Gentuity, LLC — FDA Compliance Timeline

FDA action counts

Enforcement history

On 2026-04-22, Argus HQ recorded an FDA recall for Gentuity, LLC, rated "high" severity in Argus HQ's classification: Gentuity, LLC — Class II recall: Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13;. 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. 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. Gentuity, LLC has 1 FDA event on file. 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.

Frequently asked questions

Does Argus HQ track new FDA actions for Gentuity, LLC automatically?

Yes. Argus HQ ingests FDA sources daily, including FDA warning letters, recalls, drug and biologic approvals, and Form 483 inspection observations. When a new FDA action linked to Gentuity, LLC is observed, this page's event count and history update automatically.

How many FDA actions does Argus HQ track for Gentuity, LLC?

1 total: 0 warning letters, 1 recall, 0 approval records, and 0 Form 483 inspection citations.

What is the most recent FDA action on file for Gentuity, LLC?

April 22, 2026. Argus HQ ingests new FDA enforcement records daily.

Has Gentuity, LLC had product recalls?

Yes, 1 recall on file. See the full history below for each one.

Related enforcement actions

• Gentuity, LLC — Class II recall: Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13; →

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