FDA recall record · openFDA

Abbott Diabetes Care, Inc.

10 FDA recalls on record (2023–2025) — 10 device. 10 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low gluco 4

Lithium-ion batteries in glucose monitoring system readers may swell, overheat, or pose fire hazard. Only use the chargi 3

Users of the FreeStyle Libre 3 sensors reported situations where they were receiving erroneously high glucose results. T 1

If blood glucose monitoring system users attempt to start a new sensor, when the old sensor wasn't used for the full 14- 1

If using affected glucose monitoring app on Android 13 Operating System, extended periods of signal loss may be experien 1

Recalls

FreeStyle Libre 3 Sensor REF 72081-01 UDI-DI code: 00357599818005 The FreeStyle Libre 3 sensor is a component of the Fr Class I 2025-11-24 FreeStyle Libre 3 Plus Sensor REF 78768-01 UDI-DI code: 00357599844011 The FreeStyle Libre 3 Plus sensor is a component Class I 2025-11-24 FreeStyle Libre 3 Plus Sensor REF 78769-01 UDI-DI code: 00357599843014 The FreeStyle Libre 3 Plus sensor is a component Class I 2025-11-24 FreeStyle Libre 3 Plus Sensor REF 72080-01 UDI-DI code: 00357599819002 The FreeStyle Libre 3 Plus sensor is a component Class I 2025-11-24 FreeStyle Libre 3 Sensors, REF: 72081-01, component of the FreeStyle Libre 3 Continuous Glucose Monitoring System Class I 2024-07-24 FreeStyle Libre Reader, REF: 71951-01, 71952-01, 71953-01 a component of the FreeStyle Libre 2 Flash Glucose Monitoring Class I 2023-02-13 FreeStyle Libre Reader, REF: 71936-01, 71937-01, 71938-01 a component of the FreeStyle Libre 14 Day Flash Glucose Monito Class I 2023-02-13 FreeStyle Libre Reader, REF: 71525-01, 71701-01, 71739-01 a component of the FreeStyle Libre Flash Glucose Monitoring Sy Class I 2023-02-13 FreeStyle Libre 2 Readers, REF: 71951-01 and 71953-01, used with FreeStyle Libre 2 System Class II 2023-07-12 FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Android 13 Operating System Class II 2023-02-09

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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