758 results
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Sources: EU EUDAMED, US FDA
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EPIONE Model 30-0001 UDI-DI code: 03760305400031 The EPIONE device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one or more instruments, as well as in verification of instrument position during Computed Tomography (CT) guided percutaneous ablation procedures in the abdomen, performed by physicians trained for CT procedures and performed under general anaesthesia with rigid straight instruments such as needles and probes of diameters ranging from 11G to 19G.
FDA Recall
Open, Classified
·Product code JAK·May 23, 2025
VITROS Chemistry Products HbA1c Reagent Kit- IVD for the quantitative determination of percent glycated hemoglobin A1c (DCCT/NGSP) and mmol/mol hemoglobin A1c (IFCC) in human whole blood. Product Code: 6842905
FDA Recall
Open, Classified
·Ortho-Clinical Diagnostics, Inc.·Product code PDJ·April 17, 2023
Beckman Coulter DxU 850m/840m Microscopy Analyzers, Part Numbers: C49513, C76947
FDA Recall
Open, Classified
·Beckman Coulter, Inc.·Product code LKM·December 19, 2023
iQ Waste Well Adapter, Part Number: 700-3393
FDA Recall
Open, Classified
·Beckman Coulter, Inc.·Product code LKM·December 19, 2023
REV 2 Flowcell Capsule Spare, Part Number: C04154
FDA Recall
Open, Classified
·Beckman Coulter, Inc.·Product code LKM·December 19, 2023
iQ200 Series Urine Microscopy Analyzers, Part Numbers: a) 700-3320, b) 700-3370, c) 700-3345, d) 700-3347, e) C10683, f) 700-3375, g) 700-3325, h) C10684
FDA Recall
Open, Classified
·Beckman Coulter, Inc.·Product code LKM·December 19, 2023
Brand Name: STA Liatest Free Protein S Product Name: STA Liatest Free Protein S Model/Catalog Number (REF): 00516 Product Description: The STA - Liatest Free Protein S kits are intended for use on STA-R and STA Compact for the quantitative antigenic assay of free protein S in human citrated plasma by the immuno-turbidimetric method. Component: Not Applicable
FDA Recall
Open, Classified
·Diagnostica Stago, Inc.·Product code GGP·February 4, 2026
ADVIA Centaur Folate 100 test kit-For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10310308
FDA Recall
Open, Classified
·Siemens Healthcare Diagnostics, Inc.·Product code JJX·January 9, 2023
ADVIA Centaur Folate 500 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10325366
FDA Recall
Open, Classified
·Siemens Healthcare Diagnostics, Inc.·Product code JJX·January 9, 2023
Atellica IM Folate 700 test kit (REF)-For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 11206252
FDA Recall
Open, Classified
·Siemens Healthcare Diagnostics, Inc.·Product code CGN·January 9, 2023
Atellica IM Folate 140 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10995572
FDA Recall
Open, Classified
·Siemens Healthcare Diagnostics, Inc.·Product code CGN·January 9, 2023
Atellica IM Folate 700 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10995573
FDA Recall
Open, Classified
·Siemens Healthcare Diagnostics, Inc.·Product code CGN·January 9, 2023
ADVIA Centaur Folate 500 test kit (REF)-For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10331250 Siemens Material Number (SMN): 10325366
FDA Recall
Open, Classified
·Siemens Healthcare Diagnostics, Inc.·Product code JJX·January 9, 2023
Brand Name: Broselow Product Name: BROSELOW" FILLED BROSELOW ORGANIZER Model/Catalog Number: 7730IALS Software Version: Not Applicable Product Description: The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care. Component: no
FDA Recall
Open, Classified
·SunMed Holdings, LLC·Product code OKI·December 15, 2025
Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700REA Software Version: Not Applicable Product Description: The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care. Component: No
FDA Recall
Open, Classified
·SunMed Holdings, LLC·Product code OKI·December 15, 2025
Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700RE Software Version: Not Applicable Product Description: The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care. Component: No
FDA Recall
Open, Classified
·SunMed Holdings, LLC·Product code OKI·December 15, 2025
Brand Name: Broselow Product Name: Broselow Domestic Complete ALS Organizer Model/Catalog Number: 7730ALS Software Version: Not Applicable Product Description: The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care. Component: No
FDA Recall
Open, Classified
·SunMed Holdings, LLC·Product code OKI·December 15, 2025
Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175, for use in a pharmaceutical compounding device
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code LHI·August 20, 2024
Baxter EXACTAMIX Inlet, Vented, High Volume Inlet, REF H938174, for use in a pharmaceutical compounding device
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code LHI·August 20, 2024
Baxter EXACTAMIX Inlet, Non-Vented, High Volume Inlet, REF H938173, for use in a pharmaceutical compounding device
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code LHI·August 20, 2024