Gentuity, LLC 2026-04-22 Health serious FDA
Health · FDA · Recall #FDA-Z-1823-2026
Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13; Recall
Issued April 22, 2026 · Gentuity, LLC
In April 2026, Gentuity, LLC recalled the Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13;, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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 mitigate this condition to maintain accurate longitudinal (length) measurements during OCT imaging.
What you should do
- 1 Stop using Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13; right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Gentuity, LLC to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Gentuity, LLC
- Category
- Health
- Recall date
- April 22, 2026
- Units affected
- Not reported
- Sold at
- Domestic - US Nationwide distribution in the states of CA, FL, GA, IL, MA, MN, NJ, NY, OH, PA, TX; International: United Arab Emirates, Bel
- Recall number
- FDA-Z-1823-2026
- Made in
- United States
- Issuing agency
- FDA
In context
- Gentuity, LLC has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 356th Health recall we've logged in 2026.