Brand
Focalyx
1 federal recall on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Focalyx and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-02-11FDA-DeviceClass IIStop using Focalyx Fusion software
Software device that is an accessory for image-guided interventional and diagnostic procedures involving prostate has accessories that may not function properly with Windows 10, which may cause patient harm during biopsy or cause treatment/therapy delays, so firm is recommending stop use until device is verified/validated with Windows 11.
Get notified about new Focalyx recalls
Free weekly digest. We email when a new federal recall affects Focalyx or anything else in your household.
Get the Sunday BriefExplore other recall topics
By hazard
By state