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High RiskFDA
Inpeco S.a.
Accelerator a3600 Automation System with the Aliquoter Module (Inpeco P/N FLX-212) The FlexLab (aka Accelerator a3600 and Aptio Autom...
Medical Devices·136 affected·Jul 14, 2020
High RiskFDA
Olympus Corporation Of The Americas
Smart Stapes Protheses Piston 0.6mm X 4.25 mm- Partial Ossicular Replacement Catalog Number: 70143662
Medical Devices·21 affected·Jul 14, 2020
High RiskFDA
Inpeco S.a.
Aptio Automation System with the Aliquoter Module (Inpeco P/N FLX-212) The FlexLab (aka Accelerator a3600 and Aptio Automation) is a ...
Medical Devices·104 affected·Jul 14, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc
Cios Alpha (VA20) - Model: 10308191 Cios Alpha (VA30) - Model: 11105200 Cios Spin (VA30) - Model: 10308194 Cios Alpha and Cios Spin...
Medical Devices·282 affected·Jul 14, 2020
High RiskFDA
Thomas Scientific
Wuxi Nest, model numbers 202115, 202117, 202017, 202018 - Product Usage: Patient specimen collection.
Medical Devices·115,800 affected·Jul 14, 2020
High RiskFDA
Flagstone Foods Llc
Wegmans PECAN BLEND Supreme Pecans, Cashews & Pistachios NET WT 16 OZ(1 LB) 454g plastic bag Ingredients: Pecans, Cashews, Dry Roasted Pi...
Food·280 affected·Jul 13, 2020
RecallFDA
Lopez Gonzalez Santana Corporation
BTREX PLUS, Dietary Supplement 2 Caplets, UPC 05380930802 (Physician Samples)
Supplements·32,179 affected·Jul 13, 2020
High RiskFDA
Siam Trading Inc.
Khaotan Rice Cracker, Net Wt. 150g
Bakery & Grains·50 affected·Jul 13, 2020
High RiskFDA
Bausch Health Companies, Inc.
Hydrocortisone butyrate Cream, 0.1%, 15-gram tubes, Rx Only, Manufactured for Oceanside Pharmaceuticals a division of Valeant Pharmaceuti...
Topical Drugs·35,424 affected·Jul 13, 2020
RecallFDA
Fresenius Kabi Usa, Llc
Fosaprepitant for Injection, 150 mg / vial in a 10 mL Single-Dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047; NDC 63323-972-10
Injectable Drugs·63,067 affected·Jul 13, 2020
High RiskFDA
Ortho-clinical Diagnostics
VITROS XT Chemistry Products TBIL-ALKP Slides (ALKP is not affected) In Vitro Diagnostic use only - The TBIL test within the VITROS XT Ch...
Diagnostic Devices·4,076 affected·Jul 13, 2020
RecallFDA
Orasure Technologies, Inc.
Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 2 plate Matrix Oral Fluid Coated Micro-Plate. IVD Immunoassay for ...
Diagnostic Devices·13 affected·Jul 13, 2020
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products TBIL Slides- 5 PACK/300 SLDS In vitro Diagnostic quantitatively measure total bilirubin (TBIL) concentration i...
Diagnostic Devices·149,370 affected·Jul 13, 2020
High RiskFDA
4e Brands North America, Llc
Modesa instant HAND SANITIZER with moisturizers & vitamin E, (70% ethyl alcohol), 33.8 FL OZ (1 L) bottle, Distributed by Greenbrier Inte...
Supplements·17,359,247 affected·Jul 11, 2020
High RiskFDA
4e Brands North America, Llc
ASSURED Instant Hand Sanitizer Vitamin E and Aloe, (70% ethyl alcohol), Packaged as a) 8 fL oz / 236 ml bottle, UPC 6 39277 49069 8 b) 10...
Supplements·17,359,247 affected·Jul 11, 2020
High RiskFDA
4e Brands North America, Llc
blumen Clear ADVANCED HAND SANITIZER with 70% ALCOHOL, (ethyl alcohol 70% v/v), Packaged as a) 2 fl oz / 60 ml bottle, UPC 8 14266 02371 ...
Drugs·17,359,247 affected·Jul 11, 2020
High RiskFDA
4e Brands North America, Llc
ASSURED Instant Hand Sanitizer Aloe & Moisturizers, (70% ethyl alcohol), Packaged as a) 8 fL oz / 236 ml bottle, UPC 6 39277 49070 4 b) ...
Drugs·17,359,247 affected·Jul 11, 2020
High RiskFDA
4e Brands North America, Llc
blumen ADVANCED HAND SANITIZER, 70% ALCOHOL CONTENT, (70% ethyl alcohol), packaged as a) 3.4 fl oz / 100 ml bottle, UPC 8 14266 02359 4 b...
Drugs·17,359,247 affected·Jul 11, 2020
CriticalFDA
4e Brands North America, Llc
blumen Clear ADVANCED HAND SANITIZER with 70% ALCOHOL, (ethyl alcohol 70% v/v), Packaged as a) 2 fl oz / 60 ml bottle, UPC 8 14266 02371 ...
Drugs·17,359,247 affected·Jul 11, 2020
CriticalFDA
4e Brands North America, Llc
blumen ADVANCED INSTANT HAND SANITIZER Clear ETHYL ALCOHOL 70% natural boost with tea tree oil (70% ethyl alcohol), 33.8 fl oz / 1 L bott...
Drugs·0 affected·Jul 11, 2020
High RiskFDA
4e Brands North America, Llc
blumen Aloe ADVANCED HAND SANITIZER 70% ALCOHOL CONTENT (70% ethyl alcohol v/v), 3.4 fl. oz./100 mL bottle, Distributed in USA and Canada...
Drugs·17,359,247 affected·Jul 11, 2020
High RiskFDA
4e Brands North America, Llc
blumen ADVANCED INSTANT HAND SANITIZER Clear ETHYL ALCOHOL 70% Natural Boost with Tea Tree Oil, (70% ethyl alcohol), Packaged as a) 18 fl...
Drugs·17,359,247 affected·Jul 11, 2020
CriticalFDA
4e Brands North America, Llc
blumen ADVANCED HAND SANITIZER 70% ALCOHOL CONTENT, (ethyl alcohol 70% v/v) Packaged as a) 3.4 fl oz / 100 ml bottle, UPC 8 14266 02359 4...
Drugs·17,359,247 affected·Jul 11, 2020
High RiskFDA
Keryx Biopharmaceuticals, Inc.
Auryxia (ferric citrate) tablets 210 mg, Rx Only, 200 tablets per bottle, Manufactured for and distributed by: Keryx Biopharmaceuticals, ...
Oral Drugs·59,820 affected·Jul 10, 2020
High RiskFDA
Randox Laboratories, Ltd.
Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 Reagent
Diagnostic Devices·1,497 affected·Jul 10, 2020
RecallCPSC
Anandaessentialoils.com From July 2019 Through February 2020 Between $2 And $100.
Ananda Apothecary Recalls Essential Oils Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning (Recall Alert)
Children's Products·275 affected·Jul 9, 2020
RecallCPSC
Direct To Customers And Through Distributors, Agents And Resellers Nationwide From January 2016 Through May 2019 For Between $4,000 And $5,000.
Cooper Lighting Recalls Light Fixtures Due to Injury Hazard (Recall Alert)
Lighting·39,000 affected·Jul 9, 2020
RecallCPSC
Online At Amazon.com, Buybuybaby.com, Target.com,jcpenney.com And Other Online Retailers From August 2018 Through September 2019 For About $110.
DaVinci Recalls Bassinets Due to Fall and Entrapment Hazards (Recall Alert)
Children's Products·3,000 affected·Jul 9, 2020
RecallCPSC
Online At Miraclebotanicals.com, Amazon.com And Etsy.com From July 2016 Through April 2020 For Between $8 And $19.
Miracle Botanicals Recalls Wintergreen and Birch Essential Oils Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning (Recall Alert)
Children's Products·380 affected·Jul 9, 2020
CriticalCPSC
Rh Galleries And Rh Outlets Nationwide And Online At Www.restorationhardware.com From November 2012 Through March 2019 For Between $83 And $825.
RH Recalls Riveted Mesh Floor Lamps Due to Fire Hazard (Recall Alert)
Lighting·1,180 affected·Jul 9, 2020
High RiskFDA
Maquiladora Miniara Sa De Cv
Shine & Clean Hand Sanitizer gel, (Ethyl Alcohol 70%), 33.81 fl oz (1L) bottle, Made in Mexico By: Maquiladora Miniara S.A. de C.V. Carre...
Topical Drugs·245,500 affected·Jul 9, 2020
High RiskFDA
Mako Surgical Corporation
Mako Hip End Effector, Variable Angle Catalog Number: 206967 GTIN:00848486022167
Medical Devices·12 affected·Jul 9, 2020
RecallCPSC
Online At Glorybee.com And At Specialty And Health Food Stores Nationwide From October 2016 Through August 2019 For Between $4 And $57.
GloryBee Natural Sweeteners Recalls GloryBee Wintergreen Essential Oil Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning
Children's Products·540 affected·Jul 8, 2020
RecallCPSC
Lidl Us Stores In Virginia, North Carolina, South Carolina, Maryland, Georgia, Delaware, Pennsylvania, New Jersey, And New York And Online At Www.lidl.com From March 2018 Through May 2020 For Between $24 And $70
Lidl US Recalls Silvercrest Bread Makers Due to Electric Shock Hazard
Consumer Products·1,840 affected·Jul 8, 2020
RecallCPSC
Small, Independent Grocery Stores And Food Cooperatives Nationwide, And Online At Www.rosemarygarden.com From June 2018 Through April 2020 For About $7.
Pranarom Recalls Wintergreen Essential Oils Due to Failure to Meet Child Resistant Packaging Requirements; Risk of Poisoning
Children's Products·960 affected·Jul 8, 2020
High RiskFDA
Flower Orthopedics Corporation
Calcaneus Plate, Extensile, Medium, Left, Catalog Number CPF 102 - Product Usage: intended to be used for internal fixation of fractures ...
Medical Devices·25 affected·Jul 8, 2020
High RiskFDA
New Wave Endo-surgical, Corp.
M-Close Kit, REF 27-101; a disposable, ligature passing, suturing apparatus and needle guide for the abdominal wall
Medical Devices·295 affected·Jul 8, 2020
High RiskFDA
Flower Orthopedics Corporation
Calcaneus Plate, Extensile, Large, Right, Catalog Number CPF 203 - Product Usage: intended to be used for internal fixation of fractures ...
Medical Devices·25 affected·Jul 8, 2020
High RiskFDA
Flower Orthopedics Corporation
Calcaneus Plate, Extensile, Small, Right, Catalog Number CPF 201 - Product Usage: intended to be used for internal fixation of fractures ...
Medical Devices·25 affected·Jul 8, 2020
RecallUSDA
Brucepac
FSIS Issues Public Health Alert for Ready-To-Eat Diced Chicken Products Due to Misbranding and an Undeclared Allergen
Poultry·0 affected·Jul 8, 2020
High RiskFDA
Kind Llc
***KIND HEALTHY GRAINS***Oats & Honey Granola with Toasted Coconut***INGREDIENTS: Oats, tapioca syrup, brown rice, cane sugar, honey, mil...
Bakery & Grains·142,273 affected·Jul 7, 2020
High RiskFDA
Lupin Pharmaceuticals Inc.
Metformin Hydrochloride Extended-release Tablets USP 500 mg, 100 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., M...
Oral Drugs·64,344 affected·Jul 7, 2020
CriticalFDA
Carefusion 213, Llc
ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution - Hi-Lite Orange, 0.10...
Drugs·36 affected·Jul 7, 2020
High RiskFDA
Lupin Pharmaceuticals Inc.
Metformin Hydrochloride Extended-Release Tablets USP 1000 mg, 60 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., M...
Oral Drugs·273,060 affected·Jul 7, 2020
High RiskFDA
Lupin Pharmaceuticals Inc.
Metformin Hydrochloride Extended-Release Tablets USP 500 mg, 60 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Ma...
Oral Drugs·59,568 affected·Jul 7, 2020
CriticalFDA
Mylan Institutional Llc
Daptomycin for Injection, 500 mg/vial, Single-Dose Vial, Rx only, Sterile, Manufactured for: Mylan Institutional, LLC, Rockford, IL 61103...
Injectable Drugs·18,480 affected·Jul 7, 2020
CriticalFDA
Carefusion 213, Llc
BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.10 fl. oz. (3 ml) each,...
Drugs·988 affected·Jul 7, 2020
CriticalFDA
Carefusion 213, Llc
BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Sterile Solution, 0.01 fl. oz. (3 ...
Drugs·400 affected·Jul 7, 2020