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High RiskFDA
Noven Pharmaceuticals, Inc.
Daytrana (methylphenidate transdermal system) Delivers 15 mg over 9 hours (1.6 mg/hr) Rx Only Contains: 30 Patches Manufactured for: Nov...
Topical Drugs·234,960 affected·Aug 30, 2017
High RiskFDA
Noven Pharmaceuticals, Inc.
Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Rx Only Contains: 30 Patches Manufactured for: Nov...
Topical Drugs·321,900 affected·Aug 30, 2017
High RiskFDA
Carl Zeiss Meditec Ag
Carl Zeiss INTRABEAM PRS 500, product #304534-0000-500. The firm name on the label is Carl Zeiss Meditec AG, Jena, Germany. The INTRABE...
Medical Devices·9 affected·Aug 30, 2017
High RiskFDA
Becton Dickinson & Company
BD Vacutainer¿ K2 EDTA (K2E) 3.6mg Blood Collection Tube (13 x 75 mm x 2.0 mL). Catalog Number: 367841. Used for whole blood hematolo...
Medical Devices·8,494,000 affected·Aug 29, 2017
High RiskFDA
Gonzalez Wholesale Distributor,l
Primera Negra, Artificial Vanilla Flavoring NET WT 4 OZ and 8 OZ
Food·25 affected·Aug 28, 2017
High RiskFDA
Bateman Community Living
Breaded Fish with Vera Cruz Sauce; In 13.4 oz 3 compartment tray that has the fish, rice pilaf and green peas. Item number KD-0003 No ...
Seafood·8,792 affected·Aug 28, 2017
High RiskFDA
Tomanetti Food Products Inc
12" homestyle pizza crusts packed 18 to a case (no consumer packaging) labeled as: Tomanetti Pizza Crusts with the 18-12" Homestyle 9111...
Frozen Food·132 affected·Aug 28, 2017
High RiskFDA
St Jude Medical Inc.
Assurity MRI Model Numbers: PM1272, PM2272 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is i...
Medical Implants·164,366 affected·Aug 28, 2017
High RiskFDA
St Jude Medical Inc.
PM1226 ACCENT ST MRI SR RF and PM2222 ACCENT ST These low voltage (LV) devices are implantable pacemaker pulse generators, intended to b...
Medical Implants·101 affected·Aug 28, 2017
High RiskFDA
St Jude Medical Inc.
Assurity Model Numbers: PM1240, PM2240; Assurity + Model Number: PM2260; Accent Model Numbers: PM1210, PM2210, PM1222, PM2212; Accent MRI...
Medical Implants·529,912 affected·Aug 28, 2017
High RiskFDA
Zimmer Biomet, Inc.
Persona Partial Knee System Product Usage: The Persona Partial Knee System instruments are used by a surgeon to facilitate the implan...
Medical Implants·1,275 affected·Aug 28, 2017
High RiskFDA
St Jude Medical Inc.
Merlin@Home Software Model EX2000 v8.2.2 for Merlin@Home Transmitter Models EX1150, EX1150W, EX1100, and EX1100W. The Merlin@home Transm...
Medical Implants·495,011 affected·Aug 28, 2017
High RiskFDA
St Jude Medical Inc.
PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF These low voltage (LV) devices are implantable pacemaker pulse ge...
Medical Implants·2,741 affected·Aug 28, 2017
High RiskFDA
St Jude Medical Inc.
Merlin PCS 3650 Programmer with Model 3330 Software Version 23.1.1 The Merlin Patient Care System (PCS) Model 3650 Programmer is a porta...
Medical Implants·10,453 affected·Aug 28, 2017
High RiskFDA
St Jude Medical Inc.
Anthem Model Numbers: PM3210, PM3212; Allure/Relieve Model Numbers: PM3222, PM3242, PM3262, PM3542, PM3224, PM3244 Implantation of a sin...
Medical Implants·102,684 affected·Aug 28, 2017
High RiskFDA
Biomerieux Inc
VITEK(R) 2 GP, REF 21342, IVD, UDI 03573026131920, bioMerieux, Inc. VITEK(R) 2 is an automated system consisting of instruments, softwar...
Medical Implants·11,703 affected·Aug 25, 2017
High RiskFDA
Zimmer Biomet, Inc.
G7 DUAL MOBILITY LINER 44MM F Product Usage: Intended for use in hip arthroplasty cases which involves the removal of the damaged joi...
Medical Implants·8 affected·Aug 25, 2017
High RiskFDA
Zimmer Biomet, Inc.
AGC 2000 LP Patella, labeled as AGC Porous Patellar SM, Model Number 150802. Product Usage: For use in Total Knee Arthroplasty.
Medical Devices·28 affected·Aug 25, 2017
High RiskFDA
Handsome Brook Farm, Llc
Handsome Brook Farm Soy-Free Organic Pasture-Raised Eggs, UPC 8-66332-00011-4. The product is packaged in a tan, paper pulp egg carton wi...
Food·15,975 affected·Aug 24, 2017
High RiskFDA
House Of Spices India, Inc.
Laxmi Rusks, 10.58 OZ (300 gram) bags; UPC Code: 7 23246 26482 0
Food·0 affected·Aug 24, 2017
High RiskFDA
Dedinas Franzak Enterprises Dba Cheeze Kurls Inc.c.
Big Win Butter Popcorn, 5 oz., Butter Popcorn Artificially Flavored; Uncle Ray's 10 oz., Gourmet Select 12 oz., Gold Emblem 5 oz., and Sp...
Dairy·23,020 affected·Aug 24, 2017
High RiskFDA
Firefly Medical, Inc.
IVEA Product Part Number 16100 Model 500A
Medical Devices·570 affected·Aug 24, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc
AArtis Q/ Q.Zen biplane Artis zee biplane Product Usage: Artis is a family of dedicated angiography systems developed for single and bi...
Diagnostic Devices·265 affected·Aug 24, 2017
High RiskFDA
Beckman Coulter Inc.
Lyophilized Chemistry Calibrator Level 1 Product Usage: Beckman Coulter Chemistry Calibrators are intended for use when calibrating ...
Diabetes Devices·0 affected·Aug 24, 2017
High RiskFDA
Inopak Ltd
Option Systems Antibacterial Foaming Hand Wash, 0.3% P.C.M.X., 8 fl oz and 18 fl oz. bottles and 500, mL 800 mL, and 1000 mL pouches, ALS...
Drugs·0 affected·Aug 23, 2017
High RiskFDA
Inopak Ltd
Mild Healthcare Antibacterial Hand Soap, 6% P.C.M.X., 1000 mL and 2000 mL Disc Pump, 800 mL Universal Valve, and 1 gallon bottles, Inopa...
Drugs·0 affected·Aug 23, 2017
High RiskFDA
Inopak Ltd
Choice Antibacterial Hand Soap, (ethyl alcohol 61%) 800 ml/ 27 fl oz, Universal Valve, Inopak LTD, Ringwood, NJ
Drugs·0 affected·Aug 23, 2017
High RiskFDA
Philips Electronics North America Corporation
IntelliVue Multi Measurement Server, IntelliVue Multi Measurement Server SLCP, IntelliVue Multi Measurement Server X2, IntelliVue Patient...
Medical Devices·7,071 affected·Aug 23, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc
Syngo.plaza systems with SW VB20A, Model Number - 10863171, 10863172, 10863173 Product Usage: Syngo.plaza is a Picture Archiving and ...
Medical Devices·76 affected·Aug 23, 2017
High RiskFDA
The Binding Site Group, Ltd.
Human Alpha-1-Antitrypsin Kit for use on the SPAPlus analyser, Product #NK034.S. The firm name on the label is The Binding Site Group Lt...
Medical Devices·361 affected·Aug 23, 2017
High RiskFDA
Joy's International Foods
Joy's Gourmet Olive Tapenade, All Natural, Net Wt. 10 OZ. (280g).
Food·36 affected·Aug 22, 2017
High RiskFDA
Joy's International Foods
Joy's Gourmet Garlic Joy All Natural Alla Vodka, Sugar Free Gluten Free, Net Wt. 32 Oz. (1000g)
Food·26 affected·Aug 22, 2017
High RiskFDA
Joy's International Foods
Joy's Gourmet Olive Tapenade with Blue Cheese, All Natural, Net Wt. 10 OZ. (280g)
Dairy·12 affected·Aug 22, 2017
High RiskFDA
Joy's International Foods
Joy's Gourmet Artichoke Salad, All Natural, Net Wt. 10 OZ. (280g).
Produce·0 affected·Aug 22, 2017
High RiskFDA
Joy's International Foods
Joy's Gourmet Pesto, All Natural, Net Wt. 4 OZ.
Food·9 affected·Aug 22, 2017
High RiskFDA
Joy's International Foods
Joy's Gourmet Olive Salad, All Natural, Net Wt. 10 OZ. (280g).
Produce·16 affected·Aug 22, 2017
High RiskFDA
Sage Products Inc
Toothette Oral Care Suction Toothbrushes with Perox-A-Mint solution. Contains 2 Suction Toothbrushes with sodium bicarbonate, 0.25 fl oz/...
Oral Drugs·6,472 affected·Aug 22, 2017
High RiskFDA
Sage Products Inc
Q Care RX Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse. Contains 1 Covered Yankauer and Y-Conne...
Oral Drugs·4,298 affected·Aug 22, 2017
High RiskFDA
Sage Products Inc
Toothette Suction Toothbrush with Perox-A-Mint solution and Mouth Moisturizer. Includes 0.25 fl.oz./7mL Perox-A-Mint solution, 0.07oz/2g...
Drugs·38,792 affected·Aug 22, 2017
High RiskFDA
Sage Products Inc
Toothette Oral Care Short-Term Oral Swab System with Perox-A-Mint solution, Contains 20 Toothette Plus Oral Swabs with sodium bicarbonate...
Oral Drugs·25,409 affected·Aug 22, 2017
High RiskFDA
Sage Products Inc
Toothette Oral Care Suction Toothbrushes with Antiseptic Oral Rinse and Mouth Moisturizer, Contains 2 Suction Toothbrushes with sodium bi...
Oral Drugs·887 affected·Aug 22, 2017
High RiskFDA
Sage Products Inc
Q Care Continue Care for the non-ventilated patient. Contains, 1 Covered Yankauer, 3 Suction Toothbrush packages with Corinz Antiseptic C...
Oral Drugs·2,938 affected·Aug 22, 2017
High RiskFDA
Sage Products Inc
Oral Cleansing & Suctioning System q2 with 0.12% Chlorexidine Gluconate (CHG) Oral Rinse. Contains 1 Covered Yankauer and Y-Connector, 2 ...
Oral Drugs·2,424 affected·Aug 22, 2017
High RiskFDA
Sage Products Inc
Q Care Oral Cleansing & Suctioning System compatible with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse. Contains 1 Covered Yankauer and...
Oral Drugs·1,273 affected·Aug 22, 2017
High RiskFDA
Sage Products Inc
Q.Care, Oral Cleansing & Suctioning System q4. Contains: 1 Covered Yankauer and Y-Connector, 2 Suction Toothbrush packages and Antiplaque...
Oral Drugs·1,182 affected·Aug 22, 2017
High RiskFDA
Sage Products Inc
Q.Care Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse q2. Contains 1 Covered Yankauer and Y-Conne...
Oral Drugs·60 affected·Aug 22, 2017
High RiskFDA
Shata Trading, Inc.
No. 1 Faiza Beauty Cream Manufactured by: Poonia Brothers (Pak), Gujranwala, Distributed by Shata Traders Inc., 4, 19th Street, Brooklyn...
Topical Drugs·96 affected·Aug 22, 2017
High RiskFDA
Sage Products Inc
Q Care Continue Care for the non-ventilated patient. Contains, 1 Covered Yankauer, 2 Suction Toothbrush packages with Corinz Antiseptic C...
Oral Drugs·5,217 affected·Aug 22, 2017