Skip to content
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 71 of 1581

Evidence Product Join Root cause
device-recall:cfres:191975 HUNTLEIGH Disposable intraoperative Probe, 8Mhz (box), REF DIPP10, containing 10 individual Disposable Intraoperative Probes, REF DIOP8 Official recall number · Z-0960-2022 Under Investigation by firm
device-recall:cfres:192430 Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonary Valve (TPV) Replacement Implantation System. Official recall number · Z-0927-2022 Under Investigation by firm
device-recall:cfres:192703 Artis Q zeego, Model Number 10848283 Official recall number · Z-0977-2022 Device Design
device-recall:cfres:192130 Beckman Coulter IRISpec CA/CB/CC control, Catalog #800-7211, containing 3 x 100 mL bottles each of CA Control, CB Control, and CC Control. Official recall number · Z-0984-2022 Under Investigation by firm
device-recall:cfres:192460 4.0mm x 12mm Cannulated Screw, Short Thread; Part number 3005-40012 Official recall number · Z-0959-2022 Device Design
device-recall:cfres:192441 Regard IV Start Kit for preparing and/or dressing a peripheral vein intravenous access site Official recall number · Z-0950-2022 Process control
device-recall:cfres:192641 Gallant HF Implantable Cardioverter Defibrillator REF# CDHFA500Q Official recall number · Z-0990-2022 Component design/selection
device-recall:cfres:192699 Artis zeego, Model Number 10280959 Official recall number · Z-0973-2022 Device Design
device-recall:cfres:192648 ORAcollect Dx, Catalog Number/SKU: OCD-100, OCD-100A. Material numbers: OCD-100, OCD-100.008, OCD-100.012, OCD-100.014+ACP078, OCD-100.014+ACP078, OCD-100.032 and OCD-100A, OCD-100A.022, OCD-100A.023, OCD-100A.024, OCD-100A.025 Official recall number · Z-0981-2022 Nonconforming Material/Component
device-recall:cfres:192791 Inactivated macrolide-resistant Mycoplasma genitalium Official recall number · Z-0955-2022 Process control
device-recall:cfres:187818 A-Series BiPAP A 40, A-Series BiPAP A30 Continuous Ventilator, Non-life Supporting Official recall number · Z-1958-2021 Device Design
device-recall:cfres:187964 HeartWare, HVAD Pump Implant Kit, REF MCS1705PU - Product Usage: indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination Therapy (DT) in patients for whom subsequent transplantation is not planned. Official recall number · Z-2072-2021 Nonconforming Material/Component
device-recall:cfres:187798 Philips Respironics E30 with Humidifier, Continuous Ventilator, Minimum Ventilatory Support, Facility Use; Product Numbers DSX9999H11, INX9999H19, RINX9999H19 The Philips Respironics E30 ventilator is intended to provide invasive and non-invasive ventilatory support for individuals with Respiratory Insufficiency. It is specifically for the care of adult and pediatric patients >7 years of age and >18kgs. Official recall number · Z-1972-2021 Device Design
device-recall:cfres:187197 10G DIRECT DOUBLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures. Official recall number · Z-1742-2021 Vendor change control
device-recall:cfres:187138 ZVplasty Drill, 10 Gauge, REF VCF-1006. For use in Orthopedic / spinal procedures. Official recall number · Z-1702-2021 Vendor change control
device-recall:cfres:187307 ZVplasty System, 15mm, Part# VCF-1015-1. For use in Orthopedic / spinal procedures. Official recall number · Z-1759-2021 Vendor change control
device-recall:cfres:187309 ZVplasty 10G, 15mm, Additional Level Kit, REF VCF-1015-1A. For use in Orthopedic / spinal procedures. Official recall number · Z-1761-2021 Vendor change control
device-recall:cfres:187198 10G DIRECT SINGLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures. Official recall number · Z-1743-2021 Vendor change control
device-recall:cfres:187097 Tranberg MR Stylet, 1.8mm/15G, 230mm, REF: 4013-06, Rx Only, Sterile EO - Product Usage: used with the Tranberg¿ MR Introducer; a device used to aid the insertion of the Laser Applicator into the tissue. Official recall number · Z-1781-2021 Equipment maintenance
device-recall:cfres:187179 ZVplasty Direct Access Bevel Tip Trocar, 11 Gauge, REF VCF-1022-11. For use in Orthopedic / spinal procedures. Official recall number · Z-1724-2021 Vendor change control
device-recall:cfres:187367 Atec Insignia Anterior Cervical Plate System, REF 136-0119, Insignia, ACP, 1-Level, 19 mm, Rx Only, Non-Sterile, UDI: (01)00190376268453 Official recall number · Z-1802-2021 Under Investigation by firm
device-recall:cfres:187385 Atec Insignia Anterior Cervical Plate System, REF 136-0350 Insignia, ACP, 3-Level, 50 mm, Rx Only, Non-Sterile, UDI: (01)00190376268569 Official recall number · Z-1816-2021 Under Investigation by firm
device-recall:cfres:186752 COVID-19 Self-Test Kit *** INNOVA *** 7T Official recall number · Z-1537-2021 No Marketing Application
device-recall:cfres:187953 CoreValve Evolut PRO Delivery Catheter System, REF: ENVPRO-14; ENVPRO-16; Official recall number · Z-2042-2021 Device Design
device-recall:cfres:187397 v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris System, Model H700123. The WorkMate Claris" System is a computer-based electrocardiographic recording and monitoring system designed for efficient capture, display, and retrieval of surface and intracardiac signals during cardiac EP studies. Official recall number · Z-1853-2021 Software Manufacturing/Software Deployment

Field note

Send feedback

We'll only use this to respond to your feedback.