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High RiskFDA
Organ Recovery Systems, Inc.
SPS-1, Static Preservation Solution [1 or 2 liter bags], Sterile; Organ Recovery Systems, One Pierce Place, Itasca, IL 60143
Medical Devices·4,806 affected·Dec 14, 2016
High RiskFDA
Medline Industries Inc
14 mm Distraction Pin, Exagg Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distraction P...
Medical Devices·1,031 affected·Dec 14, 2016
High RiskFDA
Medline Industries Inc
16 mm Distraction Pin, Titanium, Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distracti...
Medical Devices·198 affected·Dec 14, 2016
High RiskFDA
Medline Industries Inc
12 mm Distraction Pin, Blunt Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distraction P...
Medical Devices·300 affected·Dec 14, 2016
High RiskFDA
Medline Industries Inc
16 mm [or 18 mm] Distraction Pin, Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distract...
Medical Devices·2,112 affected·Dec 14, 2016
High RiskFDA
Williams-sonoma
Williams-Sonoma Meyer Lemon Poppy Quick bread mix, NET WT. 1 LB. 2 OZ (509 g)
Bakery & Grains·1,220 affected·Dec 13, 2016
High RiskFDA
Arro Corporation
50423 Madison Hot Cocoa WIP; Production date 11/30/16
Food·35,394 affected·Dec 13, 2016
High RiskFDA
Arro Corporation
Hot Cocoa, NOT FOR RETAIL SALE, Prod: 28OCT2016, BB: 28JUN2017, Net Weight: 907 g (2.0 lb), Best Before: 28JUN2017
Food·46 affected·Dec 13, 2016
High RiskFDA
Arro Corporation
Caramel Apple Cake Mix (590g)
Bakery & Grains·15,764 affected·Dec 13, 2016
High RiskFDA
Siemens Medical Solutions Usa Inc.
Bio mCT-S(40) 3R->4R Upgrade, Material Number 10250743 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Comput...
Diagnostic Devices·1 affected·Dec 13, 2016
High RiskFDA
Siemens Medical Solutions Usa Inc.
Biograph mCT-X w/TrueV Upgrade, Material Number 10250745 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Comp...
Diagnostic Devices·1 affected·Dec 13, 2016
High RiskFDA
Ion Beam Applications S.a.
Proteus 235, Proton Therapy System Product Usage: The Proton Therapy System - Proteus 235 is a medical device designed to produce and...
Medical Devices·6 affected·Dec 13, 2016
High RiskFDA
Siemens Medical Solutions Usa Inc.
Biograph mCT S(40)-4R, Material Number 10248671 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomo...
Diagnostic Devices·88 affected·Dec 13, 2016
High RiskFDA
Siemens Medical Solutions Usa Inc.
Biograph mCT S(64)-4R, Material Number 10248672 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomo...
Diagnostic Devices·102 affected·Dec 13, 2016
High RiskFDA
Boston Scientific Corporation
Boston Scientific Imager II Angiographic Catheter, M001316581 (5-pack outer package UPN), M001316580, single unit, inner package UPN)
Surgical Devices·26 affected·Dec 13, 2016
High RiskFDA
Siemens Medical Solutions Usa Inc.
Biograph mCT S(64)-3R, Material Number 10248669 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomo...
Diagnostic Devices·34 affected·Dec 13, 2016
High RiskFDA
Siemens Medical Solutions Usa Inc.
Biograph mCT X-3R, Material Number 10248673 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomograp...
Diagnostic Devices·18 affected·Dec 13, 2016
High RiskFDA
Siemens Medical Solutions Usa Inc.
BIOGRAPH mCT 20 Excel, Material Number 10507786 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomo...
Diagnostic Devices·51 affected·Dec 13, 2016
High RiskFDA
Siemens Medical Solutions Usa Inc.
Biograph mCT Flow 40-4R, Material Number 10529159 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed To...
Diagnostic Devices·1 affected·Dec 13, 2016
High RiskFDA
Siemens Medical Solutions Usa Inc.
Biograph mCT S(40)-3R, Material Number 10248668 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomo...
Diagnostic Devices·41 affected·Dec 13, 2016
High RiskFDA
On-x Life Technologies, Inc.
Chord-X Chordal Sizer is designed to assist in determining the proper length of chordal replacement prostheses to repair the mitral valve...
Medical Implants·45 affected·Dec 13, 2016
High RiskFDA
Chocolate Holdings Inc. Dba Charles Chocolates
Charles Chocolates Toffee Chocolate Macadamia; NET WT. 6.2 oz .(180 grams) UPC: 8 59033 00440 6 Charles Chocolates, San Francisco, CA
Snacks & Candy·4 affected·Dec 12, 2016
High RiskFDA
New Hope Mills Mfg., Inc.
NEW HOPE MILLS Crepe MIX, NET WT. 1 LB. 4 OZ, UPC 074703601529 --- 181 York Street, Auburn, New York 13021 ---Product is packaged in a br...
Food·2,688 affected·Dec 12, 2016
High RiskFDA
Amneal Pharmaceuticals Llc
Rabeprazole Sodium Delayed Release Tablets, 20 mg, a) 30-count bottle (NDC 65162-0724-03), b) 90-count bottle (NDC 65162-0724-09), Rx Onl...
Oral Drugs·105,215 affected·Dec 12, 2016
High RiskFDA
Implant Direct Sybron Manufacturing, Llc
SwishTapered Implant
Medical Implants·17 affected·Dec 12, 2016
High RiskFDA
Medtronic Navigation, Inc.
AxIEM Touch N Go Pointer Probe. Model Number: 9735318. Placed in a 30mil PETG tray sealed with a Tyvek lid and then placed in a shelf car...
Medical Devices·111 affected·Dec 12, 2016
High RiskFDA
Great Basin Scientific, Inc.
Great Basin Staph lD/R Blood Culture Panel The Great Basin Staph lD/R Blood Culture Panel is a qualitative, multiplex in vitro diagnos...
Diagnostic Devices·32 affected·Dec 12, 2016
High RiskFDA
Medline Ind
Medline E-Z Lubricating Jelly; Bacteriostatic. Water Soluble. Sterile. 2 FL OZ (59 ml). Product Usage: For medical purposes to lubri...
Diagnostic Devices·12,024 affected·Dec 12, 2016
High RiskFDA
Olympus Corporation Of The Americas
Uretero-reno videoscope URF-V2 and URF-V2R endoscope and accessories The URF-V2/V2R endoscopes are intended for use in endoscopic diag...
Medical Devices·1,627 affected·Dec 12, 2016
High RiskFDA
Olympus Corporation Of The Americas
URF-P6 Uretero-reno fiberscope and URF-P6R Uretero-reno fiberscope
Medical Devices·3,461 affected·Dec 12, 2016
High RiskFDA
Real Fudge
Coconut Fudge, brand Real Fudge. Product is sold in clear plastic deli container in 8 oz.
Food·22 affected·Dec 11, 2016
High RiskFDA
Real Fudge
Plain Fudge, brand Real Fudge. Product is sold in clear plastic deli container in 8, 12,16, and 24 oz.
Food·290 affected·Dec 11, 2016
High RiskFDA
Real Fudge
White Fudge Oreo, brand Real Fudge. Product is sold in clear plastic deli container in 8 oz. and 16 oz.
Food·65 affected·Dec 11, 2016
High RiskFDA
Real Fudge
White Fudge, brand Real Fudge. Product is sold in clear plastic deli container in 8 oz.
Food·16 affected·Dec 11, 2016
High RiskFDA
Real Fudge
Rocky Road Fudge, brand Real Fudge. Product is sold in clear plastic deli container in 8, 12, and 16 oz.
Food·59 affected·Dec 11, 2016
High RiskFDA
Real Fudge
Peanut Butter Fudge, brand Real Fudge. Product is sold in clear plastic deli container in 8, 12, and 16 oz.
Dairy·78 affected·Dec 11, 2016
High RiskFDA
Real Fudge
Salted Caramel Fudge, brand Real Fudge. Product is sold in clear plastic deli container in 8, 16, and 24 oz.
Food·73 affected·Dec 11, 2016
High RiskFDA
Real Fudge
Nutty fudge, brand Real Fudge. Product is sold in clear plastic deli container in 8, 12,16, and 24 oz.
Food·261 affected·Dec 11, 2016
High RiskFDA
Real Fudge
Dark Chocolate Fudge, brand Real Fudge. Product is sold in clear plastic deli container in 8, 16, and 24 oz.
Snacks & Candy·82 affected·Dec 11, 2016
High RiskFDA
Sweets & Desserts, Inc.
The Sweet Dessert Corp., Cheesecake Cherry, Peso Neto (Net Weight) 3oz and 4 oz., Carr. 173 Km 7.1 Bo. Sumidero, Aguas Buenas, P.R. 00703
Dairy·384 affected·Dec 9, 2016
High RiskFDA
Eby Brown Co
TURKEY & CHEESE SANDWICH Net Wt 4,7 oz (133g) Savory turkey & cheese on wheat bread KEEP REFRIGERATED UPC 6 42984 67592 0
Dairy·4,987 affected·Dec 9, 2016
High RiskFDA
Eby Brown Co
TUNA SALAD SANDWICH Net Wt 4.5 oz (128g) Creamy tuna salad on wheat bread KEEP REFRIGERATED UPC 6 42984 67588 3
Seafood·3,544 affected·Dec 9, 2016
High RiskFDA
Sweets & Desserts, Inc.
The Sweet Dessert Corp., Cheesecake Parcha (Passion Fruit), Peso Neto (Net Weight) 3oz and 4 oz., Carr. 173 Km 7.1 Bo. Sumidero, Aguas Bu...
Dairy·550 affected·Dec 9, 2016
High RiskFDA
Sweets & Desserts, Inc.
The Sweet Dessert Corp., Tres Leches Chocolate (Three Milk Cake with chocolate), Peso Neto (Net Weight) 3oz and 4 oz., Carr. 173 Km 7.1 B...
Dairy·200 affected·Dec 9, 2016
High RiskFDA
Dorothy Dawson Food Products Dba Dawson Foods
Dawson Foods Inc. Creamy White Frosting Mix , 5 Lb Bags, 6 5Lb bags per case Creamy White, Ambient Storage
Food·138 affected·Dec 9, 2016
High RiskFDA
Sweets & Desserts, Inc.
The Sweet Dessert Corp., Cheesecake Fresa (Strawberry), Peso Neto (Net Weight) 3 oz and 4 oz (small labels)3 and 4oz (large label), Carr....
Dairy·2,000 affected·Dec 9, 2016
High RiskFDA
Dawn Food Products Inc.
SHEILA G'S EGGLESS BROWNIE BRITTLE MIX Item 02403038 50 lb bag
Food·624 affected·Dec 9, 2016
High RiskFDA
O'pelle Enterprises, Inc.
Opelle Bakery Egg Bagel (B-105), case of 96 (4 oz.), Frozen Raw.
Frozen Food·101 affected·Dec 9, 2016