29 results
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14ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
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Kit: Central Line Dres Change 20/Cs
FDA Recall
Terminated
·Medical Action Industries, Inc.·Product code PEZ·September 8, 2021
Kit: CentralLineDresChangeClrSeq MAI Kit Part Number: 79420
FDA Recall
Terminated
·Medical Action Industries, Inc.·Product code PEZ·April 9, 2021
Regard SRHS Central Line Kit, Sterile, 20/case - Product Usage: The Saline Flush Syringes are intended to be used only for the flushing of indwelling of vascular access devices.
FDA Recall
Terminated
·Resource Optimization & Innovation LLC·Product code PEZ·May 4, 2020
Kit: LVAD Dres Chg. MAI Kit Part Number: 79544B
FDA Recall
Terminated
·Medical Action Industries, Inc.·Product code PEZ·April 9, 2021
Hudson RCI Sheridan: 1) EZ-ENDO 6.0 mm, Product Code 5-22512 2) EZ-ENDO 6.5 mm, Product Code 5-22513 3) EZ-ENDO 7.0 mm, Product Code 5-22514 4) EZ-ENDO 7.5 mm, Product Code 5-22515 5) EZ-ENDO 8.0 mm, Product Code 5-22516 6) EZ-ENDO 8.5 mm, Product Code 5-22517 Product Usage: Tracheal tube/airway management
FDA Enforcement
Class I
·Terminated·Teleflex Medical·June 26, 2019
EZ adjust aluminum crutch under the following labels: 1) EZ adjust aluminum crutch, adult, 1 pair per case, 2) EZ adjust aluminum crutch, adult, 8 pairs per case, 3) EZ adjust aluminum crutch, youth, 1 pair per case, 4) EZ adjust aluminum crutch, youth, 8 pairs per case, 5) EZ adjust aluminum crutch, tall adult, 1 pair per case & 6) EZ adjust aluminum crutch, tall adult, 8 pairs per case
FDA Enforcement
Class II
·Terminated·Medical Depot Inc.·July 6, 2016
Hudson RCI Sheridan: 1) EZ-ENDO 6.0 mm, Product Code 5-22512 2) EZ-ENDO 6.5 mm, Product Code 5-22513 3) EZ-ENDO 7.0 mm, Product Code 5-22514 4) EZ-ENDO 7.5 mm, Product Code 5-22515 5) EZ-ENDO 8.0 mm, Product Code 5-22516 6) EZ-ENDO 8.5 mm, Product Code 5-22517 Product Usage: Tracheal tube/airway management
FDA Recall
Terminated
·Teleflex Medical·Product code BTR·May 24, 2019
EZ adjust aluminum crutch under the following labels: 1) EZ adjust aluminum crutch, adult, 1 pair per case, 2) EZ adjust aluminum crutch, adult, 8 pairs per case, 3) EZ adjust aluminum crutch, youth, 1 pair per case, 4) EZ adjust aluminum crutch, youth, 8 pairs per case, 5) EZ adjust aluminum crutch, tall adult, 1 pair per case & 6) EZ adjust aluminum crutch, tall adult, 8 pairs per case
FDA Recall
Terminated
·Medical Depot Inc.·Product code INP·February 17, 2016
AsthmaNefrin Starter Kit contains ten (10) AsthmaNefrin vials and one (1) EZ Breathe Atomizer. For the delivery of liquid medications for respiratory usage.
FDA Enforcement
Class I
·Terminated·Nephron Pharmaceuticals Corp.·June 5, 2013
AsthmaNefrin Starter Kit contains ten (10) AsthmaNefrin vials and one (1) EZ Breathe Atomizer. For the delivery of liquid medications for respiratory usage.
FDA Recall
Terminated
·Nephron Pharmaceuticals Corp.·Product code CCQ·April 30, 2013
Naviscan PET Systems, Inc ("Naviscan") PEM Flex Solo II PET Scanner. The PEM Flex Solo II images small body parts with optimized PET technology.
FDA Recall
Terminated
·Naviscan PET Systems·Product code KPS·June 19, 2008
PEMView Software used with Naviscan PEM Flex Solo I and PEM Flex Solo II PET Scanner, for nuclear medicine imaging.
FDA Recall
Terminated
·Naviscan PET Systems·Product code KPS·August 1, 2007
DermaPen Pro Model, Micro Needling System, a motorized AC powered surgical instrument for dermabrasive use. Each motorized handpiece is packaged within a small box. Each disposable needle cartridge is packaged individually and then placed into boxes of 30 quantities per box.
FDA Recall
Terminated
·Derma Pen, LLC·Product code PIU·February 5, 2015
DermaPen Pro Model, Micro Needling System, a motorized AC powered surgical instrument for dermabrasive use. Each motorized handpiece is packaged within a small box. Each disposable needle cartridge is packaged individually and then placed into boxes of 30 quantities per box.
FDA Enforcement
Class II
·Terminated·Derma Pen, LLC·September 16, 2015
Siemens Models: BIOGRAPH, BIOGRAPH LSO and CTI Models: REVEAL HD, REVEAL RT
FDA Recall
Terminated
·Cti Pet Systems Inc·Product code KPS·October 2, 2003
ECAT Software Versions V7.1.1b, V7.2, V7.2.1, and V7.2.2 used in the following PET (Positron Emission Tomography) systems: Siemens Models: ECAT EXACT, ECAT EXACT HR, ECAT EXACT HR+, ECAT ART, ECAT EMERGE and ECAT ACCEL CTI Models: ECAT EXACT, ECAT EXACT HR+, ECAT ART, ECAT EMERGE, ECAT ACCEL, REVEAL QS and REVEAL XL Marconi Models: Magellan Hitachi Models: Sceptre and Sceptre XL
FDA Recall
Terminated
·Cti Pet Systems Inc·Product code KPS·March 4, 2003
PET/CT Software Versions MSV 1.0 and 1.1 used in the following PET (Positron Emission Tomography) and X-Ray Computed Tomography (CT) systems: Siemens Models: Biograph PET/CT CTI Models: Reveal PET/CT
FDA Recall
Terminated
·CTI PET Systems Inc·Product code KPS·May 27, 2004
ECAT PET Scanners (mobile systems), distributed by Siemens Medical Solutions ECAT PET Scanners (mobile systems), and Reveal XL (mobile systems), distributed by CTI Molecular Imagining, Inc. Sceptre and Sceptre XL (mobile systems) distributed by Hitachi Medical Systems America
FDA Recall
Terminated
·CTI PET Systems Inc·Product code KPS·April 5, 2005
Pump Tube Set for MMS Libra and Solar Systems - Product Usage: Intended for use during water perfusion urodynamic procedures to study the function of the bladder and urethra during filling and voiding, by monitoring pressure and pressure changes.
FDA Recall
Terminated
·LABORIE MEDICAL TECHNOLOGIES, CANADA ULC·Product code FEZ·April 22, 2020
Siemens Prisma 2K Hearing Aid Product Usage: A behind the ear (BTE) hearing aid developed for pediatric patients.
FDA Recall
Terminated
·Siemens Hearing Instruments, Inc·Product code LEZ·July 1, 2005