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

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Medline Convenience kits containing recalled Swan-Ganz Catheters OPEN HEART DYNJ909090B OPEN HEART CDS QVH CDS982523M

FDA Recall
Open, Classified ·Product code LRO·May 28, 2026

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ANGIO KIT PACK DYNJ50783B ANGIO PHC DYNJ37485C C.I.C.N. ANGIO PACK DYNJ53064B FHT P NEURO PACK DYNJ39931D NEURO ARTERIOGRAM PACK-LF DYNJ0948060F NEURO KIT NAM0003 NEURO PACK DYNJ61542D NEURO RADIOLOGY PACK DYNJ59903B NEURO TRAY DYNJ84872A PK, CATH LAB-ANGIO DYNJ44027F QVH IR NEURO PACK DYNJ62176

FDA Recall
Open, Classified ·Product code OJG·February 27, 2026

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIO PACK DYNJ30565C DYNJ32555B ANGIO PACK-LF DYNJ0774765U ANGIO TRAY DYNJ46153A ANGIOGRAM TRAY DYNJ33638K ANGIOGRAPHY DRAPE PK QVH-LF DYNJ35110D ANGIOGRAPHY PACK DYNJ44293D ANGIOGRAPHY PACK-LF DYNJ0854485T DYNJ35916J GENERAL ANGIO PACK DYNJ57760B GENERAL ENDO PACK-LF DYNJ0842873J JUDKINS PACK DYNJ51126A RADIOLOGY ANGIO MAJOR PACK DYNJ62858B TAVR JUDKINS PACK DYNJ51127B

FDA Recall
Open, Classified ·Product code OEQ·February 27, 2026

Medline Convenience kits containing recalled Swan-Ganz Catheters CABG A CDS CDS982269K CDS982269L CDS982269M CDS982269N CARDIAC MAJOR DYNJ901328D DYNJ901328F HEART A DYNJ903465F DYNJ903465G HEART TRAY-VASCULAR DYNJ907857 DYNJ907857A DYNJ907857B KIT UNIVERSITY CABG PK DYNJ905857A OPEN HEART CDS981161AA CDS981161AB DYNJ905437A DYNJ909090 DYNJ909090C DYNJ9855016R DYNJ9855016S OPEN HEART ACCESSORY CDS CDS984289J OPEN HEART ANESTHESIA PACK CDS983849D CDS983849F CDS983849G OPEN HEART B CDS DYNJ900377P OPEN HEART BASIC B DYNJ904311C OPEN HEART CDS CDS983513F OPEN HEART CDS QVH CDS982523K CDS982523L CDS982523N OPEN HEART LINE SET UP DYNJ908179 DYNJ908179A OPEN HEART SUPPLEMENT DYNJ909116 DYNJ909116A DYNJ909116C DYNJ909116D SILVER CROSS OPEN HEART DYNJ906102J DYNJ906102K DYNJ906102L SM OPEN HEART PACK A&B DYNJ904749G DYNJ904749J VPH OPEN HEART DYNJ902664J DYNJ902664K DYNJ902664L

FDA Recall
Open, Classified ·Product code OEZ·May 28, 2026

DEXCOM G6 SENSOR 3 PACK Item Number: 5447552

FDA Recall
Open, Classified ·Cardinal Health Inc.·Product code QBJ·March 16, 2021

Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dexcom G6 and G6 Pro Android US CGM App Model/Catalog Number: SW11678 Software Version: version 1.15.0 Product Description: Dexcom G6 and G6 Pro Android US CGM App SW11678 version 1.15.0 Component: Dexcom G6 Continuous Glucose Monitoring System

FDA Recall
Open, Classified ·Dexcom, Inc.·Product code QBJ·August 28, 2025

Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM iOS App Model/Catalog Number: SW12300 Software Version: Versions 2.9.0 through 2.11.2 Product Description: Dexcom G7 CGM iOS App Component: Dexcom G7 Continuous Glucose Monitoring System, Dexcom G7 15 Day Continuous Glucose Monitoring System

FDA Recall
Open, Classified ·Dexcom, Inc.·Product code QBJ·April 14, 2026

Continuous Glucose Monitor (CGM)

FDA Recall
Open, Classified ·GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden·Product code QBJ·November 3, 2025

Dexcom G6, Continuous Glucose Monitoring System, REF: STK-OR-001

FDA Recall
Open, Classified ·Dexcom, Inc.·Product code QBJ·January 27, 2025

Dexcom G6, Continuous Glucose Monitoring System, REFs: STK-OM-001, STR-OM-001, STR-OR-001

FDA Recall
Open, Classified ·Dexcom, Inc.·Product code QBJ·January 27, 2025

Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ iOS CGM App Model/Catalog Number: SW14244 Software Version: versions 1.4.0 and earlier Product Description: Dexcom ONE+ iOS CGM App Component: Dexcom ONE+ Continuous Glucose Monitoring System

FDA Recall
Open, Classified ·Dexcom, Inc.·Product code QBJ·July 24, 2025

Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM watchOS App Model/Catalog Number: SW13355 Software Version: versions 2.8.0 and earlier Product Description: Dexcom G7 CGM watchOS App - The watchOS app is installed along with the iOS phone app and the versions used of each are the same for each user. The watchOS app cannot be installed independently from the iOS phone app Component: Dexcom G7 CGM iOS App

FDA Recall
Open, Classified ·Dexcom, Inc.·Product code QBJ·July 24, 2025

Dexcom G7 iOS Application, Ref: SW12300 used in conjunction with the Dexcom G7 Continuous Glucose Monitoring (CGM) system

FDA Recall
Open, Classified ·Dexcom, Inc.·Product code QBJ·May 5, 2025

Dexcom One Continuous Glucose Monitoring System, SKUs(Part Number): STK-DO-006 (MT27409-1), STK-DO-013 (MT27409-1), STK-DO-103 (MT27409-2), STK-DO-109 (MT27409-2)

FDA Recall
Open, Classified ·Dexcom, Inc.·Product code QBJ·May 12, 2025

Dexcom One+ Continuous Glucose Monitoring System, SKU(Part Number): STK-D7-013 (MT28285-1), STK-D7-014 (MT28285-1), STK-D7-103 (MT28285-2)

FDA Recall
Open, Classified ·Dexcom, Inc.·Product code QBJ·May 12, 2025

Early Bird Bleed Monitoring System Introducer Sheath Set, REF: FG001-01 (6F), FG001-02 (8F)

FDA Recall
Open, Classified ·Saranas, Inc.·Product code QFJ·August 10, 2022

Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM watchOS App Model/Catalog Number: SW13355 Software Version: Versions 2.9.0 through 2.11.2 Product Description: Dexcom G7 CGM watchOS App - The watchOS app is installed along with the iOS phone app and the versions used are the same for each user. The watchOS app cannot be installed independently from the iOS phone app. Component: Dexcom G7 Continuous Glucose Monitoring System, Dexcom G7 15 Day Continuous Glucose Monitoring System

FDA Recall
Open, Classified ·Dexcom, Inc.·Product code QBJ·April 14, 2026

Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ iOS CGM App Model/Catalog Number: SW14244 Software Version: versions 1.5.0 and 1.6.0 Product Description: Dexcom ONE+ iOS CGM App Component: Dexcom ONE+ Continuous Glucose Monitoring System

FDA Recall
Open, Classified ·Dexcom, Inc.·Product code QBJ·April 14, 2026

Dexcom G6 Glucose Receiver, SKUs (Part Number): STK-FM-001 (MT27408-1) & STK-FR-001 (MT27408-1)

FDA Recall
Open, Classified ·Dexcom, Inc.·Product code QBJ·May 12, 2025

Dexcom G6, Continuous Glucose Monitoring System, REF: STK-OE-001

FDA Recall
Open, Classified ·Dexcom, Inc.·Product code QBJ·January 27, 2025