21 results · 13ms · Sources: EU EUDAMED, US FDA

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MEDLINE Medical Procedure Kits labeled as: 1) CV DRAPING/BASIN, Medline Kit Number/SKU DYNJ908483A; 2) CV DRAPING/BASIN, Medline Kit Number/SKU DYNJ908483B; 3) CV DRAPING/BASIN, Medline Kit Number/SKU DYNJ908483C; 4) CV DRAPING/BASIN 2PART PACK, Medline Kit Number/SKU DYNJ89414; 5) CVG BASIN PACK SC, Medline Kit Number/SKU DYNJ38052G; 6) T/A BASIN SET, Medline Kit Number/SKU DYNJ47941F; 7) VALVE BASIN PACK SC, Medline Kit Number/SKU DYNJ38054G.

FDA Recall
Open, Classified ·Product code KDD·May 4, 2026

Medline procedure kits labeled as: 1) CV NEONATAL PACK, Pack Number DYNJ67356

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code PPB·February 11, 2025

MEDLINE convenience kits labeled as: 1) ANGIO PACK #2, REFDYNJ39185D; 2) CV MINOR CATH LAB PACK, REFDYNJ44997J; 3) PLASTIC PACK, REFDYNJ58409C; 4) GENDER AFFIRMING SURGERY, REFDYNJ66252A; 5) ST CHARLES PORT, REFDYNJ909591

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OES·October 9, 2024

MEDLINE Medical Procedure Kits labeled as: 1) BNT CV PACK, Medline Kit Number/SKU DYNJ912271; 2) CV PACK PART 1, Medline Kit Number/SKU DYNJ31204D; 3) KIT PERIPHERAL VASCULAR MMC, Medline Kit Number/SKU DYNJ905368D; 4) KIT PERIVASCULAR MMC, Medline Kit Number/SKU DYNJ905368B; 5) VP SHUNT PACK, Medline Kit Number/SKU DYNJ46530I.

FDA Recall
Open, Classified ·Product code OFF·May 4, 2026

BD Alaris Pump Infusion Sets REF: 10013186, BD Alaris Pump Infusion Set, Back Check Valve, 3 SmartSite Y-sites LVP 60D DEHP FREE 3SS CV; REF: 2452-0007, BD Alaris Pump Infusion Set, 2 Back Check Valves, 3 SmartSite Y-sitesAS LVP 10D 3SS 2CV; REF: 2204-0007, BD Alaris Pump Infusion SetAS LVP 20D; REF: 24001-0007, BD Alaris Pump Infusion Set, Back Check Valve, SmartSite Y-siteAS LVP 20D SS CV; REF: 10015012, BD Alaris Pump Infusion Burette Set, 0.2 Micron Filter, Smallbore Tubing, SmartSite Port (Burette), SmartSite Y-siteAS LVP BUR 20D PE-Lined SMBORE SS 0.2M; REF: 2432-0007, BD Alaris Pump Infusion Set, 0.2 Micron Filter, Back Check Valve, 3 SmartSite Y-sitesAS LVP 20D 3SS 0.2M CV; REF: 2434-0007, BD Alaris Pump Infusion Set, 0.2 Micron Filter, Back Check Valve, SmartSite Y-siteAS LVP 20D SS 0.2M CV; REF: 2202-0007, BD Alaris Pump Infusion Set, 1.2 Micron FilterAS LVP 20D 1.2M; REF: 11426965, BD Alaris Pump Infusion Set, Back Check Valve, 5 SmartSite Y-sitesAS LVP 20D CV; REF: 10561554, BD Alaris Pump Infusion Set, 15 Micron Filter, Back Check Valve, 3 SmartSite Y-sitesAS LVP 20D DEHP FREE 3SS 15M CV; REF: 10863358, BD Alaris Pump Infusion Set, 15 Micron FilterAS LVP 20D DEHP FREE 15M; REF: 11171447, BD Alaris Pump Infusion Set, 2 Back Check Valves, 3 SmartSite Y-sitesAS LVP 20D 3SS 2CV; REF: 11532269, BD Alaris Pump Infusion Set, 0.2 Micron Filter, Back Check Valve, PE Lined Tubing, 2 SmartSite Y-sitesAS LVP 20D PE-LINED 2SS 0.2M CV; REF: 10010454, BD Alaris Pump Infusion Set, 0.2 Micron Filter, PE Lined Tubing, SmartSite Y-siteAS LVP 20D PE-LINED TUBING SS 0.2M; REF: 2465-0007, BD Alaris Pump Infusion Set, SmartSite Bag Access Non-Vented, 0.2 Micron Filter, Low Sorbing Tubing (PE Lined), SmartSite Y-siteAS LVP SS BAG 20D PE-Lined SS 0.2M; REF: 10010453, ASBD Alaris Pump Infusion Set, 1.2 Micron Filter, PE Lined Tubing, SmartSite Y-site LVP 20D PE-LINED TUBING SS 1.2M REF: 11419365, BD Alaris" Pump Infusion Set, Back Check Valve, Manifold, 3-Way Stopcock, 5 SmartSite" Y-sites REF: 10813621, BD Alaris" Pump Infusion Set, Back Check Valve, 3 Ganged 4-Way Stopcocks, 4 SmartSite" Y-sites REF: 2423-0007, BD Alaris" Pump Infusion Set, Back Check Valve, 2 Ganged 4-Way Stopcocks, 4 SmartSite" Y-sites REF: 10015896, BD Alaris" Pump Infusion Set, Back Check Valve, 2 Ganged 4-Way Stopcocks, 3 SmartSite" Y-sites REF: 24010-0007T, BD Alaris" Pump Infusion Set, Bonded Texium", Closed Male Luer with Priming Cap, Back Check Valve, 3 SmartSite" Y-sites REF: 10010483, BD Alaris" Pump Infusion Set, Vented Syringe Adapter, Smallbore Tubing REF: 2403-0007, BD Alaris" Pump Infusion Set, Half Set, SmartSite" Y-site REF: 24301-0007T, BD Alaris" Pump Infusion Set, SmartSite" Bag Access Non-Vented, 0.2 Micron Filter, PE Lined Tubing, Bonded Texium" Closed Male Luer with Priming Cap, SmartSite" Y-site

FDA Recall
Open, Classified ·CareFusion 303, Inc.·Product code FRN·July 8, 2025

Verigene Enteric Pathogens Nucleic Acid Test (EP) Model Number: 20-006-023

FDA Recall
Open, Classified ·Luminex Corporation·Product code OCC·October 30, 2020

Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number: 435-000 Software Version: N/A Product Description: Respiratory virus panel nucleic acid assay system Component: No

FDA Recall
Open, Classified ·Abbott Diagnostics Scarborough, Inc.·Product code OCC·March 4, 2025

VERIGENE Processor SP Model No. 10-0000-07. An in vitro diagnostic device intended for processing and identifying nucleic acids

FDA Recall
Open, Classified ·Luminex Corporation·Product code OCC·December 10, 2018

Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number: 435-000 Software Version: N/A Product Description: Respiratory virus panel nucleic acid assay system Component: No

FDA Recall
Open, Classified ·Abbott Diagnostics Scarborough, Inc.·Product code OCC·March 4, 2025

Panther Fusion Extraction Reagent-S, Ref PRD-04331, IVD, CE, Rx Only consisting of FCR-S Fusion Capture Reagent - S, Nucleic Acid in a buffered solution and FER-S Fusion Enhancer Reagent-S (Lithium Hydroxide Solution), UDI: 15420045509214

FDA Recall
Open, Classified ·Hologic, Inc·Product code OCC·October 10, 2019

Verigene Gram Negative Blood Culture Nucleic Acid Test v2 (BC-GNv2) Model Number: 20-006-026

FDA Recall
Open, Classified ·Luminex Corporation·Product code OCC·October 30, 2020

Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN) Model Number: 20-006-021

FDA Recall
Open, Classified ·Luminex Corporation·Product code OCC·October 30, 2020

Verigene Clostridium difficile Nucleic Acid Test Kit (CDF) Model Number: 20-006-022

FDA Recall
Open, Classified ·Luminex Corporation·Product code OCC·October 30, 2020

Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) Model Number: 20-006-018

FDA Recall
Open, Classified ·Luminex Corporation·Product code OCC·October 30, 2020

Roadrunner PC Hydrophilic Wire Guide, Hydrophilic Guidewire Reference Part Number/GPN: RPC-035145-0-5 G34131 RPC-035145 G18154 RPC-035145-5 G34132 RPC-038145-0-5 G34129 RFSPC-038145-0 G17539 RFSPC-035145 G17540 RPC-038145-0 G18155 RPC-035145-0 G18153 RFSPC-035145-0 G17542

FDA Recall
Open, Classified ·Cook Incorporated·Product code OCY·August 16, 2022

FILMARRAY TORCH MODULE BOX, HTFA-ASY-0003, HTFA-ASY-0003-W, HTFA-ASY-0003U

FDA Recall
Open, Classified ·BioFire Diagnostics, LLC·Product code OCC·August 7, 2024

BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems

FDA Recall
Open, Classified ·BioFire Diagnostics, LLC·Product code OCC·April 30, 2025

NxTAG Respiratory Pathogen Panel, REF: I051C0447

FDA Recall
Open, Classified ·Luminex Molecular Diagnostics Inc·Product code OCC·September 5, 2024

xTAG Respiratory Viral Panel (RVP): Box Label: xTAG RVP (Respiratory Viral Panel). Catalogue Number:I019C0111 in vitro diagnostic test

FDA Recall
Open, Classified ·Luminex Molecular Diagnostics·Product code OCC·July 16, 2019

Simplexa Flu A/B & RSV Direct Gen II, REF: MOL2655; including Reaction Mix REF: MOL2656; with previous assay definition v5.

FDA Recall
Open, Classified ·DiaSorin Molecular LLC·Product code OCC·January 30, 2023