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Recall Observatory FDA recall evidence

Core noun

Device recall evidence

Joined enrichment rows that support device recall linkage and root-cause wording.

Indexed record set

39,516 evidence rows

Page 1528 of 1581

Evidence Product Join Root cause
device-recall:cfres:178610 Centurion-LVAD Kits DM1005 DAILY LVAD MAINTENANCE KIT DM280A LVAD MANAGEMENT SYSTEM 2-7 DM320 PERCUTANEOUS LEAD MANAGEMENT KIT DM380 DAILY LVAD KIT MORRISTOWN MEDICAL DM405A ADVOCATE CHRIST DAILY WET KIT DM405A ADVOCATE CHRIST DAILY WET KIT DM525 LVAD SENSITIVE KIT DM545 U OF U LVAD SENSITIVE SKIN DRESSING SYST DM550 VAD DRIVELINE MANAGEMENT TRAY DM555 LVAD MULTI-DAY DRIVELINE MGMT SIZE M/L DM565 LVAD DRESSING SYSTEM DM575 LVAD MULTI-DAY DRIVELINE MGMT SIZE S DM610 DRIVELINE MANAGEMENT SYSTEM-DAILY DM610 DRIVELINE MANAGEMENT SYSTEM-DAILY DM610 DRIVELINE MANAGEMENT SYSTEM-DAILY DM690 VAD DRIVELINE MANAGEMENT BUNDLE DM710 VAD DAILY DRESSING CHANGE KIT DM720 DAILY LVAD MAINTENANCE KIT DM765 DAILY DRIVELINE MANAGEMENT SYSTEM DM770 WEEKLY DRIVELINE MANAGEMENT SYSTEM DM775 EXTENDED WEAR DRIVELINE MANAGEMENT KIT DM775 EXTENDED WEAR DRIVELINE MANAGEMENT KIT DM805 DAILY LVAD DRIVELINE MANAGEMENT SYSTEM DM870 DAILY MAINTENANCE SYSTEM LVAD DM920 GAUZE DRIVELINE MANAGEMENT KIT DM925 SORBAVIEW DRIVELINE MANAGEMENT KIT DM935 DAILY DRIVELINE MANAGEMENT SYSTEM DM950 HIGH DRAINAGE LVAD TRAY Official recall number · Z-1063-2020 Packaging process control
device-recall:cfres:179084 Terumo Advanced Perfusion Assembly Pump Guts, 4 Inch, Catalog Number 801805 - Product Usage: is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical proffessional who is experienced in the operation of this or similar equipment. The roller pump is used to move fluids through the cardiopulmonary bypass circuit and can be used for a number of applicatinos including arterial blood pumping, cardioplegia delivery, suction, and venting. Official recall number · Z-1111-2020 Nonconforming Material/Component
device-recall:cfres:178609 Centurion-BIOPSY TRAY BT205A MINOR SET UP BIOPSY TRAY BT345A HH PACK BIOPSY Official recall number · Z-1062-2020 Packaging process control
device-recall:cfres:170630 Urethral Dilation Balloon Catheter with Open Tip , Global Product No. G17844 Official recall number · Z-0970-2020 Process control
device-recall:cfres:170627 Percutaneous Malecot Nephrostomy Set, Global Product No. G16714 G19107 G19108 Official recall number · Z-0968-2020 Process control
device-recall:cfres:178974 Terumo Advanced Perfusion System 1 Roller Pump, 4 Inch, Catalog Number 816570 - Product Usage: is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical proffessional who is experienced in the operation of this or similar equipment. The roller pump is used to move fluids through the cardiopulmonary bypass circuit and can be used for a number of applicatinos including arterial blood pumping, cardioplegia delivery, suction, and venting. Official recall number · Z-1108-2020 Nonconforming Material/Component
device-recall:cfres:178758 Medonic M-Series Hematology Analyzer M16S BD ABR US Product code: 1400075; OUS Product code 1400011 Official recall number · Z-1001-2020 Software design
device-recall:cfres:178930 HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04. Cochlear Implant. Official recall number · Z-1259-2020 Other
device-recall:cfres:179123 i-STAT CG4+ cartridge (blue), List No. 03P85-50. UDI (01) 00054749002269 - Product Usage: The i-STAT CG4+ cartridge is intended for the quantitative measurement of lactate, pH, pCO2, and pO2 in venous, arterial or capillary whole blood. Official recall number · Z-1263-2020 No Marketing Application
device-recall:cfres:179536 Philips HeartStart FRx AED, Model 861304, FRx codeRev: E.02.017 Official recall number · Z-1271-2020 Process control
device-recall:cfres:179743 DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Kwik Kit 89-6389.06 Official recall number · Z-1418-2020 Environmental control
device-recall:cfres:179201 Pentax Video Colonoscope Model: EC34-i10L Official recall number · Z-1267-2020 Mixed-up of materials/components
device-recall:cfres:179460 Ysio Max, model no. 10762470 - Product Usage: The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures f the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critical ill) applications. Exposures may be taken with the patient sitting, standing, or in the prone position. The Ysio max system is not meant for mammography. Official recall number · Z-1339-2020 Software design
device-recall:cfres:178501 Drill Tapered WP 5x11.5 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to implant placement. Official recall number · Z-1312-2020 Packaging process control
device-recall:cfres:179616 FilmArray NGDS Warrior Panel, Ref: NGDS-ASY-0007, UDI: (01)00851458005136, IVD, Rx Only Official recall number · Z-1448-2020 Labeling Change Control
device-recall:cfres:178675 Terumo AZUR Peripheral Coil System, Detachable 35, Helical HydroCoil Embolization System, REF numbers 45-451015, 45-451020, 45-451215, 45-451220, 45-451230, 45-451520, 45-451530, 45-452020, 45-452030, 45-450410, 45-450415, 45-450405, 45-450610, 45-450615, 45-450620, 45-450815, 45-450820, and MV-AZ52030HD, Sterile, Rx. The firm name on the label is MicroVention, Inc., Tustin, CA; Distributed By: Terumo Medical Corporation, Somerset, NJ; Made in Costa Rica. Official recall number · Z-1223-2020 Other
device-recall:cfres:179502 NC TRAVELER Coronary Dilatation Catheter, REF 1013157-15, Rx Only,NC Traveler RX 4.0 X 15MM The NC Traveler RX Coronary Dilatation Catheter is not cleared for commercial distribution in the United States. Official recall number · Z-1142-2020 Process change control
device-recall:cfres:179499 NC TREK Coronary Dilatation Catheter, REF 1012455-120 Rx Only,NC TREK RX 5.00 X 20MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion b) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction c) balloon dilatation of a stent after implantation (balloon models 2.00 mm 5.00 mm only) Official recall number · Z-1139-2020 Process change control
device-recall:cfres:176765 Toco MP Transducer (M2734B), that may have been serviced with the following: Pacific Medical Philips M2734B Avalon Smart TOCO Bottom Case, NFPHA9315-B Official recall number · Z-1168-2020 Device Design
device-recall:cfres:178882 ROSA One 3.1 Brain Application Official recall number · Z-1151-2020 Software design
device-recall:cfres:179085 SwishPlus Implant 5.7mmD x 8mmL, SBM 6.5mmD Platform, Part Number 925708 Official recall number · Z-1126-2020 Process control
device-recall:cfres:179331 Medicrea TLIF-B Holder, short intended for Intervertebral body fusion device Catalog: Number A24200010 Official recall number · Z-1156-2020 Process control
device-recall:cfres:178314 Trilogy EVO Ventilator, 02 - International - Model Number: IN2100X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate accessories. Official recall number · Z-0950-2020 Software design
device-recall:cfres:179532 TLC-2000 Therapeutic Medical Laser System Official recall number · Z-1266-2020 Process control
device-recall:cfres:178789 Y-Type Blood Set, Catalog Number 490530 Official recall number · Z-0939-2020 Nonconforming Material/Component

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