RegWardenFDA facility compliance records
Company

Gentuity, LLC

1 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2026: 1 recalls20172018201920202021202220232024202512026
  • Recalls (1)

Registered facilities (2)

Recalls & enforcement

  • Class IIOngoing2026-03-23
    The potential for repeated frames during HF-OCT pullback when using the Gentuity HF-OCT Console (software version 21.11 to 23.3.13) with the Vis-Rx and Vis-Rx Prime catheters. This correction is intended to ensure that users are fully informed of how to recognize, avoid, and miti…

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “Gentuity, LLC — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10073861-gentuity-llc/

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