Skip to main content
CriticalFDA
Whole Foods Market
Marble Bundt Cake sold by the slice packaged in Self Serve and Plastic clam shell containers PLU 45162
Bakery & Grains·241 affected·Feb 4, 2020
CriticalFDA
Whole Foods Market
Chocolate Fudge Mini Bundt Cake sold by the slice packaged in Self Serve and Plastic clam shell containers PLU 21287
Bakery & Grains·241 affected·Feb 4, 2020
CriticalFDA
Carefusion 303, Inc.
CareFusion Alaris System, Alaris PC unit models 8000 and 8015 (UDI: 10885403801518)
Medical Devices·870,070 affected·Feb 4, 2020
CriticalFDA
Carefusion 303, Inc.
CareFusion Alaris PCA Module, Model 8120
Medical Devices·83,015 affected·Feb 4, 2020
High RiskFDA
Deroyal Industries, Inc. Lafollette
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC Thyroid Pack 89-6302.14
Medical Devices·2,100 affected·Feb 4, 2020
CriticalFDA
Carefusion 303, Inc.
CareFusion Alaris Pump Module, Model 8100
Medical Devices·1,286,898 affected·Feb 4, 2020
CriticalFDA
Carefusion 303, Inc.
CareFusion Alaris Syringe Module, Model 8110
Medical Devices·114,835 affected·Feb 4, 2020
High RiskFDA
Deroyal Industries, Inc. Lafollette
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC Ocular Plastics Pack 89-6498.13
Medical Devices·2,100 affected·Feb 4, 2020
High RiskFDA
Deroyal Industries, Inc. Lafollette
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Shoulder Pack 89-4751.08
Medical Devices·2,100 affected·Feb 4, 2020
High RiskFDA
Deroyal Industries, Inc. Lafollette
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Outpatient Major 89-3865.12;
Medical Devices·2,100 affected·Feb 4, 2020
High RiskFDA
Deroyal Industries, Inc. Lafollette
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Cystoscopy Pack 89-6071.15
Medical Devices·2,100 affected·Feb 4, 2020
High RiskFDA
Deroyal Industries, Inc. Lafollette
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC General Pack 89-6015.16
Medical Devices·2,100 affected·Feb 4, 2020
High RiskFDA
Deroyal Industries, Inc. Lafollette
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Ophthalmology CSTM PCK 89-6387.08
Medical Devices·2,100 affected·Feb 4, 2020
High RiskFDA
Contract Pharmacal Corporation
Major Extra Strength Acetaminophen Tablets, 500 mg Pain Reliever/Fever Reducer, packaged in a) 100-count bottles (NDC 0904-6730-60; UPC 3...
Oral Drugs·1,176 affected·Feb 3, 2020
High RiskFDA
Contract Pharmacal Corporation
Leader Extra Strength Acetaminophen Tablets, 500 mg Pain Reliever/Fever Reducer,100-count bottles,Distributed by Cardinal Health, Dublin ...
Oral Drugs·5,472 affected·Feb 3, 2020
High RiskFDA
Pfizer Inc.
Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL), 2 mL Single-dose Vial, Each Tray contains 25 Vials, Intravenous or Intramus...
Injectable Drugs·38,676 affected·Feb 3, 2020
High RiskFDA
Dexcom Inc
Dexcom G6 Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monitoring dev...
Diabetes Devices·275,583 affected·Feb 3, 2020
High RiskFDA
Materialise N.v.
TRUMATCH Orthognathic - Full Bimaxillary Surgical Kit, Catalog Number SD980.001
Surgical Devices·1 affected·Feb 3, 2020
High RiskFDA
Radiometer Medical Aps
ABL90 FLEX PLUS Analyzer, Model Number 393-092 - Product Usage: It is intended for use in a laboratory environment, near patient or point...
Medical Devices·3,968 affected·Feb 3, 2020
High RiskFDA
Dexcom Inc
Dexcom G4 PLATINUM Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monit...
Diabetes Devices·3,091 affected·Feb 3, 2020
High RiskFDA
Radiometer Medical Aps
ABL90 FLEX Analyzer, Model Numbers 393-090, with software versions below 3.4MR2 - Product Usage: It is intended for use in a laboratory e...
Medical Devices·12,822 affected·Feb 3, 2020
High RiskFDA
Dexcom Inc
Dexcom G5 Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monitoring dev...
Diabetes Devices·85,529 affected·Feb 3, 2020
High RiskFDA
Materialise N.v.
TRUMATCH Orthognathics - Genioplasty Surgical Kit, Add-on, Catalog Number: SD980.013
Surgical Devices·1 affected·Feb 3, 2020
High RiskFDA
Efficient Laboratories, Inc.
New! Rompe Pecho MAX Multi Symptoms, 8 FL. Oz (237 mL) bottle, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166. UPC 0 00856 ...
Drugs·4,080 affected·Jan 31, 2020
High RiskFDA
Efficient Laboratories, Inc.
Rompe Pecho EX Expectorant, 6 FL. Oz (178 mL) bottle, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166. UPC 0 00856 30106 1
Drugs·5,387 affected·Jan 31, 2020
High RiskFDA
Efficient Laboratories, Inc.
Rompe Pecho CF Cold & Flu with Honey, 6 FL. Oz (178 mL) bottle, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166.UPC 0 00856 ...
Drugs·5,249 affected·Jan 31, 2020
High RiskFDA
Zydus Pharmaceuticals Usa Inc
Ethacrynate Sodium for Injection, USP, 50mg/vial, Single Dose Vial, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India...
Injectable Drugs·2,207 affected·Jan 31, 2020
High RiskFDA
Applied Medical Resources Corp
STEALTH SPRING CLIP 6mm latis (3/4 Force). REF/UDI::A1603/(01)00607915110581 - Product Usage: The device is indicated for surgical clampi...
Surgical Devices·2,240 affected·Jan 31, 2020
High RiskFDA
89 North
LDI Laser firmware lower than V02.13.00 for LDI models: LDl-7, LDI-WF, LDI-NIR, LDl-6 Laser Science fluorescence imaging
Medical Devices·188 affected·Jan 31, 2020
High RiskFDA
Applied Medical Resources Corp
STEALTH SPRING CLIP 6mm latis (1/4 Force). REF/UDI::A1602/(01)00607915110574 - Product Usage: The device is indicated for surgical clampi...
Surgical Devices·2,240 affected·Jan 31, 2020
High RiskFDA
Cardinal Health 200, Llc
Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January...
Surgical Devices·2,161,526 affected·Jan 31, 2020
High RiskFDA
Applied Medical Resources Corp
STEALTH SPRING CLIP 6mm latis (1/2 Force). REF/UDI::A1601/(01)00607915110567 - Product Usage: The device is indicated for surgical clampi...
Surgical Devices·2,240 affected·Jan 31, 2020
High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Medtronic CareLink 2090 Programmer. Used to interrogate and program Medtronic and Vitatron implantable devices, such as pacemaker/ICD/CRT.
Medical Implants·23,180 affected·Jan 30, 2020
High RiskFDA
Organ Recovery Systems, Inc.
LKT200 Perfusion Circuit, part of Lifeport Kidney Perfusion Transporter KTR - Product Usage: The circuit is an accessory to LifePort Kidn...
Medical Devices·2,274 affected·Jan 30, 2020
CriticalFDA
Bakkavor Foods Usa Inc.
chef's recipe MUSHROOM BARLEY SOUP NET WT 16 OZ (1LB) 454g PROUDLY DISTRIBUTED BY: HARRIS TEETER, LLC, MATTHEWS, NC 28105 UPC 1 61088 803...
Food·840 affected·Jan 29, 2020
CriticalFDA
Salud Natural Entrepreneur, Inc.
Nopalina Flax Seed Fiber in 1 and 2 lb bags, UPC 8 90523 00072 0 and 8 90523 00084 3
Food·20,511 affected·Jan 29, 2020
CriticalFDA
Salud Natural Entrepreneur, Inc.
Nopalina Flax Seed Fiber Capsules, 120 count bottle, UPC 8 90523 00086 7
Food·7,111 affected·Jan 29, 2020
High RiskFDA
Unichem Pharmaceuticals Usa Inc
Clonidine Hydrochloride Tablets, USP 0.1mg, Rx Only, 100-count bottle, Manufactured by: Unichem Laboratories Ltd. Pilerne Ind. Estate, Pi...
Oral Drugs·19,161,600 affected·Jan 29, 2020
CriticalFDA
Abbott Vascular
NC TRAVELER Coronary Dilatation Catheter, REF 1013157-15, Rx Only,NC Traveler RX 4.0 X 15MM The NC Traveler RX Coronary Dilatation Ca...
Surgical Devices·791 affected·Jan 29, 2020
CriticalFDA
Abbott Vascular
NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.50 X 8MM BDC The NC TREK RX Coronary Dilatation Catheter i...
Medical Implants·39,687 affected·Jan 29, 2020
High RiskFDA
Beckman Coulter Inc.
ISE Electrolyte Reference (2 X 2L) Reagent, REF A28937, UDI: 15099590202491 - Product Usage: are intended for the quantitative determinat...
Diagnostic Devices·2,738 affected·Jan 29, 2020
CriticalFDA
Abbott Vascular
NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.50 X 8MM BDC The NC TREK RX Coronary Dilatation Catheter is...
Medical Implants·39,687 affected·Jan 29, 2020
CriticalFDA
Abbott Vascular
NC TRAVELER Coronary Dilatation Catheter, REF 1013158-08, Rx Only,NC Traveler RX 4.5 X 8MM The NC Traveler RX Coronary Dilatation Cat...
Surgical Devices·791 affected·Jan 29, 2020
High RiskFDA
Inova Lasers Llc
Class IV New Era medical laser device
Medical Devices·8 affected·Jan 29, 2020
CriticalFDA
Abbott Vascular
NC TRAVELER Coronary Dilatation Catheter, REF 1013157-12, Rx Only,NC Traveler RX 4.0 X 12MM The NC Traveler RX Coronary Dilatation Ca...
Surgical Devices·791 affected·Jan 29, 2020
CriticalFDA
Abbott Vascular
NC TREK Coronary Dilatation Catheter, REF 1012455-08 Rx Only, NC TREK RX 5.00 X 8MM BDC The NC TREK RX Coronary Dilatation Catheter i...
Medical Implants·39,687 affected·Jan 29, 2020
CriticalFDA
Abbott Vascular
NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.00 X 20MM BDC The NC TREK RX Coronary Dilatation Catheter ...
Medical Implants·39,687 affected·Jan 29, 2020
CriticalFDA
Abbott Vascular
NC TREK Coronary Dilatation Catheter, REF 1012454-15 Rx Only, NC TREK RX 4.50 X 15MM BDC The NC TREK RX Coronary Dilatation Catheter ...
Medical Implants·39,687 affected·Jan 29, 2020