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CriticalFDA
Bright Farms
BrightFarms Butter Crisp; packaged in clear, plastic clamshells; 4oz; grown at the company's Rochelle, Illinois indoor farm
Dairy·0 affected·Jul 15, 2021
CriticalFDA
Bright Farms
BrightFarms Harvest Crunch; packaged in clear plastic clamshells; 4oz; grown at the company's Rochelle, Illinois indoor farm
Food·0 affected·Jul 15, 2021
CriticalFDA
Bright Farms
BrightFarms Spring Mix; packaged in clear, plastic clamshells; 4oz and 8oz; grown at the company's Rochelle, Illinois indoor farm
Food·0 affected·Jul 15, 2021
CriticalFDA
Bright Farms
BrightFarms Spinach; packaged in clear, plastic clamshells; 4oz and 8oz; grown at the company's Rochelle, Illinois indoor farm
Produce·0 affected·Jul 15, 2021
CriticalFDA
Bright Farms
BrightFarms Lakeside Crunch; packaged in clear, plastic clamshell; 4oz; grown at the company's Rochelle, Illinois indoor farm
Food·0 affected·Jul 15, 2021
CriticalFDA
Bright Farms
BrightFarms 50/50 Spring & Spinach; packaged in clear plastic clamshells, 4oz; grown at the company's Rochelle, Illinois indoor farm
Produce·0 affected·Jul 15, 2021
CriticalFDA
Johnson & Johnson Consumer, Inc.
Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 50, Avobenzone (3%), Homosalate (10%), Octisalate (5%), ...
Inhaled / Nasal Drugs·1,437,804 affected·Jul 14, 2021
CriticalFDA
Qikmoov Llc
Vy&Tea (Vietnamese Labeling with a green leaf and a bird underneath) 15/KLT 45.0G (15 tea sachets per box), Manufactured by Havyco No. 45...
Drugs·591 affected·Jul 14, 2021
CriticalFDA
Johnson & Johnson Consumer, Inc.
Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 60+, Avobenzone (3%), Homosalate (10%), Octisalate (5%),...
Inhaled / Nasal Drugs·387,648 affected·Jul 14, 2021
CriticalFDA
Micro Therapeutics Inc,
EV3 Pipeline Flex Embolization Device with Flex Shield Technology
Medical Devices·16,169 affected·Jul 13, 2021
CriticalFDA
Baxter Healthcare Corporation
Dose IQ Safety Software used with Spectrum IQ Infusion Pump
Medical Devices·61 affected·Jul 7, 2021
CriticalFDA
Lsg Sky Chefs
Circle K Chicken Salad Sandwich, 5.9 oz. (167g) clamshell packaging with tamper strip, UPC 815138013996, Manufactured By: LSG Sky Chefs S...
Meat & Poultry·42,325 affected·Jul 5, 2021
CriticalFDA
Eillien's Candies, Inc.
Blain's Farm & Fleet Select Dark Chocolate Amaretto Pecans, 12oz.
Snacks & Candy·102 affected·Jul 2, 2021
CriticalFDA
Kvk-tech, Inc.
Atovaquone Oral Suspension, USP, 750 mg/5 mL, 210 mL bottle, Rx Only, Mfd. By: KVK-Tech, Inc., Newtown, PA 18940, NDC 10702-223-21.
Oral Drugs·1,692 affected·Jul 2, 2021
CriticalFDA
H & H Products Company
Hartley's brand Worcestershire sauce in 1 gallon plastic bottles and 50 gallon drums.
Food·1 affected·Jun 23, 2021
CriticalFDA
Ardil Comercial S.r.l.
Limar Hand Sanitizer, Isopropyl Alcohol 70%, Cont. 4 oz bottles, Manufactured in Dominican Republic: by Ardil Comercial S.R.L., Santo Dom...
Drugs·1,260 affected·Jun 22, 2021
CriticalFDA
Eat Gangster, Llc
Eat GANGSTER, Oatmeal Schmoatmeal Cookie Mix, 8.5 Oz, Eat GANGSTER LLC, Wichita, KS, UPC 0 51497 13952 0
Bakery & Grains·330 affected·Jun 21, 2021
CriticalFDA
Prairie Wolf Spirits
Prairie Wolf Distillery Alcohol Antiseptic 80%, Topical Solution Hand Sanitizer, packaged in a) (16.9oz) 500 mL (UPC 8 60003 31899 7, NDC...
Topical Drugs·0 affected·Jun 21, 2021
CriticalFDA
Teva Pharmaceuticals Usa
Topotecan Injection 4 mg/4mL (1 mg/mL), Single-Dose vial, Teva Pharmaceuticals USA, Inc. North Whales, PA 19454, Carton NDC# 0703-4714-01...
Injectable Drugs·10,425 affected·Jun 18, 2021
CriticalFDA
Respironics California, Llc
Philips Respironics V60 Plus Ventilator with Software Versions 3.00 and 3.10. The Respironics V60/V60 Plus Ventilator is an assist ven...
Respiratory Devices·60 affected·Jun 18, 2021
CriticalFDA
Cardinal Health 200, Llc
Argyle UVC Insertion Tray containing Safety Scalpel N11 (vendor part number 73-1811). Intended for use to insert an Umbilical Venous Cat...
Surgical Devices·7,197 affected·Jun 16, 2021
CriticalFDA
Designed By Nature Llc
Designed by Nature Cow's Milk Formula: 12 oz. plastic pouch. Easy to Digest, Nutritionally Alive, Developed for All Life Stages. For...
Dairy·171 affected·Jun 14, 2021
CriticalFDA
Designed By Nature Llc
Designed by Nature Goat's Milk Formula: Easy to Digest, Nutritionally Alive, Developed for All Life Stages. For the Little Ones in Yo...
Dairy·1,688 affected·Jun 14, 2021
CriticalFDA
Designed By Nature Llc
Designed by Nature Base Mix Formula: .375 oz/11 g plastic pouch/ Easy to Digest, Nutritionally Alive, Developed for All Life Stages. F...
Baby Food & Formula·0 affected·Jun 14, 2021
CriticalFDA
Philips Respironics, Inc.
Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators.
Respiratory Devices·255,810 affected·Jun 14, 2021
CriticalFDA
Philips Respironics, Inc.
A-Series BiPAP A 40, A-Series BiPAP A30 Continuous Ventilator, Non-life Supporting
Respiratory Devices·72,665 affected·Jun 14, 2021
CriticalFDA
Arjohuntleigh Polska Sp. Z.o.o.
Arjo Citadel beds originally assembled with the IndiGo modules during manufcturing, model number CX812A3J3AMAD0; and IndiGo modules (retr...
Medical Devices·367 affected·Jun 10, 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
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
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
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
CriticalFDA
Heartware, Inc.
HeartWare HVAD Pump Accessories, REF MCS1753AK
Cardiac Devices·76 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
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
CriticalFDA
Heartware, Inc.
HeartWare HVAD Pump Implant Kit, REF 1104
Medical Implants·943 affected·Jun 3, 2021
CriticalFDA
Heartware, Inc.
HeartWare HVAD Implant Kit, REF 1104JP
Medical Implants·63 affected·Jun 3, 2021
CriticalFDA
Boston Scientific Corporation
INTUA CRT-P, Model Numbers: a) V272 b) V273 c) W273
Medical Devices·1,707 affected·Jun 3, 2021
CriticalFDA
Boston Scientific Corporation
INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)
Cardiac Devices·40,224 affected·Jun 3, 2021
CriticalFDA
Savor Brands Llc.
Farro, Fully Cooked Net Wt. 24 lbs, Item # 641901
Food·1,138 affected·Jun 2, 2021
CriticalFDA
Banner Smoked Fish Inc.
Banner Smoked Fish Inc. brand Sliced Gravlax (Salmon (fish), Salt, Sugar, Dill, Pepper, Sodium Nitrite)
Seafood·0 affected·Jun 1, 2021
CriticalFDA
Banner Smoked Fish Inc.
Banner Smoked Fish Inc. brand Sliced Gravad Lox (Salmon, Salt, Dill weed, Pepper, Natural Hardwood Smoke, Sodium Nitrite)
Seafood·0 affected·Jun 1, 2021