61 results
·
18ms
·
Sources: EU EUDAMED, US FDA
Filters
FDA Recall
×
PVA, PREVENT is an FDA-authorized emergency ventilator designed to treat patients suffering from COVID-19 respiratory failure. This motorized device automatically compresses a resuscitator bag to provide air to the lungs of a COVID-19 patient, eliminating the human error and fatigue that results from manual actuation. PREVENT is indicated for emergency resuscitation with appropriate patient monitoring on adult patients that require mechanical respiratory support.
FDA Recall
Open, Classified
·Precision Valve & Automation, Inc·Product code BTL·June 26, 2020
Cook Polyvinyl Alcohol Foam (PVA ) Embolization Particles, particle size 47-90 microns, 1 cc; order number PVA-50.
FDA Recall
Terminated
·Cook, Inc.·July 1, 2003
Cook Polyvinyl Alcohol Foam (PVA) Embolization Particles, particle size 180-300 microns, 1 cc; order number PVA-200.
FDA Recall
Terminated
·Cook, Inc.·July 1, 2003
Cook Polyvinyl Alcohol Foam (PVA) Embolization Particles, particle size 710-1000 microns, 1 cc; order number PVA-700.
FDA Recall
Terminated
·Cook, Inc.·July 1, 2003
Cook Polyvinyl Alcohol Foam (PVA) Embolization Particles, particle size 300-500 microns, 1 cc; order number PVA-300.
FDA Recall
Terminated
·Cook, Inc.·July 1, 2003
Cook Polyvinyl Alcohol Foam (PVA) Embolization Particles, particle size 500-710 microns, 1 cc; order number PVA-500.
FDA Recall
Terminated
·Cook, Inc.·July 1, 2003
Cook Polyvinyl Alcohol Foam (PVA) Embolization Particles, particle size 90-180 microns, 1 cc; order number PVA-100.
FDA Recall
Terminated
·Cook, Inc.·July 1, 2003
Synthes Zero-P VA Implant 7 MM Height Parallel Sterile The Synthes Zero-P VA Implant 7 MM Height Parallel Sterile is a stand alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1.
FDA Recall
Terminated
·Synthes USA HQ, Inc.·Product code OVE·September 30, 2013
Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, preservation, and examination of stool specimens for intestinal parasites Catalog Number: 301012
FDA Recall
Open, Classified
·Meridian Bioscience Inc·Product code IGG·October 19, 2023
PVA Foam Surgical Spears Catalog #: OASIS0525
FDA Recall
Terminated
·Ultracell Medical Technologies·Product code HOZ·January 8, 2003
Para-Pak Clean Vial-For the collection, transportation, preservation, and examination of stool specimens containing intestinal parasites Catalog Number: 900312
FDA Recall
Open, Classified
·Meridian Bioscience Inc·Product code FMH·October 19, 2023
Cardinal Health Clean Stool Transportation System-For the collection, transportation, preservation, and examination of stool specimens containing intestinal parasites Catalog Number: CHB900312
FDA Recall
Open, Classified
·Meridian Bioscience Inc·Product code FMH·October 19, 2023
Lasik Custom Pak containing 1 dual tip irrigator, 8 ports, 16 G, 2 packs spears, eye, ocucel, 5S, PVA, 1 cover, support, tray 2.2MIL 6FD, and 2 dressings, tegaderm, 2 3/8 x 2 3/4. All contents considered sterile unless package is opened or damaged.RX Only. Part number 10162-01. (The Vidaurri LASIK Flap Irrigators are included in the firm''s Alcon Custom Pak Part Number 10162-01 under the description of dual tip irrigator, 8 ports, 16G.)
FDA Recall
Terminated
·Alcon Research, Ltd·Product code LQJ·September 2, 2005
BARD Biopsy Systems (A Business Unit of Bard Peripheral Vascular, Inc.), UltraClip Dual Trigger Breast Tissue Marker 17g X 10cm needle, Ultrasound Enhanced Ribbon Marker 5 Pack, Sterile, Single Use, Non-pyrogenic, Rx only; Bard Peripheral Vascular, Inc., 1625 West 3rd Street, Tempe, AZ 85281 USA. PK4313800 Rev. 1 01/11 The UltraClip Dual Trigger breast tissue marker is a sterile, single use device comprised of a disposable introducer, and a metal implantable tissue marker with polyvinyl alcohol (PVA).
FDA Recall
Terminated
·Bard Peripheral Vascular Inc·Product code NEU·January 23, 2013
BARD Biopsy Systems (A Business Unit of Bard Peripheral Vascular, Inc.), UltraClip Dual Trigger Breast Tissue Marker 17g X 10cm needle, Ultrasound Enhanced Coil Marker 5 Pack; Sterilize, Non-pyrogenic, Rx only, Single Use; Bard Peripheral Vascular, Inc., 1625 West 3rd Street, Tempe, AZ 85281 USA. PK4320100 Rev. 0 03/10 The UltraClip Dual Trigger breast tissue marker is a sterile, single use device comprised of a disposable introducer, and a metal implantable tissue marker with polyvinyl alcohol (PVA).
FDA Recall
Terminated
·Bard Peripheral Vascular Inc·Product code NEU·January 23, 2013
MEDRAD Avanta Fluid Management Injection System, Catalog numbers: AVA 500 TABL, AVA 500 PEDL Product Usage: Administration of intravascular radio-opaque contrast media and common flushing solutions during angiographic procedures.
FDA Recall
Terminated
·Medrad Inc·Product code DXT·June 2, 2011
Avanta Multi-Patient Administration Tube Sets (AVA 500 MPAT (Part 2 of 2)) used with the Medrad Avanta Injection System; Catalog number: AVA 500 MPAT (Part 2 of 2); Affected material numbers: 87629007, 60729458, 86566648;
FDA Recall
Open, Classified
·Bayer Medical Care, Inc.·Product code DXT·April 24, 2026
GE Healthcare Advantage Workstations, Advantage Worksation version 4.2 and 4.3 with Volume Viewer 2 (version 6.4-6.8) provided with Advance Vessel Analysis (AVA) and Advantage Worksation 4.4 with Volume Viewer 2 (version 6.8 or before) or Volume Viewer 3 (version 7.2 -7.3) provided with Advanced Vessel Analysis (AVA), Model 2378698-2,GE Healthcare, Waukesha, WI. 53188
FDA Recall
Terminated
·GE Healthcare·Product code LLZ·September 10, 2007
Lotus TAVR 27mm, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System; Sterile Material number H749LTV270, Catalog Number LTV27; Product Usage: The Lotus Valve System is intended to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area [AVA] of <1.0 cm2 or AVA index of <0.6 em /m2) who are at extreme or high risk for standard surgical valve replacement.
FDA Recall
Terminated
·Boston Scientific Corporation·Product code NPT·November 19, 2014
Lotus TAVR 25mm, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System; Sterile Material number H749LTV250, Catalog Number LTV25; Product Usage: The Lotus Valve System is intended to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area [AVA] of <1.0 cm2 or AVA index of <0.6 em /m2) who are at extreme or high risk for standard surgical valve replacement.
FDA Recall
Terminated
·Boston Scientific Corporation·Product code NPT·November 19, 2014