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High RiskFDA
Zimmer Trabecular Metal Technology, Inc.
NexGenTrabecular Metal Tibial Half Block Augment, Left Lateral/Right Medial, Size 4 5MM Thickness W/Screws Item Number: 00544800436 ...
Medical Devices·26 affected·Feb 1, 2019
High RiskFDA
Becton Dickinson & Company
3mL Safety-Lok Syringe, Catalog Number 309606, UDI 30382903096061
Medical Devices·428,800 affected·Feb 1, 2019
High RiskFDA
Zimmer Trabecular Metal Technology, Inc.
NexGenTrabecular Metal Tibial Half Block Augment, Right Lateral/Left Medial, Size 4 5MM Thickness W/Screws Item Number: 00544800426 ...
Medical Devices·24 affected·Feb 1, 2019
High RiskFDA
Dr. Reddy's Laboratories, Inc.
Divalproex Sodium Extended-release Tablets, USP 250 mg, 100-count bottle, Rx only, Mfd.By: Dr. Reddy's Laboratories Limited Bachupally - ...
Oral Drugs·10,656 affected·Jan 31, 2019
High RiskFDA
Medline Industries Inc
Semi-Rigid Suction Canister, 3000cc. Model Numbers OR530 and OR530H. For OR530, the product comes in a case with two boxes. One box inc...
Medical Devices·750 affected·Jan 31, 2019
High RiskFDA
Dunkin Brands Inc
DUNKIN' DONUTS MULTIGRAIN BAGEL DOUGH PRODUCT APPROVED BY: DUNKIN'DONUTS Unit wt: 4.5oz Count: 104 units Net Wt: 29 lb 4 oz (13.3 kg) 007...
Food·9,779 affected·Jan 30, 2019
High RiskFDA
1908 Brands
Bundle Organics Bar Salty Nuts and Seeds, 1.9 Oz snack bar, Ambient storage
Snacks & Candy·2,597 affected·Jan 30, 2019
High RiskFDA
1908 Brands
Bundle Organics Bar Oatmeal Raisin, 1.9 Oz snack bar, Ambient storage
Snacks & Candy·3,045 affected·Jan 30, 2019
High RiskFDA
1908 Brands
Bundle Organics Bar Chocolate-Maca, 1.9 Oz snack bar, Ambient storage
Snacks & Candy·2,534 affected·Jan 30, 2019
High RiskFDA
1908 Brands
Bundle Organics Bar Carrot Walnut, 1.9 Oz snack bar, Ambient storage
Snacks & Candy·4,537 affected·Jan 30, 2019
High RiskFDA
1908 Brands
Bundle Organics Bar Chocolate Chip, 1.9 Oz snack bar, Ambient storage
Snacks & Candy·2,781 affected·Jan 30, 2019
High RiskFDA
Matrix Surgical Holdings, Llc
OMNIPORE Surgical Implant Petite Paranasal - Left - Product Usage: OmniPore Surgical Implants in block, sheet, and anatomical shapes ar...
Medical Implants·46 affected·Jan 30, 2019
High RiskFDA
U&i Corp.
Velofix SA cervical cage, REF: TSA161207, TSA161208, TSA161209, TSA161210, TSA161407, TSA161408, TSA161409, TSA161410 - Product Usage:The...
Medical Devices·42 affected·Jan 30, 2019
High RiskFDA
Matrix Surgical Holdings, Llc
OMNIPORE Surgical Implant Petite Paranasal - Right - Product Usage: OmniPore Surgical Implants in block, sheet, and anatomical shapes ar...
Medical Implants·42 affected·Jan 30, 2019
High RiskFDA
Us Compounding Inc
Ephedrine Sulfate, 50 mg/10 mL, 10 mL Single Use Syringe, Rx only, US Compounding Pharmacy 1270 Don's Lane Conway, AR 800-718-3588, Barco...
Drugs·1,686 affected·Jan 29, 2019
High RiskFDA
Collins Aerospace
TASE 400 Imaging systems
Medical Devices·433 affected·Jan 29, 2019
High RiskFDA
Collins Aerospace
TASE 500 Imaging systems
Medical Devices·433 affected·Jan 29, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc.
ACUSON NX2 Elite Diagnostic Ultrasound System, Model # 11284500, RX Only, Siemens Medical Solutions, containing software version VA10A, ...
Cardiac Devices·70 affected·Jan 28, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc.
ACUSON NX3 Diagnostic Ultrasound System, Model # 11235612, RX Only, Siemens Medical Solutions, containing software versions: VA10A, VA1...
Cardiac Devices·1,384 affected·Jan 28, 2019
High RiskFDA
Spacelabs Healthcare, Inc.
Spacelabs Healthcare Smart Disclosure System, Model 92810, a component of the Intesys Clinical Suite (ICS) G2.
Medical Devices·295 affected·Jan 28, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc.
ACUSON NX3 Elite Diagnostic Ultrasound System, Model # 11235411, RX Only, Siemens Medical Solutions, containing software versions: VA10...
Cardiac Devices·2,262 affected·Jan 28, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc.
ACUSON NX2 Diagnostic Ultrasound System, Model # 11284381, RX Only, Siemens Medical Solutions, containing software version VA10A, VA10B,...
Cardiac Devices·1,869 affected·Jan 28, 2019
High RiskFDA
Medrobotics Corporation
Obturator (long cone), Part number 25162 Product Usage: The obturator is a component of the Flex Rectoscope which is an accessory to ...
Surgical Devices·35 affected·Jan 25, 2019
High RiskFDA
Philips North America, Llc
Fetal Spiral Electrode, Model No. 9898 031 37631
Medical Devices·1,971,925 affected·Jan 25, 2019
High RiskFDA
Us Compounding Inc
LET Gel 4% (Lidocaine HCl 4% + EPINEPHrine HCl 0.05% + Tetracaine HCl 0.5%), 3mL Single Use Syringe, Rx only, US Compounding, 1270 Don's ...
Topical Drugs·1,931 affected·Jan 24, 2019
High RiskFDA
Sun Pharmaceutical Industries, Inc.
BromSite (bromfenac ophthalmic solution) 0.075%, 5 mL bottles, Rx Only, Distributed by : Sun Pharmaceutical Industries, Inc. Cranbury, NJ...
Ophthalmic Drugs·69,840 affected·Jan 24, 2019
High RiskFDA
Maquet Cardiovascular, Llc
AXIUS Blower Mister Product Code/REF Number: CB-1000 The Axius Blower Mister is intended to clear an anastomotic site for improved vi...
Medical Devices·7,880 affected·Jan 24, 2019
High RiskFDA
Gilda Industries, Inc.
Gilda Industries, Panque - Butter Pound Cake, Manufactured by and Distributed for Gilda Industries
Dairy·20 affected·Jan 22, 2019
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products Na+ Slides, Catalog Number 8379034 For in vitro diagnostic use only. VITROS Na+ Slides quantitatively measur...
Diagnostic Devices·1,448 affected·Jan 22, 2019
High RiskFDA
Atricure, Inc.
COBRA FUSION 150 Ablation System (International Only), Catalog # (REF) 700-001MI
Medical Devices·765 affected·Jan 22, 2019
High RiskFDA
Atricure, Inc.
COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001S
Medical Devices·175 affected·Jan 22, 2019
High RiskFDA
Atricure, Inc.
COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001
Medical Devices·6,176 affected·Jan 22, 2019
High RiskFDA
Atricure, Inc.
COBRA FUSION 50, Ablation System, Catalog # (REF) 700-002
Medical Devices·1,288 affected·Jan 22, 2019
High RiskFDA
Pbm Nutritionals, Llc
Parent's Choice Toddler Next Stage¿ Milk Drink Powder Natural Milk Flavor With Other Natural Flavors, Stage 3, 1 Year and Up, NET WT 24 O...
Dairy·18,632 affected·Jan 21, 2019
High RiskFDA
Perrigo Company Plc
Simple Truth Organic Banana, Strawberry & Apple Fruit Puree with Nonfat Greek Yogurt, 113 g, packed in a laminate pouch, Each case has 6 ...
Dairy·106,632 affected·Jan 21, 2019
High RiskFDA
Stryker Gmbh
Instrument Tray, Basic T2 Femur Long Catalog #: 1806-9900 Product Usage: Knee Arthroplasty
Medical Devices·17 affected·Jan 21, 2019
High RiskFDA
Ge Healthcare, Llc
Revolution CT scanners Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography app...
Cardiac Devices·857 affected·Jan 19, 2019
High RiskFDA
Mrs Grissom's Salads, Inc
Mrs GRISSOM'S SELECT OLD FASHIONED PIMENTO CHEESE**Mrs. GRISSOM'S SELECT CRANBERRY PECAN CHICKEN SALAD**INGREDIENTS: Sugar, Cider Vinegar...
Dairy·407 affected·Jan 18, 2019
High RiskFDA
Prinston Pharmaceutical Inc
Irbesartan and Hydrochlorothiazide Tablets, USP 300/12.5 mg Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xunqiao, Li...
Oral Drugs·32,692 affected·Jan 18, 2019
High RiskFDA
Mylan Pharmaceuticals Inc.
Fexofenadine HCl Tablets, USP, 180 mg, packaged in a) 30-count bottles (NDC 0378-0782-93) and b) 500-count bottles (NDC 0378-0782-05); Ma...
Oral Drugs·88,090 affected·Jan 18, 2019
High RiskFDA
Prinston Pharmaceutical Inc
Irbesartan Tablets 300 mg 90 count Rx only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Xunqiao, Linhai, Zhejiang 317024 Chi...
Oral Drugs·19,800 affected·Jan 18, 2019
High RiskFDA
Prinston Pharmaceutical Inc
Irbesartan and Hydrochlorothiazide Tablets, USP 300/12.5 mg Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xunqiao, Li...
Oral Drugs·12,294 affected·Jan 18, 2019
High RiskFDA
Prinston Pharmaceutical Inc
Irbesartan and Hydrochlorothiazide Tablets, USP 150/12.5 mg Rx 30 Tablets Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. ...
Oral Drugs·87,505 affected·Jan 18, 2019
High RiskFDA
Mylan Institutional, Inc. (d.b.a. Udl Laboratories)
Alprazolam Tablets, USP, 0.25 mg, 10x10 per carton, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC...
Oral Drugs·10,281 affected·Jan 18, 2019
High RiskFDA
Prinston Pharmaceutical Inc
Irbesartan and HydrochlorothiazideTablets, USP 150/12.5 mg Rx Only 90 count Manufactured by: Zhejiang Huahai Pharmaceutical Co., Xunq...
Oral Drugs·2,177 affected·Jan 18, 2019
High RiskFDA
Bellus Medical
SKINFUSE Resuce Calming Complex Kit containing: SKINFUSE LIFT HG - Product Usage: The SKINFUSE Rescue Calming Complex is intend to be us...
Medical Devices·6,007 affected·Jan 18, 2019
High RiskFDA
Friendly Fruit Market Dba Sid Wainer & Son
JANSAL VALLEY Cocoa Dusted Chocolate Covered Almonds, Net Weight: 6 OZ (170 G), packed in a plastic clamshell, UPC: 7 08152 32988 7
Snacks & Candy·52 affected·Jan 17, 2019
High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Medtronic Power Supply 26907, Medtronic CareLink Encore(TM) 29901 Programmer
Medical Devices·731 affected·Jan 17, 2019