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High RiskFDA
Instrumed International, Inc.
An endometrial suction curette is a device used to remove material from the uterus and from the mucosal lining of the uterus by scraping ...
Surgical Devices·26 affected·Sep 8, 2014
High RiskFDA
Instrumed International, Inc.
McKenzie Perforator Drills are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold u...
Surgical Devices·4 affected·Sep 8, 2014
High RiskFDA
Instrumed International, Inc.
Manual bunnell cranial drills are bone cutting and drilling instruments that are used without a power source on a patient's skull sold un...
Medical Devices·13 affected·Sep 8, 2014
High RiskFDA
Instrumed International, Inc.
Gardner-Wells wrenches are used in traction skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fra...
Medical Devices·2 affected·Sep 8, 2014
High RiskFDA
Ortho-clinical Diagnostics
VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), System Product Code 6802445. The VITROS 4600 Chemistry System is in...
Diagnostic Devices·97 affected·Sep 8, 2014
High RiskFDA
Instrumed International, Inc.
Cloward Spanner gauges are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under...
Medical Devices·5 affected·Sep 8, 2014
High RiskFDA
Instrumed International, Inc.
Cushing perforating drills are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold u...
Surgical Devices·9 affected·Sep 8, 2014
High RiskFDA
Instrumed International, Inc.
CVB distraction screws are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under...
Surgical Devices·790 affected·Sep 8, 2014
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