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High RiskFDA
Instrumed International, Inc.
Titanium fixation screws, springloaded are used in traction skull tongs for traction used to immobilize a patient with a cervical spine i...
Surgical Devices·22 affected·Sep 8, 2014
High RiskFDA
Plum, Inc.
Plum Organics Little Cremes: Organic Rice Milk Snacks; Super Reds: Pomegranate, Beet and Berry; Net Wt. 1 oz. (28 grams) 8 CT. USDA O...
Dairy·99,623 affected·Sep 5, 2014
High RiskFDA
Publix Super Markets, Inc.
Publix brand Jalapeno Bagels, sold in self service bins and counter sales.
Food·20,520 affected·Sep 5, 2014
High RiskFDA
Wholesome Harvest Baking, Inc.
Frozen jalapeno bagels sold under the Maple Leaf Bakery brand in three different sizes: 3 oz. (64 bagels/case), 4 oz. (78 bagels/case), a...
Frozen Food·342 affected·Sep 5, 2014
High RiskFDA
Plum, Inc.
Plum Organics Little Cremes: Organic Rice Milk Snacks; Super Purples: Acai, Blackberry and Purple Carrot; Net Wt. 1 oz. (28 grams) 8 ...
Dairy·99 affected·Sep 5, 2014
High RiskFDA
Plum, Inc.
Plum Organics Little Cremes: Organic Rice Milk Snacks; Super Greens: Kale, Apple and Sweet Potato; Net Wt. 1 oz. (28 grams) 8 CT. USD...
Dairy·99,623 affected·Sep 5, 2014
High RiskFDA
Iberia Foods Corp.
IBERIA Yellow Rice Spanish Style Enriched Parboiled Rice
Food·660 affected·Sep 4, 2014
High RiskFDA
Hospira Inc.
Bupivacaine HCl Inj., USP, 0.5% (5 mg/mL), 30 mL Single-dose Preservative-Free, For Nerve Block, Caudal, and Epidural Anesthesia, Not for...
Drugs·75,000 affected·Sep 4, 2014
High RiskFDA
Ge Healthcare, Llc
Innova IGS 540 Indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anat...
Diagnostic Devices·10 affected·Sep 4, 2014
High RiskFDA
Ge Healthcare, Llc
Discovery IGS 740 Indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human a...
Diagnostic Devices·1 affected·Sep 4, 2014
High RiskFDA
Teleflex Medical
Aqauapak 728 SW, 760 ML W/028 Adaptor, Intl, Product No. 403728; Aqauapak 1028 SW, 1070 ML/W028 Adaptor, Intl, Product No. 404128; Aqauap...
Medical Devices·3,193,548 affected·Sep 3, 2014
High RiskFDA
Depuy Orthopaedics, Inc.
RECLAIM Distal Reamer Extension Non Sterile REF 2975-00-500 Intended as an attachment device to the distal reamers to allow the sur...
Medical Devices·875 affected·Sep 3, 2014
High RiskFDA
Teleflex Medical
Aquapak Adaptor, 028 NEB, INTL, Product No. 403128; Aquapak Adaptor, 033 NEB, INTL, Product No. 403133; Aqaupak Nebulizer Adaptor 028, S...
Medical Devices·3,193,548 affected·Sep 3, 2014
High RiskFDA
Baxter Healthcare Corp.
SPECTRUM Pump, Model No. 35700BAX. Intended to be used for the controlled administration of intravenous fluids.
Medical Devices·56 affected·Sep 3, 2014
High RiskFDA
Siemens Medical Solutions Usa, Inc
Siemens AXIOM Luminos dRF Max systems The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiog...
Diagnostic Devices·1 affected·Sep 2, 2014
High RiskFDA
Aerogen Ltd.
The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-...
Respiratory Devices·2,421 affected·Sep 2, 2014
High RiskFDA
Siemens Medical Solutions Usa, Inc
Siemens Luminos Agile Max system The Luminos Agile is intended to be used as a universal imaging system for radiographic and fluoroscop...
Medical Devices·5 affected·Sep 2, 2014
High RiskFDA
Siemens Medical Solutions Usa, Inc
Siemens Uroskop Omnia Max system The Uroskop Omnia is a solid state detector fluoroscopic X-Ray system, primarily for urological applic...
Diagnostic Devices·2 affected·Sep 2, 2014
High RiskFDA
Synthes, Inc.
DePuy Synthes TI Vectra Plates: TI Vectra-One" Plate 2 Level / 34 mm part 04.613.184 3337672 TI Vectra" Plate 3 Level / 57 mm ...
Medical Devices·16 affected·Sep 2, 2014
High RiskFDA
Siemens Medical Solutions Usa, Inc
Siemens Ysio Max system The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiog...
Diagnostic Devices·10 affected·Sep 2, 2014
High RiskFDA
Aerogen Ltd.
The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-...
Respiratory Devices·36 affected·Sep 2, 2014
High RiskFDA
Arjo Hospital Equipment Ab
Pressure IQ Evolve Mattress; Non-powered mattress replacement system. Intended for patients with medium to high risk for developing pr...
Medical Devices·1,034 affected·Sep 1, 2014
High RiskFDA
Supreme Distributors, Inc.
Supreme Choice brand Jumbo Lump, 16 oz; Premium Pasteurized Crab Meat. Product of Thailand. Distributed by Supreme Lobster and Seafoo...
Meat & Poultry·0 affected·Aug 30, 2014
High RiskFDA
Supreme Distributors, Inc.
Supreme Choice brand Super Lump, 16 oz; Premium Pasteurized Crab Meat. Product of Thailand. Distributed by Supreme Lobster and Seafoo...
Meat & Poultry·0 affected·Aug 30, 2014
High RiskFDA
Supreme Distributors, Inc.
Supreme Choice brand Colossal, 16 oz; Premium Pasteurized Crab Meat. Product of Thailand. Distributed by Supreme Lobster and Seafood ...
Meat & Poultry·0 affected·Aug 30, 2014
High RiskFDA
Supreme Distributors, Inc.
Supreme Choice brand Backfin, 16 oz; Premium Pasteurized Crab Meat. Product of Thailand. Distributed by Supreme Lobster and Seafood C...
Meat & Poultry·0 affected·Aug 30, 2014
High RiskFDA
Supreme Distributors, Inc.
Supreme brand Colossal Crab Meat, 16 oz; Premium Pasteurized Crab Meat. Product of Thailand. Distributed by Supreme Lobster and Seafo...
Meat & Poultry·0 affected·Aug 30, 2014
High RiskFDA
Supreme Distributors, Inc.
Supreme brand Special Crab Meat, 16 oz; Premium Pasteurized Crab Meat. Product of Thailand. Distributed by Supreme Lobster and Seafoo...
Meat & Poultry·0 affected·Aug 30, 2014
High RiskFDA
Supreme Distributors, Inc.
Blue Star Claw Crab Meat, 16 oz; Premium Pasteurized Crab Meat. Product of Thailand. Distributed by Supreme Lobster and Seafood Compa...
Meat & Poultry·0 affected·Aug 30, 2014
High RiskFDA
Supreme Distributors, Inc.
Sebastian Supreme brand Super Lump Crab Meat, 16 oz; Premium Pasteurized Crab Meat. Product of Thailand. Distributed by Supreme Lobs...
Meat & Poultry·0 affected·Aug 30, 2014
High RiskFDA
Supreme Distributors, Inc.
Supreme Choice brand Special, 16 oz; Premium Pasteurized Crab Meat. Product of Thailand. Distributed by Supreme Lobster and Seafood C...
Meat & Poultry·0 affected·Aug 30, 2014
High RiskFDA
Michael Foods, Inc.
Papetti's Table Ready Refrigerated pre-cooked scrambled eggs. Keep refrigerated 33 - 40 degrees F. Packaged in two different size confi...
Food·46,025 affected·Aug 29, 2014
High RiskFDA
R.m. Palmer Company
soft caramel balls coated in chocolate in orange plastic bag with labeling: palmer Creepy Peepers Chocolaty Coated Soft Caramel Filled E...
Dairy·142 affected·Aug 29, 2014
High RiskFDA
Phoenix Produce & Noodle Company, Llc.
Chinese Style Noodles, 10lbs./bx
Food·1,190 affected·Aug 29, 2014
High RiskFDA
Hostess Brands Llc
Hostess Powdered Single-Serve Donettes, 3 oz., 6 ct.
Food·48,974 affected·Aug 28, 2014
High RiskFDA
Hostess Brands Llc
Hostess Powdered Single-Serve Donettes- FROZEN ONLY, 3 oz., 6 ct.
Frozen Food·3,247 affected·Aug 28, 2014
High RiskFDA
Hostess Brands Llc
Hostess Frosted Bagged Donettes- FROZEN ONLY, 11.25 oz.
Frozen Food·4,102 affected·Aug 28, 2014
High RiskFDA
Hostess Brands Llc
Hostess Powdered Bagged Donettes, 10.5 oz.
Food·17,330 affected·Aug 28, 2014
High RiskFDA
Hostess Brands Llc
Hostess Powdered Bagged Donettes- FROZEN ONLY, 10.5 oz.
Frozen Food·8,664 affected·Aug 28, 2014
High RiskFDA
Hostess Brands Llc
Hostess Frosted Bagged Donettes, 11.25 oz
Food·122,705 affected·Aug 28, 2014
High RiskFDA
Solace International Inc
Dermatend Ultra, mole, wart and skin tag remover, For external use only, Ingredient: Distilled Water, Sanguinaria Canadensis, Vegetable G...
Drugs·1,249 affected·Aug 28, 2014
High RiskFDA
Solace International Inc
Dermatend Original, mole, wart and skin tag remover, For external use only, Ingredient: Distilled Water, Sanguinaria Canadensis, Vegetabl...
Drugs·1,606 affected·Aug 28, 2014
High RiskFDA
Alvogen, Inc
Oxycodone and Acetaminophen Tablets USP 10 mg/325 mg 100 count bottles Rx Only. Manufactured by Norwich Pharmaceuticals Inc., Norwich, N...
Oral Drugs·8,964 affected·Aug 28, 2014
High RiskFDA
Fougera Pharmaceuticals Inc.
FLUOCINONIDE GEL USP, 0.05%, Rx only, For External Use Only, Not For Ophthalmic Use, a) NET WT 15 gram tubes and b) NET WT 60 grams tubes...
Topical Drugs·59,622 affected·Aug 28, 2014
High RiskFDA
Motion Concepts
TRx Vertical Positioner, Classification Name: Wheelchair Component - Power Positioning System.
Medical Devices·59 affected·Aug 28, 2014
High RiskFDA
Merge Healthcare, Inc.
eFilm Workstation 4.0 and 4.0.1. eFilm Workstation is one of the components of a PACS (Picture Archiving and Communications System). ...
Medical Devices·2,630 affected·Aug 28, 2014
High RiskFDA
Vygon Corporation
Bionector Needleless connector. Bionector is a multi-purpose catheter accessory; a closed needle-less system permitting blood sampling, i...
Surgical Devices·42,250 affected·Aug 28, 2014
High RiskFDA
Mondelez Global Llc
Chiclets Gum, 200 - 2 piece packs (400 pieces), Retail UPC 0 12546 02509 6, Case UPC 10012546108499
Food·3,863,888 affected·Aug 27, 2014