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High RiskFDA
Boston Scientific Corporation
FFR Link-FFR Signal Processing Module, Material Number H7495551000 It is intended to condition physiological signals from measuring devi...
Medical Devices·3 affected·May 15, 2017
High RiskFDA
Sabor Mexicano
Sabor Mexicano Homemade Corn Chips: Packaged in 12 oz. (9 units per case), UPC 8-53094-00417-7, and Fun size 5 oz. ( 12 units per cas...
Snacks & Candy·4,959 affected·May 14, 2017
High RiskFDA
New Punjab Sweets Inc.
New Punjab Sweets, Jalebi
Food·36 affected·May 12, 2017
High RiskFDA
Depuy Mitek, Inc., A Johnson & Johnson Co.
DePuy Mitek LATARJET EXPERIENCE Extraction Driver Product Code: 288216 Product Usage: The Latarjet Cortical Screw set is intended to ...
Medical Devices·115 affected·May 12, 2017
High RiskFDA
Depuy Mitek, Inc., A Johnson & Johnson Co.
DePuy Mitek LATARJET EXPERIENCE Coracoid Drill Product Code: 288201 Product Usage: The Latarjet Cortical Screw set is intended to trea...
Medical Devices·184 affected·May 12, 2017
High RiskFDA
Depuy Mitek, Inc., A Johnson & Johnson Co.
DePuy Mitek LATARJET EXPERIENCE Top Hat Tap Product Code: 288203 Product Usage: The Latarjet Cortical Screw set is intended to treat ...
Medical Devices·153 affected·May 12, 2017
High RiskFDA
Terumo Cardiovascular Systems Corp
Tubing Pack Convenience Kit, Product Code 65217 Product Usage: Intended for use only in the extracorporeal circuit of the cardiopulmo...
Medical Devices·30 affected·May 12, 2017
High RiskFDA
Trident Seafoods Corp - Island Enterprise M/v
Trident Item # 38520, Panko Breaded Alaska Cod, 4 oz. Square Portions Raw, Food Service packages, frozen, Net Wt. 10 lbs.
Bakery & Grains·432 affected·May 11, 2017
High RiskFDA
Trident Seafoods Corp - Island Enterprise M/v
Trident Item # 16596, Alaska Cod Diamond Cut 3 oz, English Style Battered Deep Fry, food service packages, frozen, Net wt. 10 lbs.
Frozen Food·707 affected·May 11, 2017
High RiskFDA
Trident Seafoods Corp - Island Enterprise M/v
Trident Item # 474568, Irregulars Battered Cod 3 oz Battered Diamonds, food service packages, frozen, Net wt. 10 lbs.
Frozen Food·10 affected·May 11, 2017
High RiskFDA
Lyrical Foods Inc
Kite Hill Mushroom and Ricotta Ravioli; frozen Ravioli made with almond milk ricotta: 9 oz. package. UPC 856624004173 Owned and d...
Dairy·1,000 affected·May 11, 2017
High RiskFDA
Trident Seafoods Corp - Island Enterprise M/v
Trident Item # 17116, Alaska Cod Rectangles 3 oz,Crunchy Breaded, food service packages, frozen, Net wt. 10 lbs.
Bakery & Grains·294 affected·May 11, 2017
High RiskFDA
Trident Seafoods Corp - Island Enterprise M/v
Trident Item # 16595, Alaska Cod Squares 4 oz, raw breaded panko, food service packages, frozen, Net wt. 10 lbs.
Bakery & Grains·1,163 affected·May 11, 2017
High RiskFDA
Trident Seafoods Corp - Island Enterprise M/v
Trident Item # 16582, Alaska Cod Rectangles 4 oz, Raw Breaded, food service packages, frozen, Net wt. 10 lbs.
Bakery & Grains·678 affected·May 11, 2017
High RiskFDA
Trident Seafoods Corp - Island Enterprise M/v
Trident Item # 474568, Irregulars Breaded Cod 2 oz. 10 Grain Cod, food service packages, frozen, Net wt. 10 lbs.
Bakery & Grains·7 affected·May 11, 2017
High RiskFDA
Trident Seafoods Corp - Island Enterprise M/v
Trident Item # 421048, Multi-Grain Alaskan Cod, Frozen, RETAIL packages, Net wt. 12 oz. UPC 0 28029 21048 4 The retail label is read i...
Seafood·2,182 affected·May 11, 2017
High RiskFDA
Athome Medical, Inc.
Oxygen Refrigerated Liquid USP UN 1073, Rx only, At Home Medical 200 American Road, Morris Plains, NJ 07950,973-538-0485.
Drugs·80 affected·May 11, 2017
High RiskFDA
Philips Electronics North America Corporation
Philips DigitalDiagnost 3.1.x X-Ray System
Diagnostic Devices·132 affected·May 11, 2017
High RiskFDA
Ge Medical Systems, Llc
Optima MR450 1.5T Product Usage: 1 .5T Brivo MR355 and 1.5T Optima MR360 are whole body magnetic resonance scanners designed to suppo...
Cardiac Devices·68 affected·May 11, 2017
High RiskFDA
Ge Medical Systems, Llc
Optima MR750 3.0T Product Usage: The Optima MR450 1.5T system is a whole body magnetic resonance scanner designed to support high re...
Cardiac Devices·68 affected·May 11, 2017
High RiskFDA
Ge Medical Systems, Llc
Optima MR450w 1.5T Product Usage: The Optima MR450w 1.5T system is a whole body magnetic resonance scanner designed to support high r...
Cardiac Devices·68 affected·May 11, 2017
High RiskFDA
Zimmer Gmbh
Normed General Instruments 503004541: Werber Countersink Cannulated for micro CBS Screws, AO 503004341: Werber Countersink Cannulated fo...
Medical Implants·138 affected·May 11, 2017
High RiskFDA
Becton Dickinson & Co.
BD Phoenix PMIC-107, Catalog Number 448417, UDI #s (01)30382904484171, (10)7031818(17)180228(30)0025, IVD. PMIC-107 is a Gram positive ...
Medical Devices·7,750 affected·May 11, 2017
High RiskFDA
Teleflex Medical
Sheridan SHER-I-SLIP and SOFT-TIP Intubating Stylets are intubating stylets manufactured from galvanized carbon steel and aluminum rods t...
Medical Devices·21,690 affected·May 11, 2017
High RiskFDA
Ge Medical Systems, Llc
1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, Signa Vibrant Product Usage: The 1.5T Signa HDx family and 3.0T Signa HDx family are a ...
Cardiac Devices·68 affected·May 11, 2017
High RiskFDA
Ge Medical Systems, Llc
1.5T Signa HDx, 3.0T Signa HDx, 1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, Signa Vibrant Product Usage: The GE Signa¿ HDx MR system...
Cardiac Devices·68 affected·May 11, 2017
High RiskFDA
Ge Medical Systems, Llc
SIGNA Creator, SIGNA ExplorerProduct Usage: 1.5T SIGNA Creator and 1.5T SIGNA Explorer is a whole body magnetic resonance scanner design...
Cardiac Devices·68 affected·May 11, 2017
High RiskFDA
Zydus Pharmaceuticals Usa Inc
Divalproex Sodium Delayed Release Tablets, USP, 250 mg 100-count bottle (NDC 68382-032-01), b.) 500-count bottle (NDC 68382-032-05),Rx on...
Oral Drugs·115,122 affected·May 10, 2017
High RiskFDA
Zydus Pharmaceuticals Usa Inc
Divalproex Sodium Delayed Release Tablets, USP, 125 mg, 100-count bottle Rx only, Manufactured by Cadila Healthcare Ltd, Ahmedabad, Indi...
Oral Drugs·108,096 affected·May 10, 2017
High RiskFDA
Zydus Pharmaceuticals Usa Inc
Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a.) 100-count bottle (NDC 68382-033-01) b.) 500-count bottle (NDC 68382-033-05), ...
Oral Drugs·108,726 affected·May 10, 2017
High RiskFDA
Medtronic Navigation, Inc.
Install CD, Spine tools, Plus and S7, Version 25. Model Number 9731958.
Medical Devices·108 affected·May 10, 2017
High RiskFDA
Convatec, Inc
Non-Rebreather Oxygen Mask, Adult High Concentration with 2.1 m (7) Oxygen Tubing, Product Code 108MM
Respiratory Devices·0 affected·May 10, 2017
High RiskFDA
Convatec, Inc
Oxygen Masks, Elongated (Under Chin), Adult Med Concentration, No Tubing, FITS-All Conn., Product Code 3104-E
Respiratory Devices·0 affected·May 10, 2017
High RiskFDA
Convatec, Inc
Oxygen Mask, Elongated (Under the Chin) Pediatric, High Concentration Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-All Oxygen Connector...
Respiratory Devices·0 affected·May 10, 2017
High RiskFDA
Convatec, Inc
Non-Rebreathing Mask, Reservoir Bag, Check Valve, One Side Valve, with Tubing, Product Code 106-E, Product Code 3226MM, and Product Code...
Medical Devices·0 affected·May 10, 2017
High RiskFDA
Convatec, Inc
Oxygen Masks, Elongated (Under Chin) Adult High Conc., Non-Rebreather, 7ft O2 Tubing, Check Valve, One Side Valve, FITS-All Conn., Produc...
Respiratory Devices·0 affected·May 10, 2017
High RiskFDA
Convatec, Inc
Oxygen Mask, Standard (Under the Lip) Infant, High Concentration Non-Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-All Oxygen Connector ...
Respiratory Devices·0 affected·May 10, 2017
High RiskFDA
Convatec, Inc
Non-Rebreather Mask, Reservoir Bag, Check Valve, Two Side Valves, No Tubing, Product Code 226MM
Medical Devices·0 affected·May 10, 2017
High RiskFDA
Convatec, Inc
Oxygen Masks, Elongated (under chin), Adult Med Conc., No Tubing, Product Code 104-E;
Respiratory Devices·816,709 affected·May 10, 2017
High RiskFDA
Henning Cheese, Inc.
Henning's Wisconsin Cheese Colby Jack, Colby & Monterey Jack Blended Together. Packaged in 1 lb., 2 lb, and mammoth wheels (A mammoth wh...
Dairy·4,253 affected·May 9, 2017
High RiskFDA
Arrow International Inc
Arrow Pressure Injectable PICC Kit Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days The Arrow Pressure Injectable P...
Surgical Devices·27,485 affected·May 9, 2017
High RiskFDA
Teleflex Medical
Hudson RCI, Pediatric Nasal Cannula, Non-Flared Prongs, Rx only,
Medical Devices·1,150 affected·May 9, 2017
High RiskFDA
Arrow International Inc
1) Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 ...
Surgical Devices·27,485 affected·May 9, 2017
High RiskFDA
Arrow International Inc
Arterial Catheterization Kit, Arterial Line Kit with Sharps Safety Features wire, guide, catheter The Arrow Arterial Catheterization ...
Surgical Devices·27 affected·May 9, 2017
High RiskFDA
Arrow International Inc
1) Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology The Pressure Injectable PICC with Chlorag+ard Antimicrobial and ...
Medical Devices·27,485 affected·May 9, 2017
High RiskFDA
Arrow International Inc
1) Pressure Injectable Multi-Lumen Central Venous Catheterization Kit 2) Pressure Injectable Multi-Lumen Central Venous Catheterization ...
Surgical Devices·27,485 affected·May 9, 2017
High RiskFDA
Beckman Coulter Inc.
Access System-GI Monitor (CA19-9), A83873D, Catalog No. 387687
Medical Devices·249,597 affected·May 9, 2017
High RiskFDA
Arrow International Inc
Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features. The mu...
Surgical Devices·27,485 affected·May 9, 2017