What is the most recent FDA action on file for Abbott Diabetes Care, Inc.?

January 21, 2026. Argus HQ ingests new FDA enforcement records daily.

Has Abbott Diabetes Care, Inc. had product recalls?

Yes, 10 recalls on file. See the full history below for each one.

Is this FDA enforcement data for Abbott Diabetes Care, Inc. official?

Every record links directly to its primary FDA.gov source. Argus HQ aggregates and structures public FDA data; the verbatim FDA record is always the source of truth.

How many FDA actions has Abbott Diabetes Care, Inc. had?

Argus HQ has recorded 10 FDA events for Abbott Diabetes Care, Inc.: 0 warning letters, 10 recalls, 0 approvals, and 0 Form 483 inspection observations. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

FDA Enforcement History: Abbott Diabetes Care, Inc.

At a glance: Argus HQ has recorded 10 FDA events for Abbott Diabetes Care, Inc.: 0 warning letters, 10 recalls, 0 approvals, and 0 inspection 483 observations. These events span from 2023-04-12 to 2026-01-21. The most severe rating Argus HQ has assigned across this history is "critical". Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed.

FDA action counts

Total FDA actions	10
Warning letters	0
Recalls	10
Approval records	0
Form 483 inspection citations	0
Most recent action	January 21, 2026

Risk pattern analysis

Argus HQ analysis — not an FDA finding

This section is Argus HQ analysis, not an FDA finding. Abbott Diabetes Care, Inc. has 10 separate FDA recalls on file, more than a single isolated recall event. A pattern across multiple FDA touchpoints does not by itself establish that any specific product currently poses a risk; it reflects only the frequency of FDA engagement with this company as recorded in Argus HQ's database. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ does not independently verify FDA's underlying findings; this page summarizes what FDA has published and links back to the original FDA source for each event. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

Enforcement history

On 2026-01-21, Argus HQ recorded an FDA recall for Abbott Diabetes Care, Inc., rated "critical" severity in Argus HQ's classification: Abbott Diabetes Care, Inc. — Class I recall: FreeStyle Libre 3 Plus Sensor REF 78769-01 UDI-DI code: 00357599843014 The Free…. On 2026-01-21, Argus HQ recorded an FDA recall for Abbott Diabetes Care, Inc., rated "critical" severity in Argus HQ's classification: Abbott Diabetes Care, Inc. — Class I recall: FreeStyle Libre 3 Sensor REF 72081-01 UDI-DI code: 00357599818005 The FreeStyle…. On 2026-01-21, Argus HQ recorded an FDA recall for Abbott Diabetes Care, Inc., rated "critical" severity in Argus HQ's classification: Abbott Diabetes Care, Inc. — Class I recall: FreeStyle Libre 3 Plus Sensor REF 72080-01 UDI-DI code: 00357599819002 The Free…. On 2026-01-21, Argus HQ recorded an FDA recall for Abbott Diabetes Care, Inc., rated "critical" severity in Argus HQ's classification: Abbott Diabetes Care, Inc. — Class I recall: FreeStyle Libre 3 Plus Sensor REF 78768-01 UDI-DI code: 00357599844011 The Free…. On 2024-09-04, Argus HQ recorded an FDA recall for Abbott Diabetes Care, Inc., rated "critical" severity in Argus HQ's classification: Abbott Diabetes Care, Inc. — Class I recall: FreeStyle Libre 3 Sensors, REF: 72081-01, component of the FreeStyle Libre 3 Con…. On 2024-01-24, Argus HQ recorded an FDA recall for Abbott Diabetes Care, Inc., rated "high" severity in Argus HQ's classification: Abbott Diabetes Care, Inc. — Class II recall: FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used o…. On 2023-08-23, Argus HQ recorded an FDA recall for Abbott Diabetes Care, Inc., rated "high" severity in Argus HQ's classification: Abbott Diabetes Care, Inc. — Class II recall: FreeStyle Libre 2 Readers, REF: 71951-01 and 71953-01, used with FreeStyle Libre…. On 2023-04-12, Argus HQ recorded an FDA recall for Abbott Diabetes Care, Inc., rated "critical" severity in Argus HQ's classification: Abbott Diabetes Care, Inc. — Class I recall: FreeStyle Libre Reader, REF: 71951-01, 71952-01, 71953-01 a component of the Fre…. On 2023-04-12, Argus HQ recorded an FDA recall for Abbott Diabetes Care, Inc., rated "critical" severity in Argus HQ's classification: Abbott Diabetes Care, Inc. — Class I recall: FreeStyle Libre Reader, REF: 71936-01, 71937-01, 71938-01 a component of the Fre…. On 2023-04-12, Argus HQ recorded an FDA recall for Abbott Diabetes Care, Inc., rated "critical" severity in Argus HQ's classification: Abbott Diabetes Care, Inc. — Class I recall: FreeStyle Libre Reader, REF: 71525-01, 71701-01, 71739-01 a component of the Fre….

Frequently asked questions

What is the most recent FDA action on file for Abbott Diabetes Care, Inc.?: January 21, 2026. Argus HQ ingests new FDA enforcement records daily.
Has Abbott Diabetes Care, Inc. had product recalls?: Yes, 10 recalls on file. See the full history below for each one.
Is this FDA enforcement data for Abbott Diabetes Care, Inc. official?: Every record links directly to its primary FDA.gov source. Argus HQ aggregates and structures public FDA data; the verbatim FDA record is always the source of truth.
How many FDA actions has Abbott Diabetes Care, Inc. had?: Argus HQ has recorded 10 FDA events for Abbott Diabetes Care, Inc.: 0 warning letters, 10 recalls, 0 approvals, and 0 Form 483 inspection observations. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

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

Verified from FDA.gov · Last updated: Jan 21, 2026

Cite this record

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

APA

Argus HQ Research (2026). FDA Enforcement History: Abbott Diabetes Care, Inc.. Digital Empire LLC. Retrieved from https://argushq.ai/company/abbott-diabetes-care-inc

MLA

"FDA Enforcement History: Abbott Diabetes Care, Inc.." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/company/abbott-diabetes-care-inc.

Chicago

Argus HQ Research. "FDA Enforcement History: Abbott Diabetes Care, Inc.." Digital Empire LLC. Accessed July 17, 2026. https://argushq.ai/company/abbott-diabetes-care-inc.

BibTeX

@misc{argushq_argushq_ai_company_abbott_diabetes_care_inc_2026,
  title = {FDA Enforcement History: Abbott Diabetes Care, Inc.},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/company/abbott-diabetes-care-inc},
  note = {Accessed: July 17, 2026}
}

Source: FDA.gov (aggregated across Warning Letters, Recalls, Approvals, Form 483s) ↗