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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 1527 of 1581

Evidence Product Join Root cause
device-recall:cfres:149668 Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 WMTS Smart-hopping (1.4GHz) Product Number: 865350 Exchange part: 453564262491 453564262511 453564615311 453564615331 453564262571 453564262591 USA only SW Revisions: B.05.28, B.05.29, and B.05.32 Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals Official recall number · Z-0291-2017 Software design
device-recall:cfres:149124 Sagittal Blade 18.0X0.97X90MM, Model Number: 6118-097-090 Product Usage: Heavy duty Sagittal Blades are used to cut bone and bone related tissue in a variety of orthopedic procedures. Typical procedures include, total-knee, uni-compartmental knee, hip, shoulder and ankle procedures. These blades can be used with the following handpieces; 4208-000-000 (SYSTEM 5 SAGITTAL SAW) 6208-000-000 (SYSTEM 6 SAG SAW) 6298-000-000 (ES6 SAGITTAL SAW) 7208-000-000 (SYSTEM 7 SAG SAW) Official recall number · Z-0112-2017 Packaging
device-recall:cfres:149815 Laparotomy Tray, Kit number PSS1538 convenience custom kits used for general surgery in hospital operating room Official recall number · Z-0223-2017 Unknown/Undetermined by firm
device-recall:cfres:149928 Upper Extremity Pack, Kit number AMS2536 and AMS2536(A convenience custom kits used for general surgery in hospital operating room Official recall number · Z-0280-2017 Unknown/Undetermined by firm
device-recall:cfres:147446 Calix T PEEK Lumbar System, TLIF Trial Official recall number · Z-0127-2017 Component design/selection
device-recall:cfres:147445 Calix T PEEK Lumbar System, TLIF Rasp Official recall number · Z-0126-2017 Component design/selection
device-recall:cfres:148414 CORE¿ Suction Irrigation Handpiece Y-Tubing set, with 5mm x 32cm Length Probe for Single Solution or Dual Bags, Catalog Number CD8200 The CORE Suction/Irrigation Y Tubing Set with Trumpet Valves (CD8200) is indicated for use in gynecological and abdominal surgery for Official recall number · Z-0131-2017 Under Investigation by firm
device-recall:cfres:149939 Virginia Custom Pack, Kit number RMS1744 convenience custom kits used for general surgery in hospital operating room Official recall number · Z-0284-2017 Unknown/Undetermined by firm
device-recall:cfres:150193 Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing. Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing Official recall number · Z-0117-2017 Device Design
device-recall:cfres:149656 Cardiac Cath Pack, kit number AMS2707 convenience custom kits used for general surgery in hospital operating room Official recall number · Z-0161-2017 Unknown/Undetermined by firm
device-recall:cfres:149658 Custom Arterial Pack, kit number RMS1712(F convenience custom kits used for general surgery in hospital operating room Official recall number · Z-0163-2017 Unknown/Undetermined by firm
device-recall:cfres:170586 Bentson PTFE Wire Guide, Guidewire, Global Product Number G14589, G14590 Official recall number · Z-0959-2020 Process control
device-recall:cfres:180044 TRUMATCH Orthognathic - Full Bimaxillary Surgical Kit, Catalog Number SD980.001 Official recall number · Z-1484-2020 Employee error
device-recall:cfres:180003 RayStation/RayPlan 9A, Build Number 9.0.0.113, stand-alone software treatment planning system Official recall number · Z-1467-2020 Under Investigation by firm
device-recall:cfres:179628 Econocare Plus Overlay Item: 1025EC. Intended to aid in the prevention and treatment of pressure injuries and general comfort - Product Usage: The EHOB WAFFLE Overlay intended use is as first line of defense for pressure injury prevention. The design provides the caregiver a point-of-care solution with the versatility of patient handling and transferring, which encourages ease of use and compliance. The design provides airflow to aid in patient comfort and pressure injury prevention. Official recall number · Z-1457-2020 Material/Component Contamination
device-recall:cfres:180001 RayStation/RayPlan 8B Service Pack 1, Build Number 8.1.1.8, stand-alone software treatment planning system Official recall number · Z-1465-2020 Under Investigation by firm
device-recall:cfres:180131 Encina HA Femoral Stem, Size 11 Coxa Vara Collared, REF 100-30-011, Ti6AI4V Allow with HA Coating, For use with Stinson Orthopedics Inc. Total Hip Replacement System Only, CEMENTLESS, UDI: (01) 00841176102934 Official recall number · Z-1568-2020 Labeling Change Control
device-recall:cfres:179843 1. X-Port isp M.R.I Implantable Port, with Pre-Attached 9.6 F Open-Ended Single-Lumen Venous Catheter, REF:0607550, UDI:(01)00801741026195 2. X-Port isp M.R.I. Implantable Port, with Attachable 9.6F Open-Ended Single-Lumen Venous Catheter, REF: 0657525, UDI:(01)00801741026379 Product Usage: Bard implantable ports are indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples. Official recall number · Z-1578-2020 Component change control
device-recall:cfres:179655 1.PowerPort Implantable Port With Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter REF: 1709600, Air Guard, With suture Plugs, (01)00801741026720; 2. PowerPort Implantable Port With Attachable 9.6 F Open-Ended Single- Lumen Venous Catheter, REF: 1709601, Air Guard, Without Suture Plugs, (01)00801741026737; 3. PowerPort Implantable Port with Pre-Attached 9.6F Open-Ended Single-Lumen Venous Catheter, REF: 1759600 Air Guard, With Suture Plugs, (01)00801741026850 Product Usage: Bard implantable ports are indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples. Official recall number · Z-1570-2020 Component change control
device-recall:cfres:180095 Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039 Official recall number · Z-1603-2020 Under Investigation by firm
device-recall:cfres:179341 CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 6MM(H) Reference Number: IEHA356 Official recall number · Z-1371-2020 Process control
device-recall:cfres:179609 Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-502 Product Usage: Used in facilities such as Central Sterile Supply Departments, next to the Operating Room, in dental clinics or hospital wards to clean, thermally or chemically disinfect and dry surgical goods. Official recall number · Z-1390-2020 Employee error
device-recall:cfres:179420 MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, HyperSoft 3D, Sterile, Rx, REF numbers 100102HS3D-V, 100103HS3D-V, 100152HS3D-V, 100153HS3D-V, 100154HS3D-V, 100202HS3D-V, 100203HS3D-V, 100204HS3D-V, 100206HS3D-V, 100208HS3D-V, 100254HS3D-V, 100256HS3D-V, 100304HS3D-V, 100306HS3D-V, 100310HS3D-V, 100355HS3D-V, 100358HS3D-V, 100406HS3D-V, 100408HS3D-V, 100412HS3D-V, 100415HS3D-V, 100510HS3D-V, 100515HS3D-V; MV-00102HTDA, MV-00103HTDA, MV-00204HTDA,MV-00304HTDA, MV-00306HTDA, MV-00406HTDA, MV-00408HTDA, MV-00510HTDA, MV-01502HTDA, MV-01503HTDA, MV-01504HTDA; MV-02504HTDA, MV-02506HTDA, MV-03505HTDA, and MV-03508HTDA. Product Usage: The MCS is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature. The firm name on the label is MicroVention, Inc., Tustin, CA. Official recall number · Z-1393-2020 Process design
device-recall:cfres:179481 MicroVention Terumo HydroSoft 10, HydroCoil Embolic System, Endovascular Embolization Coil, HydroSoft 3D, Sterile, Rx, REF numbers 100102HFRM-V, 100152HFRM-V, 100153HFRM-V, 100154HFRM-V, 100202HFRM-V, 100206HFRM-V, 100208HFRM-V, 100254HFRM-V, 100256HFRM-V, 100308HFRM-V, MV-00202HHTA, MV-00203HHTA, MV-00204HHTA, MV-00206HHTA, MV-00208HHTA, MV-00304HHTA, MV-00306HHTA, MV-00308HHTA, MV-00310HHTA, MV-00408HHTA, MV-00412HHTA, MV-00510HHTA, MV-00515HHTA, MV-00612HHTA, MV-00619HHTA, MV-00715HHTA, MV-00728HHTA, MV-00817HHTA, MV-00833HHTA, MV-01502HHTA, MV-01503HHTA, MV-01504HHTA, MV-02504HHTA, MV-02506HHTA, and MV-02508HHTA. Product Usage: The HES is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature. The firm name on the label is MicroVention, Inc., Tustin, CA. Official recall number · Z-1405-2020 Process design
device-recall:cfres:178615 Centurion- Uterine Sound 67465 STERILE SIMS UTERINE SOUND (83360) Y 2019032790 Official recall number · Z-1068-2020 Packaging process control

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