How many FDA warning letters has Gentuity, LLC received?

Argus HQ has not recorded an FDA warning letter for Gentuity, LLC in our current dataset.

What FDA recalls has Gentuity, LLC issued?

Argus HQ has recorded 1 FDA recall tied to Gentuity, LLC.

Is Gentuity, LLC FDA compliant?

Argus HQ is not a compliance rating service. As of this page's last update, our dataset shows 0 warning letters, 1 recall, and 0 approval records for Gentuity, LLC. Review the linked FDA source records directly before drawing a compliance conclusion.

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company

Gentuity, LLC

Name: FDA Enforcement Actions Against Gentuity, LLC
Creator: Argus HQ
License: https://argushq.ai/methodology

Jurisdiction: US

FDA Warning Letter timeline

V1 scope: FDA Warning Letters only. Additional public-record sources (SEC, CPSC, federal contracts) are on the V2 roadmap and are not surfaced here today.

fda_recall · device_recall2026-04-22
Gentuity, LLC — Class II recall: Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13;

Frequently asked questions

How many FDA warning letters has Gentuity, LLC received?: Argus HQ has not recorded an FDA warning letter for Gentuity, LLC in our current dataset.
What FDA recalls has Gentuity, LLC issued?: Argus HQ has recorded 1 FDA recall tied to Gentuity, LLC.
Is Gentuity, LLC FDA compliant?: Argus HQ is not a compliance rating service. As of this page's last update, our dataset shows 0 warning letters, 1 recall, and 0 approval records for Gentuity, LLC. Review the linked FDA source records directly before drawing a compliance conclusion.

Informational only. FDA Warning Letters are public records (17 USC §105). Summaries are AI-assisted and may contain errors; always verify against the original FDA letter before acting. Not legal, financial, or regulatory advice.