Hialeah, FL, United States
Focalyx Technologies, LLC. recalls
1 recall recorded since 2018, most recently on 23 December 2025. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 23 December 2025
- Reason
- 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.
- Distribution
- Worldwide - US Nationwide distribution in the states of NY, MA, FL and the countries of ES, VE, DO.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1243-2026
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.