Has Abbott had product recalls?

Yes, 9 recalls on file. See the full history below for each one.

Is this FDA enforcement data for Abbott 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 had?

Argus HQ has recorded 9 FDA events for Abbott: 0 warning letters, 9 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.

What is the most recent FDA action against Abbott?

The most recent FDA event Argus HQ has on file for Abbott is dated 2025-10-22, with a severity rating of "critical" in Argus HQ's classification. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

Abbott — FDA Enforcement History

FDA action counts

Total FDA actions	9
Warning letters	0
Recalls	9
Approval records	0
Form 483 inspection citations	0
Most recent action	October 22, 2025

In short: Argus HQ has recorded 9 FDA events for Abbott: 0 warning letters, 9 recalls, 0 approvals, and 0 inspection 483 observations. These events span from 2023-07-19 to 2025-10-22. 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.

Risk pattern analysis

Argus HQ analysis — not an FDA finding

This section is Argus HQ analysis, not an FDA finding. Abbott has 9 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 2025-10-22, Argus HQ recorded an FDA recall for Abbott, rated "critical" severity in Argus HQ's classification: Abbott — Class I recall: TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), REF…. On 2025-10-22, Argus HQ recorded an FDA recall for Abbott, rated "critical" severity in Argus HQ's classification: Abbott — Class I recall: TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, F, (UniD Curve F), REF A…. On 2025-10-22, Argus HQ recorded an FDA recall for Abbott, rated "critical" severity in Argus HQ's classification: Abbott — Class I recall: TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, D, (UniD Curve D), REF A…. On 2025-10-22, Argus HQ recorded an FDA recall for Abbott, rated "critical" severity in Argus HQ's classification: Abbott — Class I recall: TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DD, (BiD Curve D-D), REF…. On 2025-10-22, Argus HQ recorded an FDA recall for Abbott, rated "critical" severity in Argus HQ's classification: Abbott — Class I recall: TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DF, (BiD Curve D-F), REF…. On 2025-04-30, Argus HQ recorded an FDA recall for Abbott, rated "high" severity in Argus HQ's classification: Abbott — Class II recall: Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080. On 2025-04-30, Argus HQ recorded an FDA recall for Abbott, rated "high" severity in Argus HQ's classification: Abbott — Class II recall: Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVL…. On 2023-11-08, Argus HQ recorded an FDA recall for Abbott, rated "high" severity in Argus HQ's classification: Abbott — Class II recall: Abbott NT2000iX Radiofrequency (RF) generator, REF RFG-NT-2000, lesioning genera…. On 2023-07-19, Argus HQ recorded an FDA recall for Abbott, rated "critical" severity in Argus HQ's classification: Abbott — Class I recall: Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percut….

Frequently asked questions

Has Abbott had product recalls?: Yes, 9 recalls on file. See the full history below for each one.
Is this FDA enforcement data for Abbott 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 had?: Argus HQ has recorded 9 FDA events for Abbott: 0 warning letters, 9 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.
What is the most recent FDA action against Abbott?: The most recent FDA event Argus HQ has on file for Abbott is dated 2025-10-22, with a severity rating of "critical" in Argus HQ's classification. 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: Oct 22, 2025

Cite this record

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

APA

Argus HQ Research (2025). Abbott — FDA Enforcement History. Digital Empire LLC. Retrieved from https://argushq.ai/company/abbott

MLA

"Abbott — FDA Enforcement History." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/company/abbott.

Chicago

Argus HQ Research. "Abbott — FDA Enforcement History." Digital Empire LLC. Accessed July 17, 2026. https://argushq.ai/company/abbott.

BibTeX

@misc{argushq_argushq_ai_company_abbott_2025,
  title = {Abbott — FDA Enforcement History},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/company/abbott},
  note = {Accessed: July 17, 2026}
}

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