323 results
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19ms
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Sources: EU EUDAMED, US FDA
Medline Convenience kits labeled as: HSG TRAY, Pack Number DYNDH1453
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code HGD·April 8, 2024
Medline medical procedure kits labeled as follows: a) AAA CDS, REF CDS984011C; b) CAN KIT, REF DYKM1184; c) DENTAL CDS, REF CDS984010B; d) EGD KIT, REF DYK1253578F; e) EGD REG KIT, REF DYKE1830; f) ENDO KIT, REF DYKE1516A; g) ERCP REG KIT, REF DYKM2127; h) GI PACK, REF DYKE1898; i) KIT, PEG, REG, REF DYKM2128; j) KIT,1500CC, 50CS, REF DYKM2126; k) LITHOTOMY, REF DYNJ909937; l) MAJOR BASIC, REF DYNJ909703; m) MINOR GENERAL SURGERY, REF DYNJ909940; n) SUCTION SET UP KIT, REF DYKM1187A; o) TURNOVER KIT, REF DYKC1274A; p) TURNOVER KIT MKT STRAPS, REF DYKC1309A; q) U BAR, REF DYNJ902374K
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code LRO·March 22, 2024
Cepheid Xpert SA Nasal Complete Control Panel (Catalog #8196) UDI: 70845357041233 Product Usage: On April 9, 2019, Microbiologics sent ACTION REQUIRED: MEDICAL DEVICE CORRECTION emails to their direct US consignees requesting them to complete a MEDICAL DEVICE CORRECTION FORM indicating how much product they had on hand.
FDA Recall
Open, Classified
·Microbiologics Inc·Product code PMN·April 9, 2019
Cepheid Xpert MRSA/MRSA NxG Control Panel (Catalog #8195) UDI: 70845357041226 Product Usage: On April 9, 2019, Microbiologics sent ACTION REQUIRED: MEDICAL DEVICE CORRECTION emails to their direct US consignees requesting them to complete a MEDICAL DEVICE CORRECTION FORM indicating how much product they had on hand.
FDA Recall
Open, Classified
·Microbiologics Inc·Product code PMN·April 9, 2019
AVE 2 Birthing Bed - Product Usage: is designated to be used by mothers ready for spontaneous vaginal delivery and also as aid to search for individual positions providing relief in all delivery stages including postpartum period. Birthing bed is not intended for use as a general hospital bed.
FDA Recall
Open, Classified
·Linet Americas·Product code HDD·March 6, 2020
Philips Respironics V60 Ventilator Part Number DU1053617 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories. Philips Respironics V60 Ventilator Part Number U1053617 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories. Note: U1053617 added 1/29/2021 after noticing it had been inadvertently left off
FDA Recall
Open, Classified
·Respironics California, LLC·Product code MNT·November 2, 2020
UA WIN 10 Kit, Catalog Number C52900, in-vitro diagnostic device, urine analysis
FDA Recall
Open, Classified
·Beckman Coulter, Inc.·Product code KQO·April 5, 2023
DxU 840m Iris Urine Microscopy Analyzer, Catalog Number C76947, in-vitro diagnostic device, urine analysis
FDA Recall
Open, Classified
·Beckman Coulter, Inc.·Product code KQO·April 5, 2023
DxU 850m Iris Urine Microscopy Analyzer Catalog Number C49513, in-vitro diagnostic device, urine analysis
FDA Recall
Open, Classified
·Beckman Coulter, Inc.·Product code KQO·April 5, 2023
iQ200 Series Urine Microscopy Analyzer: a) iQ 200 Select, Part Numbers C10684 and 700-3345; b) iQ 200 Elite, Part Numbers C10683 and 700-3375; in-vitro diagnostic device, urine analysis, c) iQ200 Select 1500, Part Number 700-3347, d) iQ200 Sprint, Part Number 700-3325
FDA Recall
Open, Classified
·Beckman Coulter, Inc.·Product code KQO·April 5, 2023
VADER pedicle system, torque wrench, Catalog Number 42-703
FDA Recall
Open, Classified
·Icotec Ag Industriestrasse 12 Altstatten Sg Switzerland·Product code PML·November 28, 2023
VADER pedicle system, torque wrench, Catalog Number 42-702
FDA Recall
Open, Classified
·Icotec Ag Industriestrasse 12 Altstatten Sg Switzerland·Product code PML·November 28, 2023
Cook Medical Biodesign Dural Graft, REF C-DUR-7X10, REF G31091, Sterile
FDA Recall
Open, Classified
·Cook Biotech, Inc.·Product code GXQ·November 22, 2024
Cook Medical Biodesign Hiatal Hernia Graft, REF C-PHR-7X10-U, REF G31455, Sterile; and
FDA Recall
Open, Classified
·Cook Biotech, Inc.·Product code OWV·November 22, 2024
Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile.
FDA Recall
Open, Classified
·Cook Biotech, Inc.·Product code KHJ·November 22, 2024
Phothera 200, Phototherapy Devices indicated for use to treat diagnosed skin disorders such as, but not limited to, Psoriasis, Vitiligo, and Atopic Dermatitis (Eczema) under the direction of a physician, Model Numbers 210NDT4 and 210NCL4
FDA Recall
Open, Classified
·Daavlin Distributing Company·Product code FTC·December 10, 2025
GEM DR Model 7271 Implantable Cardioverter-Defibrillator (ICD)
FDA Recall
Open, Classified
·November 14, 2002
HeartWare HVAD Pump Implant Kit, REF 1104
FDA Recall
Open, Classified
·Heartware, Inc.·Product code DSQ·June 3, 2021
HeartWare HVAD Implant Kit, REF MCS1705PU
FDA Recall
Open, Classified
·Heartware, Inc.·Product code DSQ·June 3, 2021
HeartWare HVAD Pump Accessories, REF MCS1753AK
FDA Recall
Open, Classified
·Heartware, Inc.·Product code DSQ·June 3, 2021