32 results
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11ms
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Sources: EU EUDAMED, US FDA
GE Healthcare LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, diagnostic ultrasound system
FDA Recall
Open, Classified
·GE Medical Systems China Co., Ltd. Dev. Zone National Hi-Tech; No.·Product code IYN·May 16, 2025
GE Healthcare Versana Ultrasound Systems, sold under the following names and Model/Catalog Numbers: 1) Versana Premier R3 VS, Model/Catalog Number 5938558; 2) Versana Premier R3 VA, Model/Catalog Number 5938559; 3) Versana Premier Lotus 4PP, Model/Catalog Number 5938560; 4) Versana Premier Lotus 5PP, Model/Catalog Number 5938561; 5) Versana Premier R3 VA Vet, Model/Catalog Number 5946387; 6) Versana Premier R3 VS Vet, Model/Catalog Number 5946481. 7) Versana Premier R3 Expert, Model/Catalog Number 5946950; 8) Versana Premier R3, Model/Catalog Number 5946951; 9) Versana Premier R3 Pro, Model/Catalog Number 5946952; 10) Versana Premier R3 Elite, Model/Catalog Number 5946953; 11) Versana Premier R3 Plus, Model/Catalog Number 5946954; 12) Versana Premier R3 Ultra, Model/Catalog Number 5946955; 13) Versana Premier R3 Max, Model/Catalog Number 5946956; 14) Versana Premier R3 Super, Model/Catalog Number 5946957; 15) Versana Premier R3 VS India, Model/Catalog Number 5948398; 16) Versana Premier R3 VA India, Model/Catalog Number 5948399; diagnostic ultrasound system
FDA Recall
Open, Classified
·GE Medical Systems China Co., Ltd. Dev. Zone National Hi-Tech; No.·Product code IYN·May 16, 2025
Titan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; inflatable penile Prosthesis
FDA Recall
Open, Classified
·Coloplast Manufacturing US, LLC·Product code FHW·March 1, 2023
Titan Touch NB Scrot Zero 18cm, Catalog Number EN29182400; inflatable penile Prosthesis
FDA Recall
Open, Classified
·Coloplast Manufacturing US, LLC·Product code FHW·March 1, 2023
Titan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; inflatable penile Prosthesis
FDA Recall
Open, Classified
·Coloplast Manufacturing US, LLC·Product code FHW·March 1, 2023
Titan Touch NB Infr Zero 16cm, Catalog Number EN28162400; inflatable penile Prosthesis
FDA Recall
Open, Classified
·Coloplast Manufacturing US, LLC·Product code FHW·March 1, 2023
Titan 0-Deg Scrotal 18 Cm, Catalog Number ES89182400; inflatable penile Prosthesis
FDA Recall
Open, Classified
·Coloplast Manufacturing US, LLC·Product code FHW·March 1, 2023
Titan NB Infra Zero Ang 16cm, Catalog Number EN88162400; inflatable penile Prosthesis
FDA Recall
Open, Classified
·Coloplast Manufacturing US, LLC·Product code FHW·March 1, 2023
Titan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis
FDA Recall
Open, Classified
·Coloplast Manufacturing US, LLC·Product code FHW·March 1, 2023
Titan Touch Infr Zero Ang 22cm, Catalog Number ES28222400; inflatable penile Prosthesis
FDA Recall
Open, Classified
·Coloplast Manufacturing US, LLC·Product code FHW·March 1, 2023
Titan Touch Infr Zero Ang 18cm, Catalog Number ES28182400; inflatable penile Prosthesis
FDA Recall
Open, Classified
·Coloplast Manufacturing US, LLC·Product code FHW·March 1, 2023
Titan Touch NB Infr Zero 18cm, Catalog Number EN28182400; inflatable penile Prosthesis
FDA Recall
Open, Classified
·Coloplast Manufacturing US, LLC·Product code FHW·March 1, 2023
Titan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile Prosthesis
FDA Recall
Open, Classified
·Coloplast Manufacturing US, LLC·Product code FHW·March 1, 2023
Toothbrushes, labeled as: ORAL B TOOTH BRUSH SHINY CLEAN SOFT 12CT; COLGATE TOOTH BRUSH MED. 12CT; ADULT TOOTHPASTE W BRUSH (WHITENING) 6.4oz/24ct; ADULT TOOTHPASTE W BRUSH (ANTICAV) 6.4oz/24ct.
FDA Recall
Open, Classified
·GOLD STAR DISTRIBUTION INC·Product code EFW·December 26, 2025
Titan Touch Scro Zero Ang 20cm, Catalog Number ES29202400; inflatable penile Prosthesis
FDA Recall
Open, Classified
·Coloplast Manufacturing US, LLC·Product code FHW·March 1, 2023
Titan Touch Scro Zero Ang 16cm, Catalog Number ES29162400; inflatable penile Prosthesis
FDA Recall
Open, Classified
·Coloplast Manufacturing US, LLC·Product code FHW·March 1, 2023
Titan Touch Pump, Catalog Numbers 5177502400; inflatable penile Prosthesis
FDA Recall
Open, Classified
·Coloplast Manufacturing US, LLC·Product code FHW·March 1, 2023
Titan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400; inflatable penile Prosthesis
FDA Recall
Open, Classified
·Coloplast Manufacturing US, LLC·Product code FHW·March 1, 2023
Titan Touch Scro Zero Ang 22cm, Catalog Number ES29222400; inflatable penile Prosthesis
FDA Recall
Open, Classified
·Coloplast Manufacturing US, LLC·Product code FHW·March 1, 2023
Titan 0-Deg Scrotal 22 Cm, Catalog Number ES89222400; inflatable penile Prosthesis
FDA Recall
Open, Classified
·Coloplast Manufacturing US, LLC·Product code FHW·March 1, 2023