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High RiskFDA
Medaus, Inc.
B-COMPLEX 50 IN NACL 0.9% (PF) B1-50MG, B2-5-PO4-5MG, B3-50MG, B5-50MG, B6-50MG/ML, 2ML Vials, MEDAUS PHARMACY
Drugs·1,000 affected·May 13, 2016
High RiskFDA
Medaus, Inc.
MANGANESE CHL 0.1MG/ML PF, 10ML Vials, MEDAUS PHARMACY
Drugs·1,000 affected·May 13, 2016
High RiskFDA
Datascope Corporation
MEGA¿ 7.5Fr. 30cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK¿ MEGA¿ 7.5Fr. 40cc Intra-Aortic Balloon Catheter with In...
Surgical Devices·31,030 affected·May 13, 2016
High RiskFDA
Medtronic Sofamor Danek Usa, Inc - Dallas Distribution
Saw Sagittal Catalog Number: ES 300; Saw Sagittal Refurbished Catalog Number: ES300-R; Saw Saggital, Finger Catalog Number: ES310; Saw Sa...
Surgical Devices·368 affected·May 13, 2016
High RiskFDA
Innovision A/s
Innocor Cardiopulmonary Exercise and Lung Function Testing System Non-invasive diagnostic device that measures or calculates a numbe...
Diagnostic Devices·8 affected·May 13, 2016
High RiskFDA
Ballester Hermanos, Inc.
Product in cans of 4 1/4 oz (111g) and 8 1/4 oz (220g) net weight. Label reading in part as: "Coloso***PULPO EN ACEITE***OCTOPUS IN OIL*...
Food·5,286 affected·May 12, 2016
High RiskFDA
Ballester Hermanos, Inc.
Product in cans of 4 1/4 oz and 8 1/4 oz net weight. Label reading in part as: "Coloso***PULPO AL AJILLO***OCTOPUS WITH GARLIC FLAVOR***...
Food·495 affected·May 12, 2016
High RiskFDA
Ballester Hermanos, Inc.
Product in cans of 4 1/4 oz and 8 1/4 oz net weight. Label reading in part as: "Coloso***PULPO EN ACEITE PICANTE***OCTOPUS IN HOT OIL***...
Food·166 affected·May 12, 2016
High RiskFDA
Ballester Hermanos, Inc.
Product in cans of 4 1/4 oz and 8 1/4 oz net weight. Label reading in part as: "Coloso***PULPO EN SALSA MARINERA***OCTOPUS IN PICKLED SAU...
Food·145 affected·May 12, 2016
High RiskFDA
Baxter Healthcare Corp
COSEAL Surgical Sealant Kit, 4 mL, Product Code: 934071; For use in vascular reconstructions to achieve adjunctive hemostasis by mechani...
Surgical Devices·6,804 affected·May 12, 2016
High RiskFDA
Elekta, Inc.
iGUIDE System, for patient positioning, with assistance of a 30 Tracking System in a radiotherapy environment.
Medical Devices·20 affected·May 12, 2016
High RiskFDA
Baxter Healthcare Corp
COSEAL Surgical Sealant Kit, 8 mL, Product Code: 934072; For use in vascular reconstructions to achieve adjunctive hemostasis by mechani...
Surgical Devices·6,128 affected·May 12, 2016
High RiskFDA
Carefusion 303, Inc.
Alaris System PC Unit Model 8015 with software versions 9.17 and 9.19; Central programming, monitoring and power supply component for th...
Medical Devices·69,693 affected·May 12, 2016
High RiskFDA
Profarma Distributors Llc
1% Clotrimazol cream, 30 mg tube, UPC 501318644335
Topical Drugs·79 affected·May 11, 2016
High RiskFDA
Profarma Distributors Llc
VERMOX Tablets 500 mg, 1-count box, UPC 501109900596
Oral Drugs·254 affected·May 11, 2016
High RiskFDA
Profarma Distributors Llc
tabcin ACTIVE M.R. Capsules, 12-count box , UPC 7501008485057
Oral Drugs·42 affected·May 11, 2016
High RiskFDA
The Aloe Source
aloe SPORT liniment TOPICAL ANALGESIC 8 fl oz. tube, ALOE VERA Liniment Topical Analgesic 8 fl oz. bottle, Manufactured by Coats Interna...
Topical Drugs·577 affected·May 11, 2016
High RiskFDA
Profarma Distributors Llc
VERMOX Tablets 100 mg; 6-count box, UPC 7501109900619
Oral Drugs·163 affected·May 11, 2016
High RiskFDA
Profarma Distributors Llc
tabcin NOCHE; Capsules,12-count box, UPC 501008485033
Oral Drugs·31 affected·May 11, 2016
High RiskFDA
Medline Industries Inc
Medicine Cup, 1 OZ. Liquid medication dispenser to issue a measured amount of liquid medication.
Medical Devices·903 affected·May 11, 2016
High RiskFDA
Synthes (usa) Products Llc
Norian Drillable Inject 10 CC-Sterile; catalog # 07.704.010S Intended for bony voids or defects of the extremities and pelvis that are n...
Medical Devices·2,098 affected·May 11, 2016
High RiskFDA
Zimmer Biomet, Inc.
Persona Trabecular Metal Tibia; Persona Trabecular Metal Tibial Plate Instruments and Modular Brackets; Used to facilitate the implant...
Medical Implants·10,256 affected·May 11, 2016
High RiskFDA
Frontier Natural Products Co-op
16 oz. foil packages of Frontier Co-op Hojicha Tea Certified Organic Camellia sinensus, Norway, IA 52318
Beverages·4,338 affected·May 10, 2016
High RiskFDA
Karlsburger Foods, Inc.
Karlsburger, Mesquite Seasoning Mix & Marinade, Item 46402, Net WT 2 lbs in plastic shaker jars.
Food·256 affected·May 10, 2016
High RiskFDA
Allergan Sales, Llc
Tazorac (tazarotene) Gel 0.05%, Rx only, packaged in a) 30g (NDC 0023-8335-03) and b) 100g (NDC 0023-8335-10) tubes, Allergan Inc, Irvine...
Topical Drugs·17,802 affected·May 10, 2016
High RiskFDA
Bayer Health Care Llc
Coppertone SUNSCREEN LOTION, CLEARLY SHEER, BROAD SPECTRUM SPF 50, 5 FL OZ (147mL), OTC, Dist by: Bayer HealthCare LLC, Whippany, NJ 0798...
Drugs·37,512 affected·May 10, 2016
High RiskFDA
Allergan Sales, Llc
Tazorac (tazarotene) Gel 0.05%, 15 x 3.5g, sample packs, Allergan Inc, Irvine, CA 92612. UPC 300238335159
Topical Drugs·0 affected·May 10, 2016
High RiskFDA
Medical Vision Ab
Double Pump RF Patient Cassette; Product Number: 72204055. Intended to provide fluid distension and irrigation and fluid suction durin...
Diagnostic Devices·3,295 affected·May 10, 2016
High RiskFDA
Frozen Inc.
24 oz RM German Choc. Dessert Bar Cake. Net Wt: 24 oz, K Dairy, UPC 752716883308, Vollmer's Bakery - 4004 Grape Street - Denver, CO - 303...
Dairy·175 affected·May 9, 2016
High RiskFDA
Abbott Nutrition
Nepro Vanilla , 8oz metal can
Food·332,088 affected·May 9, 2016
High RiskFDA
Abbott Nutrition
Oxepa, 8oz metal can
Food·45,156 affected·May 9, 2016
High RiskFDA
Abbott Nutrition
Vital High Protein, 8oz metal can
Food·31,440 affected·May 9, 2016
High RiskFDA
Zydus Pharmaceuticals Usa Inc
Bromocriptine Mesylate Capsules USP, 5 mg, 30-count bottles, Rx only, Manufactured by: Cadila Healthcare ltd., Ahmedabad, India Distribut...
Oral Drugs·14,808 affected·May 9, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
Syngo.plaza, Picture archiving and communication system (PACS), Model Numbers - 10863171, 10863172, 10863173,
Medical Devices·74 affected·May 9, 2016
High RiskFDA
Datascope Corporation
Small Patient ECC Pack, REF BEQ-TOP 24100, Product Usage: The HLM Tubing Sets with Bioline Coating are for single use only. They may be ...
Cardiac Devices·17 affected·May 9, 2016
High RiskFDA
Roche Molecular Systems, Inc.
cobas¿ Liat¿ Analyzer
Medical Devices·2 affected·May 9, 2016
High RiskFDA
Intuitive Surgical, Inc.
SEAL,IS4000 PORTS,12MM&STAPLER,BOX of 10; Model numbers: 470380-04, 470380-05, 470380-06; Part number:470380. The da Vinci Xi Surgical S...
Surgical Devices·46,191 affected·May 9, 2016
High RiskFDA
Medtronic Navigation, Inc.
Visualase Cooled Laser Applicator System (VCLAS). The VCLAS system consists of the Visualase Laser Diffusing Fiber (LDF) and the Visuala...
Cardiac Devices·120 affected·May 9, 2016
High RiskFDA
Intuitive Surgical, Inc.
SEAL,IS4000 PORTS,5MM-8MM,BOX of 10; Model numbers: 470361-03, 470361-04, 470361-05, 470361-06; Part number: 470361. The da Vinci Xi Sur...
Surgical Devices·46 affected·May 9, 2016
High RiskFDA
Ajinomoto Windsor Inc., Golden Tiger Plant
TAI PEI SHRIMP FRIED RICE, 8/12 oz. pails, Product # 7007700806
Seafood·1,915,263 affected·May 6, 2016
High RiskFDA
Ajinomoto Windsor Inc., Golden Tiger Plant
TAI PEI GARDEN VEGETABLE RICE, Net Wt. 18oz (510g), 8/18 oz. pails, Product # 82070
Produce·1,915,263 affected·May 6, 2016
High RiskFDA
Ajinomoto Windsor Inc., Golden Tiger Plant
WAHOO-BATTERED VEGGIE FRIES, 6/2 lb. bags, Product # 229650
Food·1,915,263 affected·May 6, 2016
High RiskFDA
Ajinomoto Windsor Inc., Golden Tiger Plant
Toasted Onion Battered Green Beans, Net Wt. 12lb (5.44kg), 6/2 lb. bags., Product # 275720
Produce·1,915,263 affected·May 6, 2016
High RiskFDA
Ajinomoto Windsor Inc., Golden Tiger Plant
BATTERED SWEET CORN NUGGET, 6/2 lb. bags, Product # 241550, 672685
Food·1,915,263 affected·May 6, 2016
High RiskFDA
Ajinomoto Windsor Inc., Golden Tiger Plant
OLD PARK SOUTHWEST VEGETABLE SPRING ROLL, 162 ct./1.5 oz., Product # 56857
Produce·1,915,263 affected·May 6, 2016
High RiskFDA
Ajinomoto Windsor Inc., Golden Tiger Plant
Battered Corn Nugget, Net Wt. 32oz (2lbs) 907g, 6/2lb bags, 4/3lb bags, Product #241120, 241620. UPC: 10050650024115
Food·1,915,263 affected·May 6, 2016
High RiskFDA
Ajinomoto Windsor Inc., Golden Tiger Plant
VIP-STEAMWORKS ORGANIC PEAS, 6 pk./24 oz., Product # 7007706464
Food·1,915,263 affected·May 6, 2016
High RiskFDA
Ajinomoto Windsor Inc., Golden Tiger Plant
TAI PEI PDQ SHRIMP FRIED RICE, Net Wt. 12 oz (340g), 9/12 oz. pails, Product # 82072
Seafood·1,915,263 affected·May 6, 2016