 005280-901 (with 8 mm Disposable Trocan). Sterile EO. Sing...
Medical Devices·74,792 affected·Oct 21, 2014
High RiskFDA
Le Fe Foods, Inc.
La Fe Green Hot Sauce, 5.6 Fl. Oz. - 165 mL, Imported by: G & T Foods, Inc., Moonachie, N.J. 07074, Distributed by: LA FE Foods, Product ...
Food·21 affected·Oct 20, 2014
High RiskFDA
Diamedix Corporation
Diamedix Is-EBV-VCA IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA procedure intended for the qualitative and semi-quantitativ...
Diagnostic Devices·588 affected·Oct 20, 2014
High RiskFDA
Diamedix Corporation
Diamedix Is-EBV-EA-D IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA procedure intended for the qualitative and semi-quantitati...
Diagnostic Devices·94 affected·Oct 20, 2014
High RiskFDA
Pfm Medical Inc
ASEPT Pleural Drainage System, Pleural Drainage Catheter Kit, Ref No. P09080001, M7001 Product Usage: The pfm medical ASEPT Pleural Dr...
Surgical Devices·120 affected·Oct 20, 2014
High RiskFDA
Pfm Medical Inc
6F x 60 cm Dual Lumen CT PICC, Ref No. PFM2CT6D Product Usage:The PFM CT PICC catheter is indicated for short or long term peripheral ...
Surgical Devices·90 affected·Oct 20, 2014
High RiskFDA
Pfm Medical Inc
ASEPT Peritoneal Drainage System, Ref No. P09080002 Product Usage: The pfm medical ASEPT Peritoneal Drainage System is a tunneled, in...
Surgical Devices·83 affected·Oct 20, 2014
High RiskFDA
Pfm Medical Inc
Micro Introducer Kit, 5F Micro Introducer Kit, Ref No. M4005 Product Usage: These introducers are used for the percutaneous introducti...
Surgical Devices·100 affected·Oct 20, 2014
High RiskFDA
Radiometer America Inc
HemoCue¿ Glucose 201 Microcuvettes, The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201Analyzer and t...
Diabetes Devices·3,712,900 affected·Oct 20, 2014
High RiskFDA
Pfm Medical Inc
Veta Peritoneal Catheter Kit, Curled, Ref No. M7225 Product Usage: Veta Peritoneal Dialysis Catheters are intended for acute and chro...
Surgical Devices·85 affected·Oct 20, 2014
High RiskFDA
Biosense Webster, Inc.
ThermoCool SmartTouch Navigation Catheters, Catalog No. D132701, D132702, D132703, D132704, D132705, D133601, D133602, D133603.
Surgical Devices·173,329 affected·Oct 19, 2014
High RiskFDA
Obagi Medical Products
Obagi Nu-Derm Clear, AM PM 3, Skin Bleaching and Corrector Cream, Hydroquinone USP, 4%, Rx Only, Net Wt. 2 OZ. (57 g) bottle, Dist by OMP...
Topical Drugs·975 affected·Oct 17, 2014
High RiskFDA
Aurobindo Pharma Usa Inc
Gabapentin Capsules, USP 300 mg, 100-count bottles, Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141; Manufactured by: Auro...
Oral Drugs·24,816 affected·Oct 17, 2014
High RiskFDA
Biomet Microfixation, Llc
Total Temporomandibular Joint Replacement System- 50mm Rt Standard Ti Mand Reconstruction of the temporomandibular joint
Medical Devices·42 affected·Oct 17, 2014
High RiskFDA
Biomet Microfixation, Llc
Total Temporomandibular Joint Replacement System- 45mm Rt Narrow Ti Mand Reconstruction of the temporomandibular joint
Medical Devices·42 affected·Oct 17, 2014
High RiskFDA
Ino Therapeutics (dba Ikaria)
INOMAX DSIR Nitric Oxide delivery system, Model 10007, software version 3.1.0., delivers INOMAX (nitric oxide for inhalation) therapy gas...
Medical Devices·9 affected·Oct 17, 2014
High RiskFDA
Biomet Microfixation, Llc
Total Temporomandibular Joint Replacement System- 50mm Rt Narrow Ti Mand Reconstruction of the temporomandibular joint
Medical Devices·42 affected·Oct 17, 2014
High RiskFDA
Biomet Microfixation, Llc
Total Temporomandibular Joint Replacement System- 50mm Rt Stand Off Ti Mand Reconstruction of the temporomandibular joint
Medical Devices·42 affected·Oct 17, 2014
High RiskFDA
Ethicon, Inc.
Ethicon PERMA-HAND Silk siliconized black braided 10 strands per packet Ethicon LLC- Made in USA.
Medical Devices·2,508 affected·Oct 17, 2014
High RiskFDA
Remel Inc
Oxoid Legionella BCYE Growth Supplement SR0110A, packaged in 100 ml vials, 10/pkg. A growth supplement for the isolation of Legionella.
Medical Devices·16 affected·Oct 17, 2014
High RiskFDA
Maquet Cardiovascular Us Sales, Llc
Cardiohelp-I System Product Usage: A blood oxygenation and carbon dioxide removal system used to pump blood thorough the extracorpor...
Respiratory Devices·331 affected·Oct 17, 2014
High RiskFDA
Biomet Microfixation, Llc
Total Temporomandibular Joint Replacement System- 45mm Lft Standard Ti Mand Reconstruction of the temporomandibular joint
Medical Devices·42 affected·Oct 17, 2014
High RiskFDA
Biomet Microfixation, Llc
Total Temporomandibular Joint Replacement System- 50mm Lft Narrow Ti Mand Reconstruction of the temporomandibular joint
Medical Devices·42 affected·Oct 17, 2014
High RiskFDA
Biomet Microfixation, Llc
Total Temporomandibular Joint Replacement System- 50mm Lft Standard Ti Mandi Reconstruction of the temporomandibular joint
Medical Devices·42 affected·Oct 17, 2014
High RiskFDA
Biomet Microfixation, Llc
Total Temporomandibular Joint Replacement System- 55mm Lft Standard Ti Mand Reconstruction of the temporomandibular joint
Medical Devices·42 affected·Oct 17, 2014
High RiskFDA
Mallinckrodt Manufacturing Llc
Tenaxis Medical ArterX(TM) Surgical Sealant, (a) 4mL, REF 9002, and (b) 5mL REF 9006, STERILE R, Store at 2oC - 8oC Adjunct to sutures...
Surgical Devices·246 affected·Oct 17, 2014
High RiskFDA
Biomet Microfixation, Llc
Total Temporomandibular Joint Replacement System- 45mm Lft Narrow Ti Mand
Medical Devices·42 affected·Oct 17, 2014
High RiskFDA
Biomet Microfixation, Llc
Total Temporomandibular Joint Replacement System- 45mm Rt Stand Off TI Mand Reconstruction of the temporomandibular joint
Medical Devices·42 affected·Oct 17, 2014
High RiskFDA
United Natural Trading
Asian 7 Rice Cracker Mix in Bulk 22 lb. cases; Wood Stock Farms Lot # YOUI03 sold to Publix Bakery Plant in Lakeland, FL, and to The Nut...
Bakery & Grains·359 affected·Oct 16, 2014
High RiskFDA
Publix Bakery Plant
Publix Asian Mix, 14 oz. clamshell containers
Food·1,002 affected·Oct 16, 2014
High RiskFDA
United Natural Trading
The Market Basket Asian 7 Rice Cracker Mix Net Wt. 12 oz. (340 g) Distributed by Demondas Supermarkets, Inc. Tewksbury, MA 01876 UPC # ...
Bakery & Grains·76 affected·Oct 16, 2014
High RiskFDA
Pharmaceutical Associates Inc
Cyproheptadine HCl Syrup (Cyproheptadine HCl Oral Solution, USP) 4mg/10 mL, Rx ONLY, Pharmaceutical Associates, Inc., Greenville, SC 2960...
Oral Drugs·9,640 affected·Oct 16, 2014
High RiskFDA
Skeletal Dynamics
Align Radial Stems, Prosthesis, Elbow, Hemi Replacement of the radial head for degenerative or post-traumatic disabilities presenting pa...
Medical Implants·1,700 affected·Oct 16, 2014
High RiskFDA
Diagnostic Hybrids Inc
MicroVue Bb Plus EIA is packaged as a kit which contains all reagent components to perform the test. In vitro diagnostic.
Diagnostic Devices·171 affected·Oct 16, 2014
High RiskFDA
U.b.c Food Distributors, Llc
Mango flavored gelatin mix desert
Food·316 affected·Oct 15, 2014
High RiskFDA
U.b.c Food Distributors, Llc
Strawberry flavored gelatin mix desert
Produce·735 affected·Oct 15, 2014
High RiskFDA
Vision Rt Inc
AlignRT- Intended for prescription use. The system is indicated for use during simulation, setup and stereotactic radiosurgery and preci...
Medical Devices·7 affected·Oct 15, 2014
High RiskFDA
Depuy Orthopaedics, Inc.
ATTUNE Intuition Distal Femoral Jig; sold non-sterile; product is wrapped in bubble wrap and then sealed inside a polyethylene bag
Medical Devices·3,082 affected·Oct 15, 2014
High RiskFDA
American Medical Systems, Inc.
AdVance"Male Sling System, REF 720088-01 & AdVance" XP Male Sling System REF 720163-01 (not commercially available in the US) The A...
Medical Implants·10,085 affected·Oct 15, 2014
High RiskFDA
American Medical Systems, Inc.
AMS Monarc + Subfascial Hammock with Tensioning Suture REF 72404193 and AMS Monarc C Subfascial Hammock with Tensioning Suture REF 724041...
Medical Implants·2,165 affected·Oct 15, 2014
High RiskFDA
Vann Healthcare Services Inc
Tri-mix #4 (Papaverine 30 mg, Phentolamine 1 mg, Prostaglandin-1 10 mcg/mL), packaged in 10 mL sterile glass vials, Rx, Vann Healthcare ...
Drugs·7 affected·Oct 14, 2014
High RiskFDA
Vann Healthcare Services Inc
Hydroxyprogesterone Caproate, 250 mg per mL, 5 mL vial, Rx, Vann Healthcare Pharmacy, 1220 N Race Street, Glasgow, KY 42141
Drugs·1 affected·Oct 14, 2014