Has Abbott Diabetes Care, Inc. had other FDA enforcement actions?

Yes. 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.

What kind of FDA record is this?

This is an Argus HQ record of a FDA Recall, tagged high severity by Argus HQ. FDA published the underlying record on 2023-08-23; Argus observed and indexed it on 2026-07-16.

Where can I verify this record directly with FDA?

The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

.hq

fda_recall · device_recall · high

Abbott Diabetes Care, Inc. — Class II recall: FreeStyle Libre 2 Readers, REF: 71951-01 and 71953-01, used with FreeStyle Libre…

Name: FDA Recall Record — Abbott Diabetes Care, Inc.
Creator: Argus HQ
Published: 2023-08-23
License: https://argushq.ai/methodology

Event date: 2023-08-23 00:00:00Z
Observed: 2026-07-16 23:20:09Z
Source ID: Z-2414-2023
Payload hash: 1f55e8663127d4a8e19d9bfd…

Summary

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 previous sensor, or FreeStyle Libre 2 app, or the sensor's full wear time hasn't e… Status: Ongoing.

Entities

Abbott Diabetes Care, Inc.

View source record ↗

Frequently asked questions

Has Abbott Diabetes Care, Inc. had other FDA enforcement actions?: Yes. 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.
What kind of FDA record is this?: This is an Argus HQ record of a FDA Recall, tagged high severity by Argus HQ. FDA published the underlying record on 2023-08-23; Argus observed and indexed it on 2026-07-16.
Where can I verify this record directly with FDA?: The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

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 (2023). Abbott Diabetes Care, Inc. — Class II recall: FreeStyle Libre 2 Readers, REF: 71951-01 and 71953-01, used with FreeStyle Libre…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-abbott-diabetes-care-inc-z-2414-2023

MLA

"Abbott Diabetes Care, Inc. — Class II recall: FreeStyle Libre 2 Readers, REF: 71951-01 and 71953-01, used with FreeStyle Libre…." Argus HQ Research, Digital Empire Holdings LLC, 2023, argushq.ai/events/fda-recall-abbott-diabetes-care-inc-z-2414-2023.

Chicago

Argus HQ Research. "Abbott Diabetes Care, Inc. — Class II recall: FreeStyle Libre 2 Readers, REF: 71951-01 and 71953-01, used with FreeStyle Libre…." Digital Empire Holdings LLC. Accessed July 23, 2026. https://argushq.ai/events/fda-recall-abbott-diabetes-care-inc-z-2414-2023.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_abbott_diabetes_care_inc_z_2414_2023_2023,
  title = {Abbott Diabetes Care, Inc. — Class II recall: FreeStyle Libre 2 Readers, REF: 71951-01 and 71953-01, used with FreeStyle Libre…},
  author = {{Argus HQ Research}},
  year = {2023},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-abbott-diabetes-care-inc-z-2414-2023},
  note = {Accessed: July 23, 2026}
}

Informational only. Not legal, financial, or medical advice.