Abbott Diabetes Care, Inc.
FDA Regulatory Profile
Abbott Diabetes Care, Inc. appears in FDA public data with 18 recalls — including 13 Class I (most serious) —, 39 510(k) clearances, 14 FDA inspections, and 2 compliance actions on record. Its most recent recall (Z-1022-2026, Class I) was initiated on November 24, 2025. Its most recent 510(k) clearance was granted on June 7, 2024.
Summary
- Total Recalls
- 18 (13 Class I)
- 510(k) Clearances
- 39
- Inspections
- 14
- Compliance Actions
- 2
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1022-2026 | Class I | FreeStyle Libre 3 Plus Sensor REF 78769-01 UDI-DI code: 00357599843014 The FreeStyle Libre 3 Plus s | November 24, 2025 |
| Z-1020-2026 | Class I | FreeStyle Libre 3 Sensor REF 72081-01 UDI-DI code: 00357599818005 The FreeStyle Libre 3 sensor is a | November 24, 2025 |
| Z-1021-2026 | Class I | FreeStyle Libre 3 Plus Sensor REF 78768-01 UDI-DI code: 00357599844011 The FreeStyle Libre 3 Plus s | November 24, 2025 |
| Z-1023-2026 | Class I | FreeStyle Libre 3 Plus Sensor REF 72080-01 UDI-DI code: 00357599819002 The FreeStyle Libre 3 Plus s | November 24, 2025 |
| Z-2692-2024 | Class I | FreeStyle Libre 3 Sensors, REF: 72081-01, component of the FreeStyle Libre 3 Continuous Glucose Moni | July 24, 2024 |
| Z-2414-2023 | Class II | FreeStyle Libre 2 Readers, REF: 71951-01 and 71953-01, used with FreeStyle Libre 2 System | July 12, 2023 |
| Z-1273-2023 | Class I | FreeStyle Libre Reader, REF: 71525-01, 71701-01, 71739-01 a component of the FreeStyle Libre Flash G | February 13, 2023 |
| Z-1274-2023 | Class I | FreeStyle Libre Reader, REF: 71936-01, 71937-01, 71938-01 a component of the FreeStyle Libre 14 Day | February 13, 2023 |
| Z-1275-2023 | Class I | FreeStyle Libre Reader, REF: 71951-01, 71952-01, 71953-01 a component of the FreeStyle Libre 2 Flash | February 13, 2023 |
| Z-0734-2024 | Class II | FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Android 13 Ope | February 9, 2023 |
| Z-1558-2020 | Class II | FreeStyle Precision H Blood Glucose and Ketone Monitoring System, UDI: 00093815711810 | November 14, 2019 |
| Z-1556-2020 | Class II | Precision Xtra Blood Glucose & Ketone Monitoring System, UDI: 00093815715023, 00093815988144 | November 14, 2019 |
| Z-1557-2020 | Class II | Optium EZ Blood Glucose Monitoring System, UDI: 00093815710653 | November 14, 2019 |
| Z-1212-2014 | Class I | FreeStyle Flash Blood Glucose Monitors System. Meter made in China; Distributed by TheraSense, | February 19, 2014 |
| Z-1211-2014 | Class I | FreeStyle Blood Glucose Monitors System. For in vitro diagnostic use only. Store at room temperatu | February 19, 2014 |
| Z-0486-2014 | Class I | FreeStyle Lite Blood Glucose Test Strips; For in vitro diagnostic testing. 50 count; 100 count Pro | November 18, 2013 |
| Z-0485-2014 | Class I | FreeStyle Blood Glucose Test Strips; For in vitro diagnostic testing. 50 count UPC 6 99073 12050 | November 18, 2013 |
| Z-1245-2013 | Class I | FreeStyle InsuLinx Blood Glucose Monitoring System: For In Vitro Diagnostic Use only. Use only with | April 15, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K233861 | Libre Rio Continuous Glucose Monitoring System | June 7, 2024 |
| K233537 | FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring S | April 23, 2024 |
| K223435 | FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring S | April 13, 2023 |
| K222447 | FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose Monitoring S | March 3, 2023 |
| K223537 | FreeStyle Libre 2 System, FreeStyle Libre 3 System | February 21, 2023 |
| K213996 | FreeStyle Libre 3 Continuous Glucose Monitoring System | May 26, 2022 |
| K212132 | FreeStyle Libre 3 Continuous Glucose Monitoring System | May 26, 2022 |
| K210943 | FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) | November 22, 2021 |
| K211102 | FreeStyle Libre 2 Flash Glucose Monitoring System | August 11, 2021 |
| K201761 | FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) | July 30, 2021 |
| K193371 | FreeStyle Libre 2 Flash Glucose Monitoring System | June 12, 2020 |
| K171941 | FreeStyle Precision Neo Blood Glucose Test Strips | September 27, 2017 |
| K153330 | FreeStyle Precision Neo H Blood Glucose Monitoring System | February 19, 2016 |
| K142928 | FreeStyle Precision Neo Blood Glucose Monitoring System | September 30, 2015 |
| K140371 | FREESTYLE PRECISION NEO BLOOD GLUCOSE: MONITORING SYSTEM, TEST STRIPS (50CT), TEST STRIPS (100CT) | September 30, 2014 |
| K132511 | FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM | December 24, 2013 |
| K130094 | FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM | June 27, 2013 |
| K120568 | FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEM | March 29, 2012 |
| K092638 | FREESTYLE BLOOD GLUCOSE TEST STRIPS, MODELS 100-COUNT: 12401-01, 12101-21, 12101-22, 12101-23 | June 15, 2010 |
| K092602 | FREESTYLE Lite Blood Glucose Monitoring System and Freestyle Freedom Lite Blood Glucose Monitoring S | May 14, 2010 |