Abbott Diabetes Care, Inc. recalls
9 recalls in our records from 2013 to 2026: 9 FDA medical devices.
Recalls with full detail pages
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Abbott Diabetes Care, Inc. medical device recall: FreeStyle Libre 3 Sensor REF 72081-01 UDI-DI code: 00357599818005 The…
Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results
Earlier and other recalls
These link to the official agency notice.
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Abbott Diabetes Care, Inc. medical device recall: FreeStyle Libre 3 Sensors Official notice ↗
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…
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Abbott Diabetes Care, Inc. medical device recall: FreeStyle Libre 3 App Official notice ↗
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…
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Abbott Diabetes Care, Inc. medical device recall: FreeStyle Libre 2 Readers Official notice ↗
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…
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Abbott Diabetes Care, Inc. medical device recall: FreeStyle Libre Reader Official notice ↗
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…
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Abbott Diabetes Care, Inc. medical device recall: Precision Xtra Blood Glucose & Ketone Monitoring System Official notice ↗
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…
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Abbott Diabetes Care, Inc. medical device recall: FreeStyle Blood Glucose Monitors System. For in vitro diagnostic use… Official notice ↗
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…
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Abbott Diabetes Care, Inc. medical device recall: FreeStyle Blood Glucose Test Strips Official notice ↗
Certain lots of FreeStyle and FreeStyle Lite Blood Glucose Test Strips produce erroneously low blood glucose results when using FreeStyle Blood Glucose Meters, FreeStyle…
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Abbott Diabetes Care, Inc. medical device recall: FreeStyle InsuLinx Blood Glucose Monitoring System: For In Vitro… Official notice ↗
AT rare, extremely high glucose levels (1024 mg/dL and above), the FreeStyle InsuLinx Blood Glucose Meter may provide an inaccurate reading.
Firm names are matched across agencies by name only. Different companies with similar names may be grouped together; check each official notice.