Brand
Gentuity
1 federal recall on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Gentuity and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-04-22FDA-DeviceClass IICheck Gentuity HF-OCT system software version
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.
Get notified about new Gentuity recalls
Free weekly digest. We email when a new federal recall affects Gentuity or anything else in your household.
Get the Sunday BriefExplore other recall topics
By hazard
By state