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High RiskFDA
Globalmed Logistix
Lipogems SPA Aspiration Cannulae, intended for aspiration of adipose tissue. LGC 13G (13G x 185mm), Sterile.
Medical Devices·118 affected·Dec 15, 2015
High RiskFDA
Ge Medical Systems, Llc
GE Healthcare, Aestiva 7900, 1006-9305-000. This version of the Datex-Ohmeda 7900 ventilator is used in Datex-Ohmeda Aestiva/5 anesthesi...
Respiratory Devices·2 affected·Dec 15, 2015
High RiskFDA
Bd Diagnostic
BD Viper LT software, version 3.00H
Medical Devices·2 affected·Dec 14, 2015
High RiskFDA
Benlan, Inc.
MED-RX Single Use REF 54-3680R, 8 FR. x 36" (91CM) Polyurethane Feeding Tube For Pediatric Use with Orange Radiopaque Stripe and Enteral ...
Medical Devices·120 affected·Dec 11, 2015
High RiskFDA
A.r.food Brokerage Corp.
Label reading in part: "ECONO***Gandules Verde***Hervidos en Agua y Sal*** Green Pigeon Peas***PREMIUM***NET WT. 15 oz (425g)***PRODUCTO ...
Food·4,052 affected·Dec 10, 2015
High RiskFDA
Boston Scientific Corporation
Boston Scientific, MRI PROPONENT" SR , REF L210 Pacemaker. These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing ...
Cardiac Devices·5 affected·Dec 10, 2015
High RiskFDA
Ascom Us, Inc.
Ascom Mobile Monitoring Gateway (versions 4.1.1 and 4.2.0) and Ascom Unite Connect for Nurse Call (version 2.2.0).
Medical Devices·319 affected·Dec 10, 2015
High RiskFDA
Iba Dosimetry Gmbh
IBA Dosimetry GmbH Lift Table Type 4320, Catalog HA03-010#2 and HA03-000#2
Medical Devices·0 affected·Dec 10, 2015
High RiskFDA
Nestle Waters North America
Sweet Leaf Organic Raspberry Iced Tea, 16 oz glass bottle UPC: 6-51538-06703-6
Beverages·13,175 affected·Dec 9, 2015
High RiskFDA
Nestle Waters North America
Sweet Leaf Organic Original Sweet Tea, 16 oz glass bottle UPC: 6-51538-06700-5
Beverages·35,821 affected·Dec 9, 2015
High RiskFDA
Nestle Waters North America
Sweet Leaf Organic Half and Half Lemonade Tea, 16 oz glass bottle UPC: 6-51538-06708-1
Beverages·15,764 affected·Dec 9, 2015
High RiskFDA
Nestle Waters North America
Sweet Leaf All Natural Citrus Green Tea, 16 oz glass bottle UPC: 6-51538-06720-3
Beverages·0 affected·Dec 9, 2015
High RiskFDA
Nestle Waters North America
Sweet Leaf Organic Tea Mint & Honey, 16 oz glass bottle UPC: 6-51538-06701-2
Beverages·33,916 affected·Dec 9, 2015
High RiskFDA
Eaton Farm Confectionaries, Inc.
Peanut Butter Lust Bar, Net weight 2 ounces, UPC: 1425361001
Dairy·800 affected·Dec 9, 2015
High RiskFDA
Nestle Waters North America
Sweet Leaf All Natural Peach Iced Tea , 16 oz glass bottle UPC: 6-51538-06704-3
Beverages·22,663 affected·Dec 9, 2015
High RiskFDA
Elekta, Inc.
MOSAIQ Oncology Information System MOSAIQ is an oncology information system used to manage workflows for treatment planning and delive...
Medical Devices·399 affected·Dec 9, 2015
High RiskFDA
Zimmer Biomet, Inc.
Zimmer Periarticular Locking Plate System 3.5mm Locking Screw 58 mm Length; Zimmer Periarticular Locking Plate System 2.4mm Locking Scre...
Medical Devices·400 affected·Dec 9, 2015
High RiskFDA
Zimmer Biomet, Inc.
Zimmer Universal Locking System 3.5mm Locking Reconstruction Plate Straight 11 Holes 144mm Length Zimmer Universal Locking System 3.5mm...
Medical Devices·52 affected·Dec 9, 2015
High RiskFDA
Vern's & Son Food Service Distributing
Great Pacific Bagel & Cream Cheese, product is wrapped with flexible clear plastic, net weight 4.5 oz. The UPC is UPC 92438 00300
Dairy·75 affected·Dec 8, 2015
High RiskFDA
Nuovo Pasta Productions, Ltd
Simply Enjoy Shrimp and Lobster Ravioli, 9 oz, refrigerated packaged in plastic tray. Distributed by Foodhold USA, Landover, MD. UPC Cod...
Seafood·129 affected·Dec 8, 2015
High RiskFDA
Encore Medical, Lp
AltiVate Reverse Humeral Broach, Size 10 Catalog number 804-06-040, Size 14 Catalog number 804-06-044, and Size 16 Catalog number 804-06-...
Medical Implants·23 affected·Dec 8, 2015
High RiskFDA
Synthes (usa) Products Llc
SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 ...
Medical Devices·378 affected·Dec 8, 2015
High RiskFDA
Synthes (usa) Products Llc
SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 ...
Medical Devices·289 affected·Dec 8, 2015
High RiskFDA
Synthes (usa) Products Llc
SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 ...
Medical Devices·200 affected·Dec 8, 2015
High RiskFDA
Perkinelmer
Perkin Elmer WIZARD2 10-detector, 550 samples Product Code: 2470-0100, 3470-0100. The Wizard gamma counter is intended to detect and cou...
Medical Devices·47 affected·Dec 8, 2015
High RiskFDA
True North Salmon
True North Gutted Farmed Whole Atlantic Salmon, various weights from 8 to more than 16 lbs. packaged in plastic in styrofoam container,...
Seafood·21,180 affected·Dec 7, 2015
High RiskFDA
Innovasis, Inc
Excella II Rod Cat. No.: SR 55100 5.5 x 100 mm LOT 1502 and Excella II Rod Cat. No.: SR 55110 5.5 x 110 mm LOT 1502 Packaged in heat-s...
Medical Implants·17 affected·Dec 7, 2015
High RiskFDA
Albertsons Llc
Dockside Classics 4 Gourmet Lobster Cakes Net Wt. 12 oz. UPC: 045425167143
Seafood·29 affected·Dec 5, 2015
High RiskFDA
Sunco & Frenchie Llc.
Sunbest Natural Lemon Juice 33.5 Fl. Oz. Distributed by Sunco & Frenchie LLC Clifton, NJ 07011 UPC 089625403007
Beverages·1,736 affected·Dec 4, 2015
High RiskFDA
Synaptive Medical, Inc.
Synaptive Medical BrightMatter Navigator System (Guide System). Part number SYN-0026. The Guide system is comprised of a cart labelled S...
Surgical Devices·8 affected·Dec 4, 2015
High RiskFDA
Compview Medical, Llc
Model NuCARTGN. The NuCART is a mobile display and image management platform used in Minimally Invasive Surgery (MIS) environments to fa...
Medical Devices·10 affected·Dec 4, 2015
High RiskFDA
Steris Corporation
Quick Connects. Steris Corporation. Model numbers: QKC1736E, QKC1736INT, QKC1737E, and QKC1737INT. Each Quick Connect contains a flow un...
Medical Devices·809 affected·Dec 4, 2015
High RiskFDA
Whole Foods Market
Whole Foods Market Tart Key Lime Square Net wt 16 oz. Whole Foods, Emeryville, CA. UPC - 0022263800000
Food·1 affected·Dec 3, 2015
High RiskFDA
Whole Foods Market
Whole Foods Market Crazy for Cream cheese Brownie; Sold as single (4 oz.) and 4-pack (15 oz.) Ingredients: unbleached wheat flour, c...
Dairy·19 affected·Dec 3, 2015
High RiskFDA
Whole Foods Market
Whole Foods Market Salted Caramel Swirl Brownie; Sold in 4-pack (15 oz.) Ingredients: cane sugar, cage free eggs, expeller pressed c...
Dairy·50 affected·Dec 3, 2015
High RiskFDA
Whole Foods Market
Whole Foods Market Brownie Double Trouble; Sold as single (2 oz.) and 4-pack (15 oz.) Ingredients: unbleached wheat flour, sugar, b...
Dairy·31 affected·Dec 3, 2015
High RiskFDA
Whole Foods Market
Whole Foods Market Brownie Choc Full O' Nuts; Sold as single (2 oz.) and 4-pack (15 oz.) Ingredients: unbleached wheat flour, sugar...
Dairy·24 affected·Dec 3, 2015
High RiskFDA
Jody's Gourmet Popcorn
Jody's Gourmet Popcorn, Fabulous Fudge Chocolate Walnut, net weight 8 oz. , one unit per package, packed in clear clamshell, expiration...
Snacks & Candy·215 affected·Dec 3, 2015
High RiskFDA
Whole Foods Market
Whole Foods Market Raspberry Brownie; sold as a single item (2. oz.) or a 4 pack (15 oz.); Ingredients: Unbleached wheat flour, suga...
Dairy·5 affected·Dec 3, 2015
High RiskFDA
Whole Foods Market
Whole Foods Market Peanut Butter & Yah Brownie; Sold as Single- 3. oz and 4 pack 15 oz;. Ingredients: Ingredients: Cane sugar, cage...
Dairy·10 affected·Dec 3, 2015
High RiskFDA
Glaxosmithkline, Llc
Ventolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 200 Metered Inhalations, Rx Only, For Oral Inhalation Only, N...
Oral Drugs·128,704 affected·Dec 3, 2015
High RiskFDA
Becton Dickinson & Company
BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 3.0 mL (Lavender) BD Hemogard Additive: K2EDTA (spray dried), 5.4mg Sterile IVD...
Medical Devices·29,815,600 affected·Dec 3, 2015
High RiskFDA
Zimmer Manufacturing B.v.
NexGEN System REF 5980-37-01 Tibial Component Size Stemmed 3 Precoat, and REF 5986-37-01 Nonaugmentable Tibial Component Option CR/PS/L...
Medical Implants·384 affected·Dec 3, 2015
High RiskFDA
Becton Dickinson & Company
BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 4.0 mL (Lavender) BD Hemogard Additive: K2EDTA (spray dried), 7.2mg Sterile IVD...
Medical Devices·29,815,600 affected·Dec 3, 2015
High RiskFDA
Teleflex Medical
Servo Humidifier 163, Model 01-06-8125-8, REF 6419365 Product Usage: A heat and moisture condenser (artifical nose) is a device inten...
Surgical Devices·2,700 affected·Dec 3, 2015
High RiskFDA
Ethicon, Inc.
Gynecare Thermachoice III Uterine Balloon Therapy System Ethicon, Inc. The GYNECARE THERMACHOICE¿ III Uterine Balloon Therapy (UBT) Sy...
Medical Devices·96,124 affected·Dec 3, 2015
High RiskFDA
Teleflex Medical
MAQUET Servo Humidifier 163, Inmed Mfg. Sdn. Bhd. Lot PT 2577, Jalan Perusahaan, 4, 34600 Kamunting, Perak, Malaysia.
Medical Devices·2,700 affected·Dec 3, 2015
High RiskFDA
Becton Dickinson & Company
BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 2.0 mL (Pink) BD Hemogard Additive: K2EDTA (spray dried), 3.6mg Sterile IVD BD,...
Medical Devices·29,815,600 affected·Dec 3, 2015