142 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Open, Classified
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VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2
FDA Recall
Open, Classified
·Ortho-Clinical Diagnostics, Inc.·Product code CGN·July 3, 2024
BD FACSDuet Premium Sample Preparation System, REF: 666340, 666339; and BD FACSDuet Sample Preparation System (Base), REF: 663128, 662588, used with software V 1.4.1. Intended use: to prepare human specimens to be analyzed.
FDA Recall
Open, Classified
·Becton, Dickinson and Company, BD Bio Sciences·Product code PER·August 12, 2024
MEDLINE UNITE FOOT & ANKLE DRILL BIT, 1.3MM Solid Core, REF MPN10013
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code KRR·December 22, 2022
LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1 and v2.2
FDA Recall
Open, Classified
·ICU Medical, Inc.·Product code PHC·May 2, 2025
Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00 Product Usage: Shoulder surgery
FDA Recall
Open, Classified
·Exactech, Inc.·Product code KWT·August 21, 2018
1.5MM Drill Bit/QC/85MM Sterile-surgical, orthopedic, pneumatic powered & accessory/attachment Part Number: 310.15S
FDA Recall
Open, Classified
·Synthes (USA) Products LLC·Product code HSZ·January 24, 2024
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted routes of administration.
FDA Recall
Open, Classified
·Fresenius Kabi USA, LLC·Product code FRN·January 10, 2025
2.5MM DRILL BIT/QC/GOLD/110MM STERILE-surgical, orthopedic, pneumatic powered & accessory/attachment Product Code: 310.25S
FDA Recall
Open, Classified
·Synthes (USA) Products LLC·Product code HSZ·January 24, 2024
Integra Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure. Catalog Number: INS5HND
FDA Recall
Open, Classified
·Integra LifeSciences Corp.·Product code HBG·April 17, 2024
BD Phoenix PMIC/ID-107: The Phoenix PMIC/ID panel is used for the rapid identification and susceptibility of most aerobic and facultative anaerobic gram-positive bacteria of human origin with selected antimicrobial agents when used with the BD Phoenix Automated Microbiology System. Catalog (Ref) Number: 448607
FDA Recall
Open, Classified
·Becton Dickinson & Co.·Product code LON·October 13, 2022
SureStep Foley Tray System BARD Lubri-Sil Foley Catheter Tray, REF: A942216
FDA Recall
Open, Classified
·C.R. Bard Inc·Product code MJC·July 17, 2025
Ref No: INSHITHND / Integra Cranial access kit (without Prep solutions) Bit and Guard. For access to the subarachnoid space or the lateral ventricles of the brain.
FDA Recall
Open, Classified
·Integra LifeSciences Corp.·Product code HBG·January 19, 2024
Ref No: INS5HND / Integra Cranial access kit (without Prep solutions) Bit and Guard. For access to the subarachnoid space or the lateral ventricles of the brain.
FDA Recall
Open, Classified
·Integra LifeSciences Corp.·Product code HBG·January 19, 2024
Integra Cranial access kit (without Prep solutions) Bit and Guard-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS5HND
FDA Recall
Open, Classified
·Integra LifeSciences Corp.·Product code HBG·October 19, 2023
SureStep Foley Tray System Lubri-Sil I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303414A
FDA Recall
Open, Classified
·C.R. Bard Inc·Product code MJC·July 17, 2025
SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303316A
FDA Recall
Open, Classified
·C.R. Bard Inc·Product code MJC·July 17, 2025
KLS martin Group KLS E-COUPLING ADAPTER REF PDEC-1000-2 E-Coupling Adapter Assembly used to connect the KLS driver (e.g. drill) to a driver bit that fits into the adapter.
FDA Recall
Open, Classified
·Pro-Dex Inc·Product code GET·February 14, 2023
Citrasate Liquid Acid concentrate drums, Model Number 13-3251-CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
FDA Recall
Open, Classified
·Fresenius Medical Care Holdings, Inc.·Product code KPO·November 7, 2020
ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322B4
FDA Recall
Open, Classified
·Getinge Usa Sales Inc·Product code FQO·May 29, 2024
Citrasate Liquid Acid concentrate bottles, Model Number 08-3251-CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
FDA Recall
Open, Classified
·Fresenius Medical Care Holdings, Inc.·Product code KPO·November 7, 2020