Abbott Diabetes Care recalls
Abbott Diabetes Care appears in 18 official U.S. recall notices indexed by RecallRadar, most recently on 2026-01-21.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 18 |
|---|---|
| Published | 2013-05-15 to 2026-01-21 |
| By agency | FDA Device (18) |
| By classification | Class I (13), Class II (5) |
| By status | ongoing (9), terminated (8), completed (1) |
| Distribution named in notices | AK, AL, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, PA, SC, SD, TN, TX, US, UT, VA, VT, WA, WI, WV, WY |
Recalls
- FreeStyle Libre 3 Plus Sensor REF 78768-01 UDI-DI code: 00357599844011 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Li…
FDA Device · Class I · 2026-01-21 · Abbott Diabetes Care
Reason: Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results - FreeStyle Libre 3 Sensor REF 72081-01 UDI-DI code: 00357599818005 The FreeStyle Libre 3 sensor is a component of the FreeStyle Libre 3 Cont…
FDA Device · Class I · 2026-01-21 · Abbott Diabetes Care
Reason: Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results - FreeStyle Libre 3 Plus Sensor REF 72080-01 UDI-DI code: 00357599819002 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Li…
FDA Device · Class I · 2026-01-21 · Abbott Diabetes Care
Reason: Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results - FreeStyle Libre 3 Plus Sensor REF 78769-01 UDI-DI code: 00357599843014 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Li…
FDA Device · Class I · 2026-01-21 · Abbott Diabetes Care
Reason: Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results - FreeStyle Libre 3 Sensors, REF: 72081-01, component of the FreeStyle Libre 3 Continuous Glucose Monitoring System
FDA Device · Class I · 2024-09-04 · Abbott Diabetes Care
Reason: Users of the FreeStyle Libre 3 sensors reported situations where they were receiving erroneously high glucose results. The inaccurate higher glucose values may lead to users calculating higher insulin bolus correctional… - FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Android 13 Operating System
FDA Device · Class II · 2024-01-24 · Abbott Diabetes Care
Reason: If using affected glucose monitoring app on Android 13 Operating System, extended periods of signal loss may be experienced, due to app not connected, which could impact ability to receive glucose reading/alarms, which… - FreeStyle Libre 2 Readers, REF: 71951-01 and 71953-01, used with FreeStyle Libre 2 System
FDA Device · Class II · 2023-08-23 · Abbott Diabetes Care
Reason: If blood glucose monitoring system users attempt to start a new sensor, when the old sensor wasn't used for the full 14-day wear time, then the reader may display "Incompatible Sensor" message. If users don't have the p… - FreeStyle Libre Reader, REF: 71936-01, 71937-01, 71938-01 a component of the FreeStyle Libre 14 Day Flash Glucose Monitoring System
FDA Device · Class I · 2023-04-12 · Abbott Diabetes Care
Reason: Lithium-ion batteries in glucose monitoring system readers may swell, overheat, or pose fire hazard. Only use the charging cable/power adapter included with readers. Do not use reader if it is damaged, cracked, swelling… - FreeStyle Libre Reader, REF: 71951-01, 71952-01, 71953-01 a component of the FreeStyle Libre 2 Flash Glucose Monitoring System
FDA Device · Class I · 2023-04-12 · Abbott Diabetes Care
Reason: Lithium-ion batteries in glucose monitoring system readers may swell, overheat, or pose fire hazard. Only use the charging cable/power adapter included with readers. Do not use reader if it is damaged, cracked, swelling… - FreeStyle Libre Reader, REF: 71525-01, 71701-01, 71739-01 a component of the FreeStyle Libre Flash Glucose Monitoring System
FDA Device · Class I · 2023-04-12 · Abbott Diabetes Care
Reason: Lithium-ion batteries in glucose monitoring system readers may swell, overheat, or pose fire hazard. Only use the charging cable/power adapter included with readers. Do not use reader if it is damaged, cracked, swelling… - Optium EZ Blood Glucose Monitoring System, UDI: 00093815710653
FDA Device · Class II · 2020-04-01 · Abbott Diabetes Care
Reason: Instructions sent in a letter or in instructions for use for disinfecting blood glucose and/or ketone meters were distributed but not cleared by the U.S. FDA, and devices were not cleared for multiple-patient use. Instr… - Precision Xtra Blood Glucose & Ketone Monitoring System, UDI: 00093815715023, 00093815988144
FDA Device · Class II · 2020-04-01 · Abbott Diabetes Care
Reason: Instructions sent in a letter or in instructions for use for disinfecting blood glucose and/or ketone meters were distributed but not cleared by the U.S. FDA, and devices were not cleared for multiple-patient use. Instr… - FreeStyle Precision H Blood Glucose and Ketone Monitoring System, UDI: 00093815711810
FDA Device · Class II · 2020-04-01 · Abbott Diabetes Care
Reason: Instructions sent in a letter or in instructions for use for disinfecting blood glucose and/or ketone meters were distributed but not cleared by the U.S. FDA, and devices were not cleared for multiple-patient use. Instr… - FreeStyle Blood Glucose Monitors System
FDA Device · Class I · 2014-03-26 · Abbott Diabetes Care
Reason: Abbott Diabetes Care has identified through internal testing and investigation that all non-applied voltage legacy meters have the potential to produce out of range control solution results and/or erroneously low blood… - FreeStyle Flash Blood Glucose Monitors System
FDA Device · Class I · 2014-03-26 · Abbott Diabetes Care
Reason: Abbott Diabetes Care has identified through internal testing and investigation that all non-applied voltage legacy meters have the potential to produce out of range control solution results and/or erroneously low blood… - FreeStyle Lite Blood Glucose Test Strips
FDA Device · Class I · 2013-12-25 · Abbott Diabetes Care
Reason: Certain lots of FreeStyle and FreeStyle Lite Blood Glucose Test Strips produce erroneously low blood glucose results when using FreeStyle Blood Glucose Meters, FreeStyle Flash Blood Glucose Meters and the FreeStyle bloo… - FreeStyle Blood Glucose Test Strips
FDA Device · Class I · 2013-12-25 · Abbott Diabetes Care
Reason: Certain lots of FreeStyle and FreeStyle Lite Blood Glucose Test Strips produce erroneously low blood glucose results when using FreeStyle Blood Glucose Meters, FreeStyle Flash Blood Glucose Meters and the FreeStyle bloo… - FreeStyle InsuLinx Blood Glucose Monitoring System: For In Vitro Diagnostic Use only
FDA Device · Class I · 2013-05-15 · Abbott Diabetes Care
Reason: AT rare, extremely high glucose levels (1024 mg/dL and above), the FreeStyle InsuLinx Blood Glucose Meter may provide an inaccurate reading.