Browse
All Product Recalls
49,209 recalls (high severity)
High RiskFDA
Deroyal Industries, Inc. Lafollette
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Cystoscopy Pack 89-6071.15
Medical Devices2,100 affectedFeb 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 Devices2,100 affectedFeb 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 Devices2,100 affectedFeb 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 Drugs1,176 affectedFeb 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 Drugs5,472 affectedFeb 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 Drugs38,676 affectedFeb 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 Devices275,583 affectedFeb 3, 2020
High RiskFDA
Materialise N.v.
TRUMATCH Orthognathic - Full Bimaxillary Surgical Kit, Catalog Number SD980.001
Surgical Devices1 affectedFeb 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 Devices3,968 affectedFeb 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 Devices3,091 affectedFeb 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 Devices12,822 affectedFeb 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 Devices85,529 affectedFeb 3, 2020
High RiskFDA
Materialise N.v.
TRUMATCH Orthognathics - Genioplasty Surgical Kit, Add-on, Catalog Number: SD980.013
Surgical Devices1 affectedFeb 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 ...
Drugs4,080 affectedJan 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
Drugs5,387 affectedJan 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 ...
Drugs5,249 affectedJan 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 Drugs2,207 affectedJan 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 Devices2,240 affectedJan 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 Devices188 affectedJan 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 Devices2,240 affectedJan 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 Devices2,161,526 affectedJan 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 Devices2,240 affectedJan 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 Implants23,180 affectedJan 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 Devices2,274 affectedJan 30, 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 Drugs19,161,600 affectedJan 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 Devices2,738 affectedJan 29, 2020
High RiskFDA
Inova Lasers Llc
Class IV New Era medical laser device
Medical Devices8 affectedJan 29, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Honeywell Pressure Transducer- Part Number: 370506-22. It is a component used in 2008T, Common Name: Hemodialysis Delivery System; 2008T ...
Medical Devices3,561 affectedJan 29, 2020
High RiskFDA
Southern Sisters Gourmet
Southern Sisters Gourmet Cheddar Garlic Biscuits, Net Wt 16 oz (453.6 g)
Food0 affectedJan 28, 2020
High RiskFDA
Southern Sisters Gourmet
Southern Sisters Gourmet Apple Crisp mix
Food0 affectedJan 28, 2020
High RiskFDA
Southern Sisters Gourmet
Southern Sisters Gourmet Butter Pecan Cheeseball mix, Net Wt 358.919 g, 16 servings
Dairy0 affectedJan 28, 2020
High RiskFDA
Southern Sisters Gourmet
Southern Sisters Gourmet Shrimp and Stone-Ground Grits, Seasoning - Net Wt: 12 g, Grits - Wt: 8 ounces
Seafood0 affectedJan 28, 2020
High RiskFDA
Il Nuts
Yossef Roasting Co. Handcrafted Nuts Watermelon Seeds; 7oz.
Beverages50 affectedJan 28, 2020
High RiskFDA
Southern Sisters Gourmet
Southern Sisters Gourmet Taco Soup, Net Wt- Pkg 1: 191.65 g, Pkg 2: 8 ounces
Food0 affectedJan 28, 2020
High RiskFDA
Southern Sisters Gourmet
Southern Sisters Gourmet Crab Cake Mix, Net Wt 96 g (3.38 oz)
Seafood0 affectedJan 28, 2020
High RiskFDA
Southern Sisters Gourmet
Southern Sisters Gourmet Oven Fried Chicken, Net Wt 2.6 oz/75.6 g
Meat & Poultry0 affectedJan 28, 2020
High RiskFDA
Ncs Healthcare Of Kentucky Inc
Glycopyrrolate Tabs, USP, 1 mg, 30-count unit dose blister card, FOR INSTITUTIONAL USE ONLY, Rx Only, Packaged by Vangard, Glasgow, KY 42...
Drugs6,929 affectedJan 28, 2020
High RiskFDA
Teva Pharmaceuticals Usa
Tramadol Hydrochloride Tablets USP CIV, 50 mg, packaged in a) 100-count bottles (NDC 0093-0058-01), b) 500-count bottles (NDC 0093-0058-...
Injectable Drugs2,044,497 affectedJan 28, 2020
High RiskFDA
B And A Trading Corporation
Kushim Tablets (Gushim) 45-count packages, Label in foreign language
Oral Drugs40 affectedJan 28, 2020
High RiskFDA
Graviti Pharmaceuticals Private Limited
Atorvastatin Calcium Tablets, USP, 10 mg*, 90-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009 USA; Man...
Oral Drugs29,056 affectedJan 28, 2020
High RiskFDA
Breas Medical, Inc.
Protective Cover Vivo 55/65 (Used for Vivo 50/65), Part No. 006344. It is an accessory (i.e. protective cover) for the Vivo 50 and Vivo 6...
Respiratory Devices629 affectedJan 28, 2020
High RiskFDA
Smith & Nephew, Inc.
JOURNEY II UNI RESECTION PREP TRIAL, LEFT MEDIAL/ RIGHT LATERAL - Product Usage: The JOURNEY II Uni Resection Prep Trial is a reusable su...
Surgical Devices200 affectedJan 28, 2020
High RiskFDA
Medtronic, Plc
McGRATH X3 Disposable Laryngoscope Blades-used with the McGRATH MAC Video Laryngoscope to aid the intubation of the trachea Code: X3-...
Medical Devices109,897 affectedJan 28, 2020
High RiskFDA
Smith & Nephew, Inc.
JOURNEY II UNI RESECTION PREP TRIAL, RIGHT MEDIAL/ LEFT LATERAL - Product Usage: The JOURNEY II Uni Resection Prep Trial is a reusable su...
Surgical Devices195 affectedJan 28, 2020
High RiskFDA
Medicrea International
Pedicle Screws, multiple sizes, Article Nos. B36004525 B36004530 B36004535 B36004540 B36004545 B36004550 B36004555 B36005530 B...
Medical Devices3,529 affectedJan 28, 2020
High RiskFDA
Qiagen Sciences Llc
QIAGEN Rotor Gene Q Software version 2.3.4. Real-time PCR analyzer designed for rapid thermalcycling and real-time detection of PCR ass...
Diagnostic Devices11,418 affectedJan 28, 2020
High RiskFDA
Teva Pharmaceuticals Usa
Desmopressin Acetate Tablets, 0.1 mg, 100-count bottle, Rx Only, Manufactured by: Actavis Laboratories, Inc. Fort Lauderdale, FL 33314 US...
Oral Drugs22,868 affectedJan 27, 2020
High RiskFDA
Teva Pharmaceuticals Usa
Methylphenidate hydrochloride Extended-Release ablets USP (CII), 27 mg, 100-count bottle, Rx only, Teva Pharmaceuticals USA, Inc., North ...
Drugs17,436 affectedJan 27, 2020