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High RiskFDA
Giant Eagle, Inc.
GETGO Grilled Chicken Salad Sell By: (up to and including 3/26/15) Net Wt: 14 oz. Contains: Soy, Milk, Egg GetGo Giant Eagle Distrib...
Dairy·584 affected·Mar 24, 2015
High RiskFDA
Hamilton Medical, Inc.
Hamilton-G5 Ventilators with software versions V2.40/2.41 Catalog numbers for G5: 159001 and 159002. Software: 159700.. Intensive care ...
Respiratory Devices·248 affected·Mar 24, 2015
High RiskFDA
The Anspach Effort, Inc.
Synthes Small Battery Drive (SBD) Oscillating Saw Attachment Part Number: 532.021 for orthopedic surgery.
Medical Devices·12,085 affected·Mar 24, 2015
High RiskFDA
Carmel Food Group, Inc.
Rising Moon Organics Spinach Florentine Ravioli; Net Wt 8 oz. (227g) UPC 7 85030 22770 1 Distributed by Rising Moon Organics 313 Ir...
Produce·1,260 affected·Mar 23, 2015
High RiskFDA
Carmel Food Group, Inc.
Rising Moon Organics Garlic and Veggie Ravioli; Net Wt 8 oz. (227g) UPC 7 85030 00011 3 Distributed by Rising Moon Organics 313 Iro...
Food·1,241 affected·Mar 23, 2015
High RiskFDA
Superior Foods
Simply Balanced Organic Chopped Spinach NET WT 10 OZ (283g) steam-in-bag Needs to be fully cooked Keep frozen
Produce·8,475 affected·Mar 23, 2015
High RiskFDA
Carmel Food Group, Inc.
Rising Moon Organics Spinach & Cheese Ravioli; Net Wt 8 oz. (227g) UPC 7 85030 55561 3 Distributed by Rising Moon Organics 313 Iro...
Dairy·4,680 affected·Mar 23, 2015
High RiskFDA
Baxter Healthcare Corp
0.9% Sodium Chloride Injection, USP, 50 mL, VIAFLEX Plastic Container Multi Pack, Rx Only, Baxter Healthcare Corporation, Deerfield, IL ,...
Injectable Drugs·196,128 affected·Mar 23, 2015
High RiskFDA
Baxter Healthcare Corp
Clinimix E 5/20 sulfite-free (5% amino-acid with electrolytes in 20% dextrose with calcium) Injection, 2000 mL in Dual Chamber Container,...
Injectable Drugs·7,444 affected·Mar 23, 2015
High RiskFDA
Roche Diagnostics Operations, Inc.
Homocysteine test system - Homocysteine Reagent. 05385415190; Homocysteine 100 Tests, cobas c, COBAS INTEGRA Homocysteine Enzymatic A...
Diagnostic Devices·2,558 affected·Mar 23, 2015
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry Lipase Reagent , Catalog Number B01-4840-01 REF: 01984894.
Diagnostic Devices·7,814 affected·Mar 23, 2015
High RiskFDA
Bd Biosciences, Systems & Reagents
CD123 (9F5) PE Catalog number 649453 Analyte Specific Reagent
Diagnostic Devices·9 affected·Mar 23, 2015
High RiskFDA
Philips Electronics North America Corporation
Philips DigitalDiagnost Release 4.0.3, Release 4.1/4.1.1. excluding systems with SP1 Product Usage: The DigitalDiagnost is intended...
Diagnostic Devices·62 affected·Mar 23, 2015
High RiskFDA
Sedecal Usa, Inc.
Sedecal SA Mobile Diagnost w DR x-ray system
Diagnostic Devices·145 affected·Mar 23, 2015
High RiskFDA
Medtronic Inc. Cardiac Rhythm Disease Management
Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx only. Models BVT608010V01, BVT608030V01, BVT612010V01, BVT61...
Medical Devices·8,269 affected·Mar 23, 2015
High RiskFDA
Edwards Lifesciences, Llc
Edwards Lifesciences Fem-Flex II Femoral Arterial Cannula 8, 10, 12 French,Sterile EO, Rx Only, Manufacturer Edwards Lifesciences LLC, I...
Medical Devices·5,125 affected·Mar 23, 2015
High RiskFDA
Bard Peripheral Vascular Inc
Bard ConQuest PTA Balloon Dilatation Catheter, 12mm Balloon Size, Product Code: CQ-75124.
Surgical Devices·2,620 affected·Mar 23, 2015
High RiskFDA
Amys Kitchen Inc
Amy's Gluten Free Tofu Scramble Breakfast Wraps, 5.5 oz 156 g) 12 boxes per case. UPC: 0-42272-00807-0, US distribution only; UPC : 0-4...
Food·102 affected·Mar 22, 2015
High RiskFDA
Amys Kitchen Inc
Amy's Gluten Free Vegetable Lasagna, 4.7 oz. 6 boxes per case. Amy Kitchen, Petaluma, CA
Produce·2,093 affected·Mar 22, 2015
High RiskFDA
Amys Kitchen Inc
Amy's Tofu Scramble, 9.0 oz (255 g) 12 boxes per case. UPC: 0-42272-00054-8, US distribution only Amy Kitchen, Petaluma, CA
Food·1,822 affected·Mar 22, 2015
High RiskFDA
Amys Kitchen Inc
Amy's Gluten Free Dairy Free Vegetable Lasagna, 9.0 oz (255 g) 12 boxes per case. UPC: 0-42272-00814-8 US distribution only; UPC: 0-422...
Dairy·2,851 affected·Mar 22, 2015
High RiskFDA
Amys Kitchen Inc
Amy's Tofu Vegetable Lasagna, 9.5 oz (269 g) 12 boxes per case. UPC 0-42272-00033-3, US distribution only Amy's Kitchen, Petaluma, CA
Produce·1,478 affected·Mar 22, 2015
High RiskFDA
Amys Kitchen Inc
Amy's Brown Rice & Vegetables Bowl, 10.0 oz (284 g) 12 boxes per case. UPC: 0-42272-00161-3 , US distribution only Amy Kitchen, Petal...
Produce·2,828 affected·Mar 22, 2015
High RiskFDA
Amys Kitchen Inc
Amy's Vegetable Lasagna, 9.5 oz (269 g) 12 boxes per case. UPC 0 42272 00032 6 - US Distribution: UPC 0-42272-90032-9 - Canadian distri...
Produce·18,101 affected·Mar 22, 2015
High RiskFDA
Amys Kitchen Inc
Amy's Brown Rice & Vegetables Bowl, Light in Sodium, 9.5 oz (269 g) 12 boxes per case. UPC: 0-42272-00240-5, US distribution only; UPC ...
Produce·2,278 affected·Mar 22, 2015
High RiskFDA
Amys Kitchen Inc
Amy's Stuffed Pasta Shells Bowl, 10.0 oz (284 g) 12 boxes per case. UPC: 0-42272-00178-1, US distribution only Amy Kitchen, Petaluma, CA
Food·759 affected·Mar 22, 2015
High RiskFDA
Amys Kitchen Inc
Amy's Spinach Pizza 14.0 oz (397 g) 8 boxes per case. UPC: 0-42272-00102-6, US distribution only Amy Kitchen, Petaluma, CA
Produce·14,863 affected·Mar 22, 2015
High RiskFDA
Smiths Medical Asd, Inc.
Smiths Medical, BCI Advisor Vital Signs Monitor, Product Reorder No 92M774325A.
Medical Devices·5 affected·Mar 21, 2015
High RiskFDA
Twin City Foods Inc
Wegmans Organic Just Picked Spinach, 12 oz.(340g) frozen packages, UPC 77890 32932
Produce·1,045 affected·Mar 20, 2015
High RiskFDA
Twin City Foods Inc
Wild Harvest Organic Cut Leaf Spinach, 16 oz. (454 g) frozen packages, UPC 11535 50170
Produce·1,979 affected·Mar 20, 2015
High RiskFDA
Axis-shield Diagnostics, Ltd.
Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT; 100 test format, 1000 test format, and 200 test format; and Private Label: (D...
Diagnostic Devices·52 affected·Mar 20, 2015
High RiskFDA
Giant Eagle, Inc.
GetGo Giant Eagle Strawberry Yogurt Parfait Sell By: (up to and including) 3/24/2015 Distributed by: Giant Eagle, Inc., Pittsburgh, PA...
Dairy·1,682 affected·Mar 19, 2015
High RiskFDA
Biosense Webster, Inc.
SMARTABLATE RF Generator System, Catalog No. M490006, M490007, M4900106, and M4900107. Product Usage: The use of the SMART ABLATE Gen...
Cardiac Devices·115 affected·Mar 19, 2015
High RiskFDA
A I Foods Corporation
Banana Langka Empanada (6.5 oz), 24 units/case, UPC 0 30283 16483 0
Food·2 affected·Mar 18, 2015
High RiskFDA
A I Foods Corporation
Lumpia Vegetable with Shrimp, Net Wt. 20 oz., 12 units/case, UPC 0 30283 15027 7, UPC 0 30283 16397 0.
Seafood·92 affected·Mar 18, 2015
High RiskFDA
A I Foods Corporation
Ube Macapuno Empanada, Net Wt. 6.5 oz, 24 units/case Net Wt. 6.5 oz., UPC 0 30283 16482 3
Food·2 affected·Mar 18, 2015
High RiskFDA
A I Foods Corporation
Lumpia Vegetable (20 oz), 12 units/case, UPC 0 30283 16272 0
Produce·54 affected·Mar 18, 2015
High RiskFDA
A I Foods Corporation
Cheesetix (Cheese Lumpia) 12.6 oz, 20 units/case, UPC 0 30283 16542 4
Dairy·26 affected·Mar 18, 2015
High RiskFDA
A I Foods Corporation
Seafood Eggroll Lumpiang Shanghai, Reg. Size 34 oz, 9 units/case, UPC 7 95981 09175 7
Seafood·47 affected·Mar 18, 2015
High RiskFDA
Baxter Healthcare Corp.
5% Dextrose Injection, USP, 1000mL in VIAFLEX Plastic Container, Rx only, Manufactured by Baxter Healthcare Corp., North Cove, North Caro...
Injectable Drugs·48,874 affected·Mar 18, 2015
High RiskFDA
Baxter Healthcare Corp.
0.9% Sodium Chloride Injection, USP, 500 mL in VIAFLEX Plastic Container, Rx only, Manufactured by Baxter Healthcare Corp., North Cove, N...
Injectable Drugs·597,498 affected·Mar 18, 2015
High RiskFDA
Hansen Medical Inc
Magellan Robotic System; Model No(s). 11132 and 11139. A steerable catheter control system used at clinical sites.
Surgical Devices·19 affected·Mar 18, 2015
High RiskFDA
Biomet, Inc.
LOW PROFILE NON-LOCK SCREW; 2.7mm x 22 mm; REF 131227222; LOT RM105E. Provides the orthopaedic surgeon a means of bone fixation and h...
Medical Devices·45 affected·Mar 18, 2015
High RiskFDA
Zimmer Gmbh
Anatomical Shoulder Handle for Rasp Item: 01.04233.000 Used during total joint arthroplasty of the shoulder.
Medical Devices·30 affected·Mar 18, 2015
High RiskFDA
Kraft Foods Group Inc.
Kraft Macaroni & Cheese Boxed Dinner Original Flavor, 7.25oz.,packaged in blue and yellow cardboard box. There are four different package...
Dairy·242,000 affected·Mar 17, 2015
High RiskFDA
Fallon Wellness Pharmacy, L.l.c.
Papaverine/phentolamine/prostaglandin 16/0.5/0.005 mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110
Injectable Drugs·4 affected·Mar 17, 2015
High RiskFDA
Fallon Wellness Pharmacy, L.l.c.
Hydroxocobalamin 1) 1000mcg/mL, 2) 5mg/0.5mL, 3) 5000mcg/0.2mL injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110
Injectable Drugs·70 affected·Mar 17, 2015
High RiskFDA
Fallon Wellness Pharmacy, L.l.c.
Prostaglandin Rx, dispensed in 5 ml vials: 1) 10 mcg/mL Injection, 2) 22.5 mcg/mL Injection, 3) 45 mcg/mL Injection, 4) 60 mcg/mL Injecti...
Injectable Drugs·43 affected·Mar 17, 2015