Abbott Diabetes Care, Inc.
Alameda, CA
This page shows every FDA and USDA recall linked to Abbott Diabetes Care, Inc.. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
57
Total Recalls
2005
First Recall
2026
Most Recent
FreeStyle Libre 3 Plus Sensor REF 72080-01
UDI-DI code: 00357599819002
The FreeStyle Libre 3 Plus sensor is a...
Jan 14, 2026
· Device
Open, Classified
FreeStyle Libre 3 Sensor REF 72081-01
UDI-DI code: 00357599818005
The FreeStyle Libre 3 sensor is a component...
Jan 14, 2026
· Device
Open, Classified
FreeStyle Libre 3 Plus Sensor REF 78769-01
UDI-DI code: 00357599843014
The FreeStyle Libre 3 Plus sensor is a...
Jan 14, 2026
· Device
Open, Classified
FreeStyle Libre 3 Plus Sensor REF 78768-01
UDI-DI code: 00357599844011
The FreeStyle Libre 3 Plus sensor is a...
Jan 14, 2026
· Device
Open, Classified
FreeStyle Libre 3 Sensors, REF: 72081-01, component of the FreeStyle Libre 3 Continuous Glucose Monitoring Sys...
Aug 27, 2024
· Device
Open, Classified
FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Android 13 Operating Sys...
Jan 16, 2024
· Device
Completed
FreeStyle Libre 2 Readers, REF: 71951-01 and 71953-01, used with FreeStyle Libre 2 System
Aug 17, 2023
· Device
Open, Classified
FreeStyle Libre Reader, REF: 71525-01, 71701-01, 71739-01 a component of the FreeStyle Libre Flash Glucose Mon...
Apr 6, 2023
· Device
Open, Classified
FreeStyle Libre Reader, REF: 71936-01, 71937-01, 71938-01 a component of the FreeStyle Libre 14 Day Flash Gluc...
Apr 6, 2023
· Device
Open, Classified
FreeStyle Libre Reader, REF: 71951-01, 71952-01, 71953-01 a component of the FreeStyle Libre 2 Flash Glucose M...
Apr 6, 2023
· Device
Open, Classified
Precision Xtra Blood Glucose & Ketone Monitoring System, UDI: 00093815715023, 00093815988144
Feb 28, 2020
· Device
Terminated
FreeStyle Precision H Blood Glucose and Ketone Monitoring System, UDI: 00093815711810
Feb 28, 2020
· Device
Terminated
Optium EZ Blood Glucose Monitoring System, UDI: 00093815710653
Feb 28, 2020
· Device
Terminated
FreeStyle Blood Glucose Monitors System.
For in vitro diagnostic use only. Store at room
temperature below 86...
Mar 18, 2014
· Device
Terminated
FreeStyle Flash Blood Glucose Monitors System.
Meter made in China;
Distributed by TheraSense, Alameda, CA...
Mar 18, 2014
· Device
Terminated
FreeStyle Blood Glucose Test Strips;
For in vitro diagnostic testing.
50 count
UPC 6 99073 12050 2;
Freestyle...
Dec 17, 2013
· Device
Terminated
FreeStyle Lite Blood Glucose Test Strips;
For in vitro diagnostic testing.
50 count; 100 count Product of Ire...
Dec 17, 2013
· Device
Terminated
FreeStyle InsuLinx Blood Glucose Monitoring System:
For In Vitro Diagnostic Use only. Use only with FreeStyle...
May 9, 2013
· Device
Terminated
FreeStyle Blood Glucose Monitoring System Test Strips and Freestyle Lite Blood Glucose Monitoring System Test...
Feb 15, 2011
· Device
Terminated
Abbott Diabetes Care, MediSense Optium Blood Glucose Test Strips;
MediSense Optium Blood Glucose Electrodes;
Feb 9, 2011
· Device
Terminated
Abbott Diabetes Care, Precision Xtra Blood Glucose Test Strips;
Precision Xtra Blood Glucose & Ketone Monitori...
Feb 9, 2011
· Device
Terminated
Abbott Diabetes Care Optium EZ Blood Glucose Test Strips;
Feb 9, 2011
· Device
Terminated
Abbott Diabetes Care Precision Xceed Pro Blood Glucose Test Strips
Feb 9, 2011
· Device
Terminated
Abbott Diabetes Care, Optium Blood Glucose Test Strips;
Feb 9, 2011
· Device
Terminated
Abbott Diabetes Care, Precision Point of Care Blood Glucose Test Strips;
Feb 9, 2011
· Device
Terminated
Abbott Diabetes Care, ReliOn Ultima Blood Glucose Test ;
Feb 9, 2011
· Device
Terminated
Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, System Kit MMOL (EMEA) SV. Abbott I...
Apr 30, 2010
· Device
Terminated
Freestyle Navigator Continuous Glucose Monitor System, ABB NAV Dutch System Kit CE RE, AND ABB SYSTEM KIT, MMO...
Apr 30, 2010
· Device
Terminated
Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, Replacement Kit, Transmitter, Abbott I...
Apr 30, 2010
· Device
Terminated
Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, Reorder/Warranty Kit EMEA, Abbott Item...
Apr 30, 2010
· Device
Terminated
Freestyle Navigator Continuous Glucose Monitor System, Clinical System Kit, Packaging. Abbott Item Number:...
Apr 30, 2010
· Device
Terminated
Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, ABB SYSTEM KIT(ORANGE)PACK NAV, Abbott...
Apr 30, 2010
· Device
Terminated
Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, System, Business 1, MMOL. Abbott It...
Apr 30, 2010
· Device
Terminated
Freestyle Navigator Continuous Glucose Monitor System, Assy, Transmitter Poly Contac, Abbott Item Number: PRT...
Apr 30, 2010
· Device
Terminated
Freestyle Navigator Continuous Glucose Monitor System, Clinical Transmitter, Abbott Item Number: PRT 03831-09...
Apr 30, 2010
· Device
Terminated
Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, System, Business 1, MMOL (EMEA) UK....
Apr 30, 2010
· Device
Terminated
Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, ABB Warranty Kit Xmitter Nav, Abbott I...
Apr 30, 2010
· Device
Terminated
Freestyle Navigator Continuous Glucose Monitor System, System Kit, Business 1, (Orange). Abbott Item Number:...
Apr 30, 2010
· Device
Terminated
Freestyle Navigator Continuous Glucose Monitor System, ABB Transmitter Navigator. Abbott Item Number: PRT 03...
Apr 30, 2010
· Device
Terminated
Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, System Kit Business I, MG, and Syste...
Apr 30, 2010
· Device
Terminated
Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, System Kit MG EMEA and System Kit M...
Apr 30, 2010
· Device
Terminated
Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, System Kit MMOL EMEA. Abbott Item...
Apr 30, 2010
· Device
Terminated
Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, ABB System Kit MG, EMEA, DE. Abbott I...
Apr 30, 2010
· Device
Terminated
Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, SYSTEM KIT PACKAGING , Abbott Item Nu...
Apr 30, 2010
· Device
Terminated
Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, SYSTEM KIT PACKAGING ORANGE, Abbott I...
Apr 30, 2010
· Device
Terminated
Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, System Kit Business I, MG,(E). Abbot...
Apr 30, 2010
· Device
Terminated
FreeStyle Lite Blood Glucose Test Strips, CSP, 50's US, Checkpoint, FS Lite, for use with FreeStyle Lite Blood...
Sep 1, 2009
· Device
Terminated
Abbott brand FreeStyle Navigator, Receiver Warranty Kit, Blood Glucose Monitoring System, Part Number: 70789-0...
May 20, 2009
· Device
Terminated
Abbott FreeStyle Blood Glucose Monitoring System Test Strips for use with FreeStyle Blood Glucose Monitoring M...
Sep 11, 2008
· Device
Terminated
Blood glucose meter, marketed with multiple brand names including: Precision Xtra New and Improved meter, Prec...
Feb 14, 2008
· Device
Terminated