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High RiskFDA
Azer Scientific, Inc.
Fruit Punch Glucose, 100 Gram Concentration, Liquid, 4/Pack of 6 Bottles, 24/cs Accessory to an In Vitro Diagnostic Oral Glucose Tolera...
Diabetes Devices·1,141 affected·Aug 24, 2016
High RiskFDA
Integra Lifesciences Corp.
Integral Lumbar Drainage Set, REF 910420, Sterile EO, Rx only, primary packaged in a PVC blister sealed with Tyvek sheet and secondary pa...
Surgical Devices·18 affected·Aug 23, 2016
High RiskFDA
Integra Lifesciences Corp.
Integra Ventricular Catheter Accessory Kit, REF 951303, Sterile EO, Rx only, packaged in a PVC tray, then secondary package in to Tyvek p...
Surgical Devices·14 affected·Aug 23, 2016
High RiskFDA
Integra Lifesciences Corp.
Integra Drainage Accessory Kits, REF 910122, Sterile EO, Rx only, packaged in one Tyvek pouch. Five (5) sealed Tyvek pouches are packaged...
Medical Devices·1 affected·Aug 23, 2016
High RiskFDA
Integra Lifesciences Corp.
Integra Straight Ventricular Catheter F8, 25 cm, Sterile EO, Rx only, packaged in a Tyvek pouch and secondary packaged in to Tyvek pouch,...
Surgical Devices·10 affected·Aug 23, 2016
High RiskFDA
Integra Lifesciences Corp.
CUSA Dissectron Fingertip Laparoscopic Cannula, REF F75221, Sterile EO, Rx only, packaged in a Tyvek pouch and secondary packaged in Tyve...
Medical Devices·9 affected·Aug 23, 2016
High RiskFDA
Noven Pharmaceuticals, Inc.
Daytrana (methylphenidate transdermal system) Transdermal Patch, 20 mg over 9 hours (2.2 mg/hr), packaged in 30-count patches per box, Rx...
Topical Drugs·364,830 affected·Aug 22, 2016
High RiskFDA
Noven Pharmaceuticals, Inc.
Daytrana (methylphenidate transdermal system) Transdermal Patch, 30 mg over 9 hours (3.3 mg/hr), packaged in 30-count patches per box, Rx...
Topical Drugs·357,420 affected·Aug 22, 2016
High RiskFDA
Noven Pharmaceuticals, Inc.
Daytrana (methylphenidate transdermal system) Transdermal Patch, 10 mg over 9 hours (1.1mg/hr), packaged in- 30 count per box, Rx only, M...
Topical Drugs·1,068,600 affected·Aug 22, 2016
High RiskFDA
Ekos Corporation
The EKOS cart has the catalog number 700-60101. The EKOS cart is a custom infusion stand/cart used to hold and transport the EkoSonic ...
Medical Devices·455 affected·Aug 22, 2016
High RiskFDA
Inland Seafood, Inc.
Inland Market, Maryland Crab Cake, Net Wt. 5 lbs, Inland Market, 1667 Lewis Way, Stone Mountain, GA 30083, for Whole Foods Market
Seafood·86 affected·Aug 19, 2016
High RiskFDA
Inland Seafood, Inc.
Reduced Fat Seafood Cheese Spread, Net Wt. 7 oz. (198 g.), for Publix
Dairy·1,157 affected·Aug 19, 2016
High RiskFDA
Inland Seafood, Inc.
Original Seafood Cheese Spread, Net Wt. 7 oz. (198 g.), for Publix
Dairy·1,324 affected·Aug 19, 2016
High RiskFDA
Inland Seafood, Inc.
Spinach Krab & Artichoke Dip, 12 x 8 oz., for Whole Foods Market.
Produce·35 affected·Aug 19, 2016
High RiskFDA
Inland Seafood, Inc.
Alaskan Salmon Salad, 12 x 8 oz. and 5 lb., for Whole Foods Market
Seafood·218 affected·Aug 19, 2016
High RiskFDA
Inland Seafood, Inc.
Inland Market, Premium Blue Crab Spread, Net Wt. 7 oz. (198 g.) and 16 oz. (454g), Inland Market, 1667 Lewis Way, Stone Mountain, GA 30083.
Seafood·2,880 affected·Aug 19, 2016
High RiskFDA
Inland Seafood, Inc.
Inland Market, Dungeness Crab Cake, Net Wt. 5 lbs, Inland Market, 1667 Lewis Way, Stone Mountain, GA 30083, for Whole Foods Market
Seafood·54 affected·Aug 19, 2016
High RiskFDA
Inland Seafood, Inc.
Smoked Whitefish Salad, 12 x 8 oz., for Whole Foods Market.
Seafood·18 affected·Aug 19, 2016
High RiskFDA
Inland Seafood, Inc.
Spicy Crab Dip, 12 x 8 oz., for Whole Foods Market.
Seafood·27 affected·Aug 19, 2016
High RiskFDA
Inland Seafood, Inc.
Inland Market, Traditional Crab Cake, Net Wt. 5 lbs, Inland Market, 1667 Lewis Way, Stone Mountain, GA 30083, for Whole Foods Market
Seafood·46 affected·Aug 19, 2016
High RiskFDA
Brathwaites Oliver Medical
The Introes Pocket Bougie is an endotracheal tube introducer. The device is an endotracheal tube introducer and it is used as a guide dur...
Medical Devices·760 affected·Aug 19, 2016
High RiskFDA
Panoramic Rental Corp.
Panoramic X-ray Model PC-1000, Laser-1000 packed in a crate Product Usage: The PC-1000 will enable the user to take panoramic x-ray i...
Medical Devices·13,340 affected·Aug 19, 2016
High RiskFDA
Cambridge Farms Of Hanover Llc D
Best Valu Cut/Cortado; Yellow Corn; Maiz Amarillo; Net Wt 14 OZ; Code: SSFF/R 10308; Best By: 04/11/18; Product of Canada; Distributed...
Produce·2,648 affected·Aug 18, 2016
High RiskFDA
Cambridge Farms Of Hanover Llc D
Laura Lynn Vegetable Gumbo Mix; Ingle's Markets Inc./Asheville, NC 28816, 16 oz. pkgs, BB 05/06/18
Produce·300 affected·Aug 18, 2016
High RiskFDA
Cambridge Farms Of Hanover Llc D
The Perfect Bite Co Hawaiian Style Rice & Vegetable Blend, 4 - 12 OZ Bags, Net Weight 3 LBS., Distributed by: TPBC, Glendale, CA 91203; B...
Produce·253 affected·Aug 18, 2016
High RiskFDA
Cambridge Farms Of Hanover Llc D
Key Foods Soup Mix Vegetables, Key Foods Stores/ Staten Island, NY 10314; 16 oz. pkgs; BB 05/02/18; Laura Lynn Vegetable Soup Mix, Ingl...
Produce·1,050 affected·Aug 18, 2016
High RiskFDA
Cambridge Farms Of Hanover Llc D
Better Value Mix Vegetables, Federated Group, Inc./Arlington Heights, IL 60005-1096; 14 oz. pkgs; BB 05/06/18; Morning Fresh Farms Mix ...
Produce·3,051 affected·Aug 18, 2016
High RiskFDA
Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics Universal Acetabular Cup Positioner/Impactor, REF 2101-0200, Non-Sterile, Howmedica Osteonics Corp., Mahwah, NJ, US...
Medical Devices·3,768 affected·Aug 18, 2016
High RiskFDA
Elekta, Inc.
HexaPOD evo RT System Product Usage: The intended use of the device is the control of accurate patient positioning with assistance of...
Medical Devices·13 affected·Aug 18, 2016
High RiskFDA
Elekta, Inc.
Monaco RTP System Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Medical Devices·3,012 affected·Aug 18, 2016
High RiskFDA
Iq Formulations, Llc
E.S.P. Pre-Workout, Energy Stimulant Pre-workout, Powder, 300 g, blue raspberry flavor (UPC 764779-410728.
Produce·34,100 affected·Aug 16, 2016
High RiskFDA
Iq Formulations, Llc
E.S.P. Pre-Workout, Energy Stimulant Pre-workout, Powder, 300 g, fruit punch flavor (UPC 764779-420734), fruit punch (UPC 764779-430740)....
Produce·26,651 affected·Aug 16, 2016
High RiskFDA
Baptista's Bakery, Inc
Snack Factory , Pretzel Crisps Original, UPC 049508006008, 7.2 oz (204g).
Snacks & Candy·281,880 affected·Aug 16, 2016
High RiskFDA
Iq Formulations, Llc
P.S.P., Pre-Workout, Physique Stimulating Pre-workout, Powder, 360 g, fruit punch (UPC 764779-360238). Brand: Metabolic Nutrition.
Produce·1,405 affected·Aug 16, 2016
High RiskFDA
Iq Formulations, Llc
E.S.P. Pre-Workout, Energy Stimulant Pre-workout, Powder, 300 g, green apple (UPC 764779-430740). Brand: Metabolic Nutrition.
Food·25,273 affected·Aug 16, 2016
High RiskFDA
Iq Formulations, Llc
E.S.P. Pre-Workout, Energy Stimulant Pre-workout, Powder, 300 g, Watermelon flavor (UPC 764779-4407566). Brand: Metabolic Nutrition.
Beverages·27,353 affected·Aug 16, 2016
High RiskFDA
Iq Formulations, Llc
P.S.P., Pre-Workout, Physique Stimulating Pre-workout, Powder, 360 g, watermelon flavor (UPC 764779-360450). Brand: Metabolic Nutrition
Beverages·1,403 affected·Aug 16, 2016
High RiskFDA
Iq Formulations, Llc
P.S.P., Pre-Workout, Physique Stimulating Pre-workout, Powder, 360 g, green apple (UPC 764779-360344). Brand: Metabolic Nutrition.
Food·1,384 affected·Aug 16, 2016
High RiskFDA
Baptista's Bakery, Inc
Snack Factory, Pretzel Crisps Srircha Lime, UPC 049508006060, 7.2 oz(204g).
Snacks & Candy·58,320 affected·Aug 16, 2016
High RiskFDA
Iq Formulations, Llc
SYNEDREX, Powerful stimulant weight loss solution, 45 capsules (UPC 764779-224592). Brand: Metabolic Nutrition.
Food·67,113 affected·Aug 16, 2016
High RiskFDA
Zimmer Biomet, Inc.
Coonrad/ Morrey Elbow Pin/ Bushing Replacement size Kit Extra Small. This product is sold sterile. The parts are placed into an inner cav...
Medical Implants·25 affected·Aug 16, 2016
High RiskFDA
Lsi Medience Corporation
Pathfast D-Dimer, Reference number: PF1051-KUS
Medical Devices·42 affected·Aug 16, 2016
High RiskFDA
Hospira Inc.
DOBUTamine Injection, USP 250 mg/20 mL, 20 mL Vial, For IV Use Only, Must be Diluted Prior to Use, (12.5 mg per mL), Rx Only, Hospira, In...
Injectable Drugs·24,000 affected·Aug 15, 2016
High RiskFDA
Prismatik Dentalcraft, Inc
BruxZir Shaded, Model No. 70-1167-NOW0001, 70-1167-NOW0002, 70-1167-NOW0003, 70-1167-NOW0005, 70-1167-NOW0006 The device is indicated...
Medical Devices·150 affected·Aug 15, 2016
High RiskFDA
Pentax Of America Inc
Pentax Video Gastroscope is intended to be used with a Pentax video processor (including light source), documentation equipment, monitor,...
Surgical Devices·3,436 affected·Aug 15, 2016
High RiskFDA
Pentax Of America Inc
Pentax Video Colonoscope is intended to be used with a PENTAX video processor (including light source), documentation equipment, Monitor,...
Surgical Devices·5,090 affected·Aug 15, 2016
High RiskFDA
Microgenics Corporation
Thermo Scientific QMS Everolimus Assay; Model number: 0380000 (US Distribution); 0373852 (Foreign Distribution) Product Usage: The...
Diagnostic Devices·163 affected·Aug 15, 2016
High RiskFDA
Biosense Webster, Inc.
CARTO 3 EP Navigation System and Accessories, Product Codes: FG540000 and FG540000C, Software Versions: v 3.2 , v 4.3 and v 2.3. The CA...
Cardiac Devices·338 affected·Aug 15, 2016