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All Product Recalls

49,195 recalls from FDA (high severity)

Source:AllCPSCFDAUSDASeverity:AllCriticalHighMedium
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
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
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
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
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
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
High RiskFDA
Roi Cps Llc
Custom procedure packs, containing banded 4x4 Raytec 16ply gauze sponges. 1) Regard, PACEMAKER, Item 800221010, Lot # 82466. 2) Regar...
Cardiac Devices·17,700 affected·Nov 9, 2020
High RiskFDA
Exactech, Inc.
Equinoxe Humeral Stem, Primary, Press Fit, 11mm
Medical Devices·14 affected·Nov 9, 2020
High RiskFDA
Shimadzu Medical Systems
Shimadzu Mobile X-Ray System, MobileDaRt Evolution (MX8 Version), with adjustable handle option, Made in Japan - Product Usage: The devic...
Medical Devices·115 affected·Nov 9, 2020
High RiskFDA
Icu Medical, Inc.
icumedical Cogent" Hemodynamic Monitoring System - Product Usage: intended for patients for whom the monitoring of continuous cardiac out...
Cardiac Devices·220 affected·Nov 9, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
NaturaLyte Liquid Acid concentrate drums, Model Number 13-1251-1 - Product Usage: used in conjunction with Fresenius Renal Technologies S...
Medical Devices·51 affected·Nov 7, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-4231-0 - Product Usage: used in conjunction with Fresenius Renal Technologies...
Medical Devices·1,726 affected·Nov 7, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
NaturaLyte Liquid Acid concentrate drums, Model Number 13-2201-5 - Product Usage: used in conjunction with Fresenius Renal Technologies S...
Medical Devices·27 affected·Nov 7, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2201-5 - Product Usage: used in conjunction with Fresenius Renal Technologies...
Medical Devices·5,765 affected·Nov 7, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2351-8 - Product Usage: used in conjunction with Fresenius Renal Technologies...
Medical Devices·577 affected·Nov 7, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
NaturaLyte Liquid Acid concentrate drums, Model Number 13-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies S...
Medical Devices·592 affected·Nov 7, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-1301-4 - Product Usage: used in conjunction with Fresenius Renal Technologies...
Medical Devices·527 affected·Nov 7, 2020