42 results
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16ms
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Sources: EU EUDAMED, US FDA
Filters
FDA Recall
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VITEK 2 Gram Fungal Susceptibility card (AST-YS05), REF 411945, 20 cards per carton.
FDA Recall
Terminated
·Biomerieux Inc·Product code NGZ·April 20, 2017
ETEST CLINICAL FLUCONAZOLE FL 256 US S30, CATALOG 412333
FDA Recall
Open, Classified
·Biomerieux Inc·Product code NGZ·November 9, 2022
VITEK 2 REAGENT AST-GP67 TEST KIT 20 CARDS, CATALOG 22226
FDA Recall
Open, Classified
·Biomerieux Inc·Product code NGZ·November 9, 2022
Yeastone Broth, 11ML, 10/BOX YY3462
FDA Recall
Open, Classified
·Remel, Inc·Product code NGZ·March 24, 2026
Amplilink Software versions 1.1, 1.3, 1.4, 2.41. COBAS Amplicor CTA & NGA Tests
FDA Recall
Terminated
·Roche Molecular Systems, Inc.·Product code JJF·May 21, 2007
Piccolo Xpress chemistry analyzer, Model No. 1100-1001, Software version 2.1.55 (NGA)/3.1.35(Jen II)
FDA Recall
Terminated
·Abaxis Inc·Product code JJG·December 11, 2019
ABL 80 CO-OX SYSTEM, software versions 1.30 and 1.31 Additional Product Codes: CEM, CGA, CGZ, GHS, GKR, GLY, JFP, JGS, JIX, JJY, JPI The ABL 80 CO-OX SYSTEM is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose and oximetry in whole blood. The ABL 80 CO-OX SYSTEM is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting.
FDA Recall
Terminated
·Sendx Medical Inc·Product code CHL·February 20, 2009
ARCHITECT c8000 Processing Module; List Number 01G06-01. Manufactured by Toshiba Corporation, Medical Systems Division, Japan. Distributed by Abbott Laboratories Diagnostic Division, Irving, Texas
FDA Recall
Terminated
·Abbott Laboratories, Inc·Product code CGZ·June 10, 2004
Extension Line Slide Clamps; Product codes: SA-09847
FDA Recall
Terminated
·Arrow International Inc·Product code KGZ·April 11, 2018
VITROS chemistry Products Cl- Slides, Catalog No. 8445207 (which does NOT support Urine CL-). MicroSlides which contain reagents in a dry, multi-layered form.
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code CGZ·September 10, 2019
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. PB1500 15 DROP IV SET W/2 STOPCOCKS; Catalog Number: 490025.
FDA Recall
Open, Classified
·B Braun Medical Inc·Product code KGZ·October 29, 2025
Arrow Percutaneous Sheath Introducers
FDA Recall
Terminated
·Arrow International Inc·Product code KGZ·February 11, 2009
Neff DAgostino Percutaneous Access Set Accessories, Catheter Intended for single-puncture percutaneous access to facilitate placement of an .038 inch (0.97 mm) diameter working wire guide for interventional radiology procedures
FDA Recall
Terminated
·Cook Inc.·Product code KGZ·April 15, 2016
Check-Flo Hemostasis Assembly, Individual product is packaged in a Tyvek-film sterilizable outer pouch.
FDA Recall
Terminated
·Cook Inc.·Product code KGZ·February 1, 2017
Centeze Centesis Catheter, Catalog #: a) DRC-006-05, b) DRC-006-15,
FDA Recall
Terminated
·Galt Medical Corporation·Product code KGZ·May 2, 2018
Neff Percutaneous Access Set, Catalog Number NPAS-100-RH-NT
FDA Recall
Terminated
·Cook Inc.·Product code KGZ·May 2, 2019
Aprima Access Nonvascular Introducer Set Accessories, Catheter Intended for single-puncture percutaneous access to facilitate placement of an .038 inch (0.97 mm) diameter working wire guide for interventional radiology procedures
FDA Recall
Terminated
·Cook Inc.·Product code KGZ·April 15, 2016
Abbott ARCHITECT cSystems ICT Module, REF 09D28-03. Product Usage: The ARCHITECT cSystems ICT (Integrated Chip Technology) is used for the quantitation of sodium, potassium, and chloride in human serum, plasma, or urine.
FDA Recall
Terminated
·Abbott Laboratories, Inc·Product code CGZ·August 28, 2018
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. NF1503 15 DR UNIV SPIKE, INJ SITE, BCV; Catalog Number: 490062.
FDA Recall
Open, Classified
·B Braun Medical Inc·Product code KGZ·October 29, 2025
VITROS chemistry Products Cl- Slides, Catalog No. 6844471 (which supports Urine CL-). MicroSlides which contain reagents in a dry, multi-layered form.
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code CGZ·September 10, 2019