Source

FDA Recalls

The U.S. Food and Drug Administration regulates drugs, medical devices, food, cosmetics, and tobacco products. Recall data here includes pharmaceutical adverse events and drug recalls.

68,659Total Recalls
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68,659 recalls
CriticalFDA
Boston Scientific Corporation
Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 25mm, sterile, REF H749LVSUS250, GTIN 08714...
Medical Implants·319 affected·Nov 17, 2020
CriticalFDA
Boston Scientific Corporation
Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 27mm, sterile, REF H749LVSUS270, GTIN 08714...
Medical Implants·302 affected·Nov 17, 2020
CriticalFDA
Boston Scientific Corporation
Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 27mm, sterile, REF H749LVS270, GTIN 0871472...
Medical Implants·386 affected·Nov 17, 2020
High RiskFDA
Remote Diagnostic Technologies Ltd.
Tempus LS - Manual Defibrillator, Model Number: 00-3020 Software Version: 1.3.4 - Product Usage: The device is intended to be used in th...
Cardiac Devices·175 affected·Nov 17, 2020
CriticalFDA
Boston Scientific Corporation
Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 25mm, sterile, REF H749LVS250, GTIN 0871472...
Medical Implants·278 affected·Nov 17, 2020
CriticalFDA
Fresh Express Incorpated
FRESH EXPRESS KIT CAESAR SUPREME, Romaine Lettuce, Creamy Caesar Dressing, Italian Artisan Cheeses, Savory Garlic Croutons, Total Net WT....
Dairy·4,782 affected·Nov 16, 2020
High RiskFDA
Galt Medical Corporation
Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-002-06 Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-006-16
Surgical Devices·9,920 affected·Nov 16, 2020
High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Medtronic Cobalt DR MRI SureScan DDPB3D1, MR Conditional implantable dual chamber cardioverter defibrillator with SureScan technology and...
Medical Implants·2 affected·Nov 15, 2020
High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Medtronic Cobalt HF CRT-D MRI SureScan DTPB2D1, MR Conditional implantable cardioverter defibrillator with cardiac resynchronization ther...
Medical Implants·2 affected·Nov 15, 2020
RecallFDA
Dole Fresh Vegetables Inc
Presidents Choice Coleslaw 14 oz. plastic bag UPC:0-6038322267-3
Food·249 affected·Nov 14, 2020
CriticalFDA
Kanan Enterprises Inc.
On the Go Sweet & Salty Trail Mix
Food·1,203 affected·Nov 13, 2020
High RiskFDA
The Coca-cola Company
Minute Maid STRAWBERRY LEMONADE FLAVORED WITH OTHER NATURAL FLAVORS 59 FL OZ (1.8 QT) 1.75 L PRODUCED FOR THE COCA-COLA COMPANY ATLANTA, ...
Produce·10,409 affected·Nov 13, 2020
High RiskFDA
The Neil Jones Food Company
Sysco Arrezzio 3/8" Petite Diced Tomatoes in Tomato Puree, #7807458, each metal can has the net weight of 6.38 lbs. (2.89 kg). UPC 7 347...
Produce·104 affected·Nov 13, 2020
High RiskFDA
The Coca-cola Company
Minute Maid WATERMELON FLAVORED FRUIT DRINK WITH OTHER NATURAL FLAVORS 59 FL OZ (1.8 QT) 1.75 L PRODUCED FOR THE COCA-COLA COMPANY ATLANT...
Beverages·6,254 affected·Nov 13, 2020
High RiskFDA
Gt's Living Foods
Synergy raw kombucha - Multi-Green; 16 fl. oz. (473 mL) UPC 7 22430 14016 2 GT's Living Foods LLC Beverly Hills, CA
Beverages·1,113 affected·Nov 13, 2020
CriticalFDA
Boston Scientific Corporation
EMBLEM S-ICD Subcutaneous Electrode Model 3501. Component of implantable cardioverter defibrillator (ICD)
Medical Implants·47,000 affected·Nov 13, 2020
High RiskFDA
Medline Industries Inc
Resect. Intest. Laparo-LF, Model DYNJ42667A - Product Usage: This is a type of convenience kit used in various surgeries including cardia...
Cardiac Devices·88 affected·Nov 13, 2020
High RiskFDA
Medline Industries Inc
Cardiac Pack - LF, Model DYNJ31903I - Product Usage: This is a type of convenience kit used in various surgeries including cardiac, abdom...
Cardiac Devices·360 affected·Nov 13, 2020
High RiskFDA
Randox Laboratories Ltd.
Randox Mg R1 - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urine Catalogue Number: MG3880
Medical Devices·1 affected·Nov 13, 2020
High RiskFDA
Tucson Tamale Wholesale Company, Llc
Tucson Tamale Blue Corn & Veggie Tamales (2 Pack), 11 OZ (312g), plastic bag, UPC 8 53437 00234, Keep Frozen, 6 packs/box (case)
Frozen Food·243 affected·Nov 12, 2020
High RiskFDA
Tucson Tamale Wholesale Company, Llc
Tucson Tamale Blue Corn, Veggie & Cheese Tamales (2 Pack), 11 OZ (312g), plastic bag, UPC 8 53437 00233, Keep Frozen, 6 packs/box (case)
Dairy·129 affected·Nov 12, 2020
High RiskFDA
Medtronic Inc.
CareLink Personal Software Therapy Management Software Tool for Diabetes CareLink System Therapy Management Software Tool for Diabetes ...
Diabetes Devices·46,461 affected·Nov 12, 2020
High RiskFDA
Conmed Corporation
Infinity ACL Tibial Tip Guide- indicated for use in open and arthroscopic procedures for knee ligament reconstruction. Catalog Number: ...
Medical Devices·95 affected·Nov 12, 2020
High RiskFDA
Conmed Corporation
Infinity ACL Tibial Elbow Guide-indicated for use in open and arthroscopic procedures for knee ligament reconstruction. Catalog Number: ...
Medical Devices·73 affected·Nov 12, 2020
High RiskFDA
Medtronic Neuromodulation
Medtronic Intellis Spinal Cord Stimulator, Model Number A710, Clinical Programmer application version 1.3.80 - Product Usage: intended fo...
Medical Implants·7,960 affected·Nov 12, 2020
High RiskFDA
Livanova Usa Inc
VNS Therapy SENTIVA DUO # 1000-D - Product Usage: indicated for the treatment of chronic or recurrent depression in patients who are expe...
Medical Devices·8 affected·Nov 12, 2020
CriticalFDA
Hill-rom Manufacturing, Inc.
Life2000 Ventilation System, including Life2000 Ventilator and Life2000 Compressor, Model MS-01-0118 - Product Usage: use in home and ins...
Respiratory Devices·67 affected·Nov 12, 2020
High RiskFDA
Apotex Corp.
Aripiprazole Tablets, USP 15 mg tablets, packaged in a) 1000 count bottle, NDC 60505-2675-8; b) 30 count bottle, NDC 60505-2675-3; Rx Onl...
Oral Drugs·552 affected·Nov 11, 2020
RecallFDA
Teva Pharmaceuticals Usa
Testosterone Gel 1%, 2.5 grams per unit dose, packaged in 2.5 gram Unit-Dose Packets (NDC 0591-3216-17); 30 Unit-Dose Packets per carton ...
Topical Drugs·12,088 affected·Nov 11, 2020
RecallFDA
Invatech Pharma Solutions, Llc
Levocetirizine Dihydrochloride Tablets, USP, 5 mg 30-count bottle, Rx Only, Distributed by: Marlex Pharmceuticals, Inc. New Castle, DE 1...
Oral Drugs·0 affected·Nov 11, 2020
High RiskFDA
Integra Lifesciences Corp.
Instruction Manual for Mayfield A2000 Skull Cap - Product Usage: intended for or rigid skeletal fixation during neurosurgical procedures....
Surgical Devices·552 affected·Nov 11, 2020
High RiskFDA
Terumo Cardiovascular Systems Corporation
(1) Capiox FX25 (West) Advance Oxygenator- with left port, 4-liter Reservoir, XC modified to Advance, Sterile Catalog Number: 3CX*FX25...
Respiratory Devices·5,079 affected·Nov 11, 2020
High RiskFDA
Westmed, Inc.
REF 0562, Adult Elongated O2/CO2 Mask, 10'X0.50 GSL w/ Swivel Elbow, 2" Pigtail w/Female Luer Connectors, 7' Oxygen Supply Tubing, Rx Onl...
Respiratory Devices·6,000 affected·Nov 11, 2020
High RiskFDA
Westmed, Inc.
REF 0562K (Adult Elongated O2/CO2 Mask - Product Usage: intended to connect with an oxygen source to deliver oxygen therapy to the patient.
Respiratory Devices·16,000 affected·Nov 11, 2020
High RiskFDA
Intersurgical Inc
Smoothbore breathing system with exhalation port 22 mm Device REF #: B0062001 Custom Anasthesia Breathing Systems; Multipac Anasthesia Br...
Medical Devices·200 affected·Nov 11, 2020
High RiskFDA
Canon Medical System, Usa, Inc.
Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A
Medical Devices·3 affected·Nov 11, 2020
High RiskFDA
Westmed, Inc.
REF 0930 Adult Elongated CO2/O2 Mask, 7' Tubing w/ Threaded Nut, Sivel GSE, 10' GSL X .038" ID X .107" OD, Reflective Luer Connectors, Rx...
Respiratory Devices·600 affected·Nov 11, 2020
High RiskFDA
Welch Allyn, Inc/mortara
ELI 380 Electrocardiograph - Product Usage: intended to be a high-performance, multichannel resting electrocardiograph. As a resting elec...
Medical Devices·1,009 affected·Nov 11, 2020
High RiskFDA
Eywa Pharma Inc
Levetiracetam Tablets, USP 500 mg, packaged in 120-count bottle, Rx only, Manufactured by: VKT Pharma Private Limited Srikakulam, India -...
Oral Drugs·5,451 affected·Nov 10, 2020
High RiskFDA
Merit Medical Systems, Inc.
Product Code: K05T-02533, Custom Inflation Kit, Custom K05 Sterile EO, Rx Only, (01)00884450255803 For Angiography/angioplasty. The...
Surgical Devices·90 affected·Nov 10, 2020
High RiskFDA
Merit Medical Systems, Inc.
Custom Procedure Kit, Cardiac Cath Pack, Product Code: K12T-10996 Rev. B, Sterile EO, Rx Only, (01)00884450515105 For Angiography/angi...
Cardiac Devices·80 affected·Nov 10, 2020
High RiskFDA
Merit Medical Systems, Inc.
Product Code: K12T-02871, Revision A, Custom Procedure Kit, Embolization Kit Sterile EO, Rx Only, (01)00884450339121 For Angiography/a...
Surgical Devices·42 affected·Nov 10, 2020
High RiskFDA
Tissuetech, Inc.
PROKERA Plus, non-sterile - Product Usage: Biologic corneal bandage.
Medical Devices·10 affected·Nov 10, 2020
High RiskFDA
Cryolife, Inc.
CryoValve SG Pulmonary Human Heart Valve. The valve is cryopreserved in a tissue culture medium containing cryoprotectants within the in...
Cardiac Devices·3 affected·Nov 10, 2020
High RiskFDA
Baxter Healthcare Corporation
MiniCap Extended Life PD Transfer Set
Medical Devices·72,771 affected·Nov 10, 2020
High RiskFDA
Tissuetech, Inc.
PROKERA, non-sterile - Product Usage: Biologic corneal bandage.
Medical Devices·63 affected·Nov 10, 2020
High RiskFDA
Tissuetech, Inc.
PROKERA Slim, non-sterile - Product Usage: Biologic corneal bandage.
Medical Devices·75 affected·Nov 10, 2020
High RiskFDA
Mayer Brothers Apple Products, Inc.
1. Giant brand " Premium Apple Cider*** 64 fl. oz. (Half Gal) 1.89L***Distributed by Foodhold USA LLC, Landover, MD 20785" 2. "Nature'...
Food·27,189 affected·Nov 9, 2020