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High RiskFDA
Genentech Inc
Xolair (omalizumab) Injection, 150 mg/1 mL, 1 prefilled syringe, Rx Only, For Subcutaneous Use. Single-Dose Prefilled Syringe. Product of...
Injectable Drugs·88,620 affected·Jun 9, 2021
High RiskFDA
Pfizer Inc.
Chantix (varenicline) tablets, 0.5mg*, 56 Tablets, Rx Only, Distributed by Pfizer Labs, Division of Pfizer Inc., NY, NY 10017, Made in Ir...
Oral Drugs·59,232 affected·Jun 9, 2021
High RiskFDA
World Source Llc
QiYu Hand Sanitizer Gel, ethanol, 500 mL bottles (pump), Manufacturer Guangzhou Minghui Cosmetics Co., Ltd., Baiyun District, Guanzhou
Topical Drugs·6,300 affected·Jun 9, 2021
High RiskFDA
Pfizer Inc.
Chantix (varenicline) tablets, 1 mg, 56 Tablets, Rx Only, Distributed by Pfizer Labs, Division of Pfizer Inc., NY, NY 10017, Made in Irel...
Oral Drugs·696,396 affected·Jun 9, 2021
High RiskFDA
Pfizer Inc.
Chantix (varenicline)Tablets, Contains: 1 Starting Week (0.5 mg* x 11 tablets), 3 Continuing Weeks (1 mg x 42 tablets), Rx Only, Distribu...
Oral Drugs·350,985 affected·Jun 9, 2021
High RiskFDA
Cordis Corporation
Avanti¿+ Catheter Sheath Introducer - Product Usage: Is indicated for use in arterial and venous procedures requiring percutaneous introd...
Surgical Devices·680 affected·Jun 9, 2021
CriticalFDA
Cardinal Health 200, Llc
Infant Heel Warmer with Attachment Tab, Nonsterile, Active Product SKU MH00002T The infant heel warmer is activated at the point of ...
Medical Devices·926,425 affected·Jun 9, 2021
High RiskFDA
Fo-nd, Llc. (dba Firebird Artisan Mills)
Firebird Artisan Mills Gluten Free Organic Brown Rice Flour, Net Wt: 50 lb / 22.7 kg. 500 North St W., Harvey, ND 58341
Food·31,300 affected·Jun 8, 2021
High RiskFDA
Beechnut Nutrition
Beech-Nut brand Single Grain Rice Baby Cereal; NET WT. 8 OZ (227g); INGREDIENTS: Rice flour, sunflower lecithin; packaged in an 8oz plast...
Bakery & Grains·8,831 affected·Jun 8, 2021
RecallFDA
Prisma Health Outsourcing Facility
Ketamine HCl Injection Solution, 10 mg / 2 mL (5 mg/mL), Rx Only, Compounded by Prisma Health Outsourcing Facility 1071 Holland Rd. Suite...
Injectable Drugs·109 affected·Jun 8, 2021
RecallFDA
Bausch Health Companies, Inc.
Mephyton (Phytonadione) 5 mg tablets, 100-count tablets, Rx Only, Manufactured for: Valeant Pharmaceuticals North America, LLC, Bridgewat...
Oral Drugs·2,691 affected·Jun 8, 2021
RecallFDA
Bausch Health Companies, Inc.
Phytonadione Tablets, 5 mg, 30-count ablets, Rx only, Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals ...
Oral Drugs·37,797 affected·Jun 8, 2021
High RiskFDA
Philips North America Llc
728333 Spectral CT 7500 -Computed Tomography X-ray system
Medical Devices·1 affected·Jun 8, 2021
High RiskFDA
Philips North America Llc
728332 IQon Spectral CT-Computed Tomography X-ray system
Medical Devices·0 affected·Jun 8, 2021
High RiskFDA
Philips North America Llc
728327 Ingenuity CT Upgrades-Computed Tomography X-ray system
Medical Devices·3 affected·Jun 8, 2021
High RiskFDA
Philips North America Llc
728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iCT Upgrades
Medical Devices·3 affected·Jun 8, 2021
High RiskFDA
Pear Therapeutics, Inc.
reSET-O Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment.
Medical Devices·3,370 affected·Jun 7, 2021
High RiskFDA
Medtronic Vascular, Inc.
Endurant II/Endurant IIs Stent Graft System: Medtronic Endurant II Stent Graft System REF ETUF3214C102EE, ETCF3636C49EE, ETBF3216C166E...
Medical Implants·18 affected·Jun 7, 2021
High RiskFDA
Pear Therapeutics, Inc.
reSET Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment.
Medical Devices·812 affected·Jun 7, 2021
High RiskFDA
Bomunity Ltd Co
Paximune Dietary Supplement Contains Bovine Proteins that help Promote Health and help Modulate Immunity 2 Fl. Oz. (60ml) packaged in dar...
Supplements·3,540 affected·Jun 4, 2021
CriticalFDA
Lakeview Farms Llc
Smilin' Bob's All Natural Smoked Fish Dip 8 oz plastic container 12 per case
Seafood·48 affected·Jun 4, 2021
CriticalFDA
Tulkoff Food Products, Inc.
Tulkoff Spicy Kimchi Aioli, 18 fl oz Clear Plastic Squeeze bottle, item number 098001, lot number 09.18.2021M, 8 bottles per case, keep r...
Food·140 affected·Jun 4, 2021
CriticalFDA
Olde Thompson, Llc
Olde Thompson Organic Ground Coriander 1.5oz. in glass jar with flip-top lid. Sun Harvest Organic Coriander 1.5oz in glass jar with flip...
Food·800 affected·Jun 4, 2021
CriticalFDA
Lakeview Farms Llc
Smilin' Bob's Key West Style Smoked Fish Dip Original 8 oz and 15.5 oz plastic container 12 per case
Seafood·1,213 affected·Jun 4, 2021
RecallFDA
Dr. Reddy's Laboratories, Inc.
Atorvastatin Calcium Tablets, USP 10 mg, 500-count bottles, Rx Only, Dr. Reddy's Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally, 5...
Oral Drugs·5,984 affected·Jun 4, 2021
High RiskFDA
Simpleware Product Group, Synopsys Northern Europe
Simpleware ScanIP software. For transfer of imaging information from a medical scanner to an output file, and for simulating/evaluating s...
Surgical Devices·4 affected·Jun 4, 2021
High RiskFDA
Ge Healthcare, Llc
SIGNA Premier - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio...
Medical Devices·100 affected·Jun 4, 2021
High RiskFDA
Simpleware Product Group, Synopsys Northern Europe
Simpleware ScanIP medical software. For transfer of imaging information from a medical scanner to an output file, and for simulating/eva...
Surgical Devices·6 affected·Jun 4, 2021
High RiskFDA
Ge Healthcare, Llc
SIGNA Artist, Nuclear Magnetic Resonance Imaging System
Medical Devices·562 affected·Jun 4, 2021
High RiskFDA
Ge Healthcare, Llc
SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
Medical Devices·71 affected·Jun 4, 2021
High RiskFDA
Ge Healthcare, Llc
Discovery MR750w 3.0T - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noi...
Medical Devices·585 affected·Jun 4, 2021
High RiskFDA
Ge Healthcare, Llc
1.5T SIGNA HDxt (HD28) MR System, Nuclear Magnetic Resonance Imaging System
Medical Devices·91 affected·Jun 4, 2021
High RiskFDA
Ge Healthcare, Llc
Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System
Medical Devices·40 affected·Jun 4, 2021
CriticalFDA
Baxter Healthcare Corporation
Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009. for the controlled administration of fluids.
Medical Devices·130,135 affected·Jun 4, 2021
CriticalFDA
Eight Medical International Bv
Recirculator 8.0s Disposable Lavage Kit (product code number 8100) , GTIN: 08719992086016. Hyperthermic Perfusion System intended to ra...
Medical Devices·22 affected·Jun 4, 2021
CriticalCPSC
Juvenile Product Stores And Mass Merchandisers Nationwide And Online, Including Walmart And Target Stores And Amazon.com. The 4-in-1 Rock 'n Glide Soothers Were Sold From January 2014 Through December 2020, For About $108. The 2-in-1 Soothe 'n Play Gliders Were Sold From November 2018 Through May 2021, For About $125.
Fisher-Price Recalls 4-in-1 Rock 'n Glide Soothers After Four Infant Deaths; 2-in-1 Soothe 'n Play Gliders Also Recalled
Children's Products·120,000 affected·Jun 3, 2021
RecallCPSC
Online At Kalorik.com, Amazon.com, Walmart.com, Kohls.com, Bedbathandbeyond.com, Qvc.com, Homedepot.com, Macys.com, Bestbuy.com, Acehardware.com And Hammacher.com Between July 2020 And March 2021 For About $400.
Kalorik Recalls Electric Steakhouse Grills Due to Shock Hazard (Recall Alert)
Outdoor & Garden·3,525 affected·Jun 3, 2021
High RiskFDA
Boston Scientific Corporation
Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L331
Cardiac Devices·70,074 affected·Jun 3, 2021
CriticalFDA
Heartware, Inc.
HeartWare HVAD Pump Implant Kit, REF 1125
Medical Implants·4,078 affected·Jun 3, 2021
CriticalFDA
Heartware, Inc.
HeartWare HVAD Pump Implant Kit, REF 1153
Medical Implants·163 affected·Jun 3, 2021
CriticalFDA
Heartware, Inc.
HeartWare HVAD Outflow Graft, REF MCS1725OG
Cardiac Devices·459 affected·Jun 3, 2021
High RiskFDA
Axonics Modulation Technologies, Inc.
BULKAMID, URETHRAL BULKING SYSTEM model # 50050 containing the component: Bulkamid Needle, REF 230651221C, 2 G x 12 am, sterile, CE 0476
Medical Devices·2,702 affected·Jun 3, 2021
CriticalFDA
Heartware, Inc.
HeartWare HVAD Pump Accessories, REF MCS1753AK
Cardiac Devices·76 affected·Jun 3, 2021
High RiskFDA
Boston Scientific Corporation
VALITUDE CRT-P pacemaker, Models: a) U125 b) U128
Cardiac Devices·6,377 affected·Jun 3, 2021
CriticalFDA
Boston Scientific Corporation
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
Medical Devices·3,634 affected·Jun 3, 2021
High RiskFDA
Boston Scientific Corporation
Altrua 2 pacemaker, Models: a) S701 b) S702 c) S722
Cardiac Devices·2,952 affected·Jun 3, 2021
CriticalFDA
Heartware, Inc.
HeartWare HVAD Driveline Extension Cable, REF 100
Cardiac Devices·338 affected·Jun 3, 2021
CriticalFDA
Heartware, Inc.
HeartWare HVAD Pump Implant Kit, REF 1103
Medical Implants·647 affected·Jun 3, 2021