What is the current status of this recall?

Status as recorded by FDA: Completed.

Where can I verify this recall directly with FDA?

The verbatim FDA record is the source of truth for every recall Argus HQ tracks — always confirm against fda.gov before acting.

FDA Recall Database: Class II Recall: FreeStyle Libre 3 App, part of Continuous Glucose… by Abbott Diabetes Care, Inc.

FDA classified a recall by Abbott Diabetes Care, Inc. as Class II, reported 20240124. The affected product is FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Android 13 Operating System (recall number Z-0734-2024). Reason for recall: 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 could lead to undetected low or high glucose, which could result in delayed treatment: not taking insulin (for high glucose), or not taking glucose (for low glucose) when required.. Status: Completed.

Key facts

Recalling firm	Abbott Diabetes Care, Inc.
Manufacturer	Not disclosed in the FDA record.
Brand name	Not disclosed in the FDA record.
Product description	FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Android 13 Operating System
Classification	Class II
Recall number	Z-0734-2024
Report date	Not disclosed in the FDA record.
Status	Completed
Reason for recall	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 could lead to undetected low or high glucose, which could result in delayed treatment: not taking insulin (for high glucose), or not taking glucose (for low glucose) when required.

What consumers should do

Facilities, clinicians, and consumers holding an affected unit or lot of FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Android 13 Operating System should stop using it for the purpose described in the recall notice and hold remaining stock pending instructions from Abbott Diabetes Care, Inc.. FDA recall records typically direct the recalling firm to notify known accounts directly with a recall letter describing the specific corrective action -- replacement, field correction, refund, or return. Anyone who received the product through a distributor rather than directly from Abbott Diabetes Care, Inc. should confirm with their supplier whether their specific lot or unit is on the affected list, since recall notices are lot- or unit-specific and not every unit of a product line is necessarily included. Questions about a specific unit's status should go to Abbott Diabetes Care, Inc. directly or to the distributor that supplied it; Argus HQ is a public-record aggregator, not the recalling firm, and cannot confirm individual unit status.

What this classification means

A Class II recall is FDA’s middle classification. FDA assigns Class II when use of, or exposure to, the recalled product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. FDA still requires the recalling firm to notify affected accounts and submit status reports on the correction, though the monitoring intensity is lower than for a Class I recall. FDA's Center for Devices and Radiological Health (for devices) or Center for Drug Evaluation and Research (for drugs) reviews the classification and can require additional corrective action if the initial response is judged insufficient. Because this record is filed as Class II, professionals and consumers handling an affected lot should treat FDA's own classification -- not this page's summary of it -- as the authoritative risk signal. A Class I recall is FDA’s most serious classification. FDA assigns Class I when there is a reasonable probability that use of, or exposure to, the recalled product will cause serious adverse health consequences or death. This classification does not mean harm has already occurred in every case -- it reflects FDA’s assessment of the realistic worst-case risk profile of the defect described in the recall, based on the reason for recall reported by the firm. Class I recalls receive the closest FDA monitoring of the three classes: the recalling firm typically must submit a recall strategy, periodic status reports, and effectiveness checks confirming that the affected lots have actually been removed from distribution or corrected in the field.

Abbott Diabetes Care, Inc.’s FDA history

Argus HQ has recorded 10 total FDA actions tied to Abbott Diabetes Care, Inc.: 0 warning letters, 10 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

What is the current status of this recall?: Status as recorded by FDA: Completed.
Where can I verify this recall directly with FDA?: The verbatim FDA record is the source of truth for every recall Argus HQ tracks — always confirm against fda.gov before acting.
Is FreeStyle Libre 3 App, part of Continuous Glucose Monitoring recalled?: Yes. FDA lists a Class II recall by Abbott Diabetes Care, Inc. for FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Android 13 Operating System, reported 20240124, with status "Completed." FDA recall number: Z-0734-2024.
What is the recall class for Abbott Diabetes Care, Inc.'s recall?: FDA classified this recall as Class II. A Class II recall is FDA’s middle classification. FDA assigns Class II when use of, or exposure to, the recalled product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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Full FDA history for Abbott Diabetes Care, Inc.

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2024). FDA Recall Database: Class II Recall: FreeStyle Libre 3 App, part of Continuous Glucose… by Abbott Diabetes Care, Inc.. Digital Empire LLC. Retrieved from https://argushq.ai/recall/abbott-diabetes-care-z-0734-2024-2024-01-24

MLA

"FDA Recall Database: Class II Recall: FreeStyle Libre 3 App, part of Continuous Glucose… by Abbott Diabetes Care, Inc.." Argus HQ Research, Digital Empire LLC, 2024, argushq.ai/recall/abbott-diabetes-care-z-0734-2024-2024-01-24.

Chicago

Argus HQ Research. "FDA Recall Database: Class II Recall: FreeStyle Libre 3 App, part of Continuous Glucose… by Abbott Diabetes Care, Inc.." Digital Empire LLC. Accessed July 17, 2026. https://argushq.ai/recall/abbott-diabetes-care-z-0734-2024-2024-01-24.

BibTeX

@misc{argushq_argushq_ai_recall_abbott_diabetes_care_z_0734_2024_2024_01_24_2024,
  title = {FDA Recall Database: Class II Recall: FreeStyle Libre 3 App, part of Continuous Glucose… by Abbott Diabetes Care, Inc.},
  author = {{Argus HQ Research}},
  year = {2024},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/recall/abbott-diabetes-care-z-0734-2024-2024-01-24},
  note = {Accessed: July 17, 2026}
}

Source: FDA.gov — Recalls ↗