21 results
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11ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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Philips Patient Information Center (PIC) iX Uninterruptable Power Supply (UPS): 1. APC (Schneider Electric IT Corporation) 120V Uninterruptable Power Supply Model: SCL500RM1U 2. APC (Schneider Electric IT Corporation) 230V Uninterruptable Power Supply Model: SCL500RMI1U
FDA Recall
Open, Classified
·Philips North America Llc·Product code MHX·March 22, 2024
CD11b APC: ASR, REF: 340936, and CE, REF: 333143
FDA Recall
Open, Classified
·Becton, Dickinson and Company, BD Biosciences·Product code MVU·October 25, 2023
BD Anti-Kappa APC (Cat. No. 341098) is an analyte specific reagent for the Anti-Kappa antibody, which specifically recognizes the kappa light chains of human immunoglobulins. Anti-Kappa is used for in vitro identification of cells expressing the kappa light chains using flow cytometry.
FDA Recall
Open, Classified
·Becton, Dickinson and Company, BD Biosciences·Product code MVU·March 25, 2022
PDS Plus Antibacterial (polydioxanone) Suture - PDS PLUS CLR 27IN(70CM) USP3-0(M2) S/A PC-25 PRIME. Intended for use in general soft tissue approximation, including use in pediatric cardiovascular tissue. Product Code: PDP9625H
FDA Recall
Open, Classified
·Ethicon, Inc.·Product code NEW·March 31, 2023
with Notch 22M/15F sold as part of Breas Medical MPV circuit 2 pc Kits: 006093, 006653, an accessory to ventilator device, Vivo 45LS. intended for partial insertion into a patient's mouth (in between the lips) to facilitate access to the respiratory system.
FDA Recall
Open, Classified
·Breas Medical, Inc.·Product code NOU·October 13, 2023
HXBL/WETEX/Genesis Biomedical Viral Transport Container, Model No. HX-K59 Activated Type
FDA Recall
Open, Classified
·Haimen Shengbang Laboratory Equipment Co. Ltd.
D, Sanhe
No. 50 Xue Qian Road; Sanhezhen Haimen
Nantong China·Product code QMC·July 12, 2022
3M Prevena Plus 125 Therapy Unit and System Kits REF: PRE3021US Prevena Plus Duo Peel and Place 20cm System Kit, US PRE3201US Prevena Plus Peel and Place 35 cm system Kit, US PRE3201 Prevena Plus Peel and Place 35 cm system Kit PRE4000US Prevena Plus 125 Therapy Unit, US PRE4001AU PREVENA PLUS SYSTEM KIT, AU PRE4001CA PREVENA PLUS SYSTEM KIT, CA PRE4001UK PREVENA PLUS SYSTEM KIT, UK PRE4001US PREVENA PLUS SYSTEM KIT, US PRE4001 PREVENA PLUS SYSTEM KIT PRE4001ZA PREVENA PLUS SYSTEM KIT, ZA PRE4010 PREVENA PLUS STANDALONE EXTENDED LIFE SYSTEM KIT PRE5001 PREVENA RESTOR ARTHRO-FORM SYSTEM KIT 33X30 CM PRE5101 PREVENA RESTOR ARTHRO-FORM SYSTEM KIT 46X30 CM PRE5221 PREVENA RESTOR BELLA-FORM SYSTEM KIT 21X19 CM PRE5321 PREVENA RESTOR BELLA-FORM SYSTEM KIT 24X22 CM PRE5421 PREVENA RESTOR BELLA-FORM SYSTEM KIT 29X27 CM PRE5501 PREVENA RESTOR AXIO-FORM SYSTEM KIT 29X28 CM
FDA Recall
Open, Classified
·KCI USA, INC.·Product code QFC·January 17, 2025
Philips Laser System, REF: LAS-100. Used in minimally invasive interventional procedures within the cardiovascular system, and for the removal of problematic pacemaker and defibrillator cardiac leads.
FDA Recall
Open, Classified
·Spectranetics Corporation·Product code LPC·October 14, 2022
Philips Laser System, REF LAS-100, Intermittent Operation, Duty cycle dependent upon device in use 100 - 240 VAC, 50/60HZ, 16 AM
FDA Recall
Open, Classified
·Spectranetics Corporation·Product code LPC·June 1, 2022
HXBL/WETEX/Genesis Biomedical Viral Transport Container, Custom Made
FDA Recall
Open, Classified
·Haimen Shengbang Laboratory Equipment Co. Ltd.
D, Sanhe
No. 50 Xue Qian Road; Sanhezhen Haimen
Nantong China·Product code QMC·July 12, 2022
HXBL/WETEX/Genesis Biomedical Viral Transport Container, Model No. HX-K59-1
FDA Recall
Open, Classified
·Haimen Shengbang Laboratory Equipment Co. Ltd.
D, Sanhe
No. 50 Xue Qian Road; Sanhezhen Haimen
Nantong China·Product code QMC·July 12, 2022
Edge Biologicals STERILE WATER, 3ML, 100/PK CAT T-0780 Sterile Water, 3mL, 10/PK - Sterile water is used in making dilutions of samples/transport media in preparation for microbial testing of the sample. It is also used for diluting sterile reagents and microorganism preparations
FDA Recall
Open, Classified
·Edge Biologicals Inc·Product code QMC·October 2, 2023
GE Vscan Extend, being sold as "Vscan Extend Dual DICOM"
FDA Recall
Open, Classified
·GE Healthcare, LLC·Product code IYO·November 4, 2021
GE Vscan Extend, being sold as "Vscan Extend Dual Wi-Fi"
FDA Recall
Open, Classified
·GE Healthcare, LLC·Product code IYO·November 4, 2021
GE Vscan Extend, being sold as "Vscan Extend Sector DICOM"
FDA Recall
Open, Classified
·GE Healthcare, LLC·Product code IYO·November 4, 2021
GE Vscan Extend, being sold as "Vscan Extend Sector Wi-Fi"
FDA Recall
Open, Classified
·GE Healthcare, LLC·Product code IYO·November 4, 2021
GE Vscan Extend, being sold as "Vscan Extend Sector USB"
FDA Recall
Open, Classified
·GE Healthcare, LLC·Product code IYO·November 4, 2021
GE Vscan Extend, being sold as "Vscan Extend Console"
FDA Recall
Open, Classified
·GE Healthcare, LLC·Product code IYO·November 4, 2021
GE Vscan Extend, being sold as "Vscan Extend Dual USB"
FDA Recall
Open, Classified
·GE Healthcare, LLC·Product code IYO·November 4, 2021
BD Anti-Kappa PE (Cat. No. 346587) is an analyte specific reagent for the Anti-Kappa antibody, which specifically recognizes the kappa light chains of human immunoglobulins. Anti-Kappa is used for in vitro identification of cells expressing the kappa light chains using flow cytometry.
FDA Recall
Open, Classified
·Becton, Dickinson and Company, BD Biosciences·Product code MVU·March 25, 2022