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Sources: EU EUDAMED, US FDA
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Bard CritiCore Monitor, Software Version 2.1, Catalog number 000002N, C.R. Bard, Inc., Covington, GA 30014. Intended for multiple uses as it is an electronic battery-operated monitor used in conjunction with a single-use disposable urine collection container and/or a temperature sensing Foley catheter
FDA Recall
Terminated
·C.R. Bard, Inc., Urological Division·Product code EXS·November 17, 2010
ENFIT G-TUBE CONNECTOR, MEDLINE Item No. ENFIT1010GC
FDA Recall
Open, Classified
·Product code PIO·February 13, 2026
Medline Kits containing ENFIT G-TUBE CONNECTOR 1. SKU DYKM2720 G/J TUBE CARE KIT 2. SKU ENFITDISCKIT ENFIT DISCHARGE KIT
FDA Recall
Open, Classified
·Product code PIO·February 13, 2026
AMT Male ENFit-to-Stepped Male (Christmas Tree) Adapter, Model Number ETRN102. Box PN TRN102, Box UDI (01)00842071109066(17)230901(10)200918-103, Pouch PN ETRN102, Pouch UDI (01)00842071108007(17)230901(10)200902-075
FDA Recall
Terminated
·Applied Medical Technology Inc·Product code PIO·November 10, 2020
C9-3io Transducer Probe
FDA Recall
Open, Classified
·Philips Ultrasound, Inc·Product code IYN·July 3, 2025
L15-7io Transducer Probe
FDA Recall
Open, Classified
·Philips Ultrasound, Inc·Product code IYN·July 3, 2025
L15-7IO TRANSDUCER Transducer Probe
FDA Recall
Open, Classified
·Philips Ultrasound, Inc·Product code IYN·July 3, 2025
The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field, to magnify the visual field using the magnifying feature of the iPhone, while simultaneously selecting a single number on the keyboard.
FDA Recall
Open, Classified
·Product code QRX·September 11, 2025
Omnipod 5 Automated Insulin Delivery System, iOS Application. Model Number: PT-000664/M009-S-AP. Software Version: all Product Description: The Omnipod 5 iOS App software is available to download through the Apple app store. The Omnipod 5 App is the user interface that controls the Omnipod 5 Automated Insulin Delivery System. It is used to activate/deactivate Pods, display alerts/alarms, and send insulin delivery commands for execution to the Pod. Only available in the US.
FDA Recall
Open, Classified
·Product code QRX·May 23, 2025
Bio-Rad brand ''TOX/See Drug Screen Test''; Catalog numbers: 1945182EX, 1945216, 194-5223
FDA Recall
Terminated
·Bio-Rad Laboratories Inc·Product code DIO·June 4, 2004
Capillary (end) caps, accessory for use with blood gas analyzers included in Radiometer''s CLINITUBES kits. The end caps are packaged in bags. These bags are placed in the capillary tube kit which also contains: capillary tubes, end caps, mixing wires, and a magnet. Each kit may contain 1 or 5 bags depending on the kit model. Each bag contains: 110 Green caps per bag and 160 Red caps per bag.
FDA Recall
Terminated
·Radiometer America Inc·Product code GIO·March 22, 2006
Separation Technology ClearCRIT Capillary Tubes 75mm/0.5mm ID. Catalog number 270-107. Separation Technology Inc, 1096 Rainer Drive, Altamonte Springs, FL 32714. Heparin-treated capillary tube used for spun hematocrit packed cell volume (PCV) determination.
FDA Recall
Terminated
·Drummond Scientific Co·Product code GIO·August 1, 2008
QuickTox Drug Screen DipCard(AMT Item/ AMT Description): QT70/ "QuickTox Drug Screen Dipcard 11 Drug Detection: COC300+OPI300+MET500+THC50+AMP1000+PCP25+BZO300+BAR300+MTD300+OXY100+MDMA500", QT88/ "QuickTox Drug Screen Dipcard 12 Drug Detection: COC300+OPI300+MET500+THC50+AMP1000+PCP25+BZO300+BAR300+MTD300+OXY100+ MDMA500+BUP10", QT11 / "QuickTox Drug Screen Dipcard 5 Drug Detection: COC300+OPI2000+THC50+AMP1000+PCP25", QT52/ "QuickTox Drug Screen Dipcard 9 Drug Detection: COC300+OPI300+MET500+THC50+AMP1000+BZO300+BAR300+MTD300+OXY100", QT44/ "QuickTox Drug Screen Dipcard 8 Drug Detection: COC300+OPI300+MET500+THC50+AMP1000+BZO300+BAR300+OXY100", QT23/ "QuickTox Drug Screen Dipcard 6 Drug Detection: COC300+OPI2000+MET500+THC50+AMP1000+PCP25", QT80F/ "QuickTox Drug Screen Dipcard 12 Drug Detection: COC300+OPI300+MET500+THC50+AMP1000+PCP25+BZO300+BAR300+MTD300+TCA1000+OXY100+MDMA500 with Positive Control Line", QT52A/ "QuickTox Drug Screen Dipcard 9 Drug Detection: COC300+OPI300+MET500+THC50+AMP1000+BZO300+BAR300+MTD300+OXY100 4 Adulteration Test: Cr, Ni, pH, Ox ", QT20/ "QuickTox" Drug Screen Dipcard 5 Drug Detection: COC300+OPI2000+MET500+THC50+AMP1000"
FDA Recall
Terminated
·Ameditech Inc·Product code DIO·August 18, 2020
Iris Sample Processing SafeCrit 40mm Tubes. Catalog number 59-000869-002 H. Iris Sample Processing, 60 Glacier Drive, Westwood, MA 02090. Heparin-treated capillary tube used for spun hematocrit packed cell volume (PCV) determination.
FDA Recall
Terminated
·Drummond Scientific Co·Product code GIO·August 1, 2008
Iris Sample Processing SafeCrit 75mm Tubes. Iris Sample Processing, 60 Glacier Drive, Westwood, MA 02090. Heparin-treated capillary tube used for spun hematocrit packed cell volume (PCV) determination.
FDA Recall
Terminated
·Drummond Scientific Co·Product code GIO·August 1, 2008
Capillary (end) caps, accessory for use with blood gas analyzers included in Radiometer''s CLINITUBES kits. The end caps are packaged in bags. These bags are placed in the capillary tube kit which also contains: capillary tubes, end caps, mixing wires, and a magnet. Each kit may contain 1 or 5 bags depending on the kit model. Each bag contains: 110
FDA Recall
Terminated
·Radiometer America Inc·Product code GIO·March 22, 2006
SARKEN STAT! 1- Panel Test Kit-COC Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing).
FDA Recall
Terminated
·Sarken, Inc.·Product code DIO·July 29, 2013
Alere iCup Drug Detection (AMT Item Number/ AMT Description): I-DXA-10/ "Alere" iCup Dx 10 Drug Detection + Adulteration AMP/BAR/BZO/COC/MET/MDMA/MTD/MOP/OXY/THC Bl, Cr, Ni, pH, SG", I-DXA-13B/"Alere" iCup DX Drug Screen Cup 13 Drug Detection + Adulteration AMP/BAR/BZO/BUPG/COC/MET/MDMA/MTD/MOP/OXY/PCP/THC/TCA Bl, Cr, Ni, pH, SG", I-DXA-1127-023-N "Alere" iCup Dx Drugs of Abuse Test (COC/THC)+(MET1000/OPI2000)+(MTD/TCA)+ (OXY/MDMA)+(PCP/AMP)+BAR+BZO With Cr, Ni, pH, Bl, S.G."
FDA Recall
Terminated
·Ameditech Inc·Product code DIO·August 18, 2020
SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 115 L; Prepared with Sodium Heparin Model/Catalog Number: 06 0005 Product Description: A clear, plastic capillary blood collection tube
FDA Recall
Open, Classified
·ASP Global, LLC. dba Anatomy Supply Partners, LLC.·Product code GIO·September 26, 2025
SAFE-T-FILL Micro Collection Tube Extender, Model 09 1004
FDA Recall
Open, Classified
·ASP Global, LLC. dba Anatomy Supply Partners, LLC.·Product code GIO·September 26, 2025