Focalyx Technologies, LLC. recalls Focalyx Fusion

Recalling company

Focalyx Technologies, LLC.

Product

Focalyx Fusion

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.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Dec 23, 2025

Reported

Feb 11, 2026

Distribution

Worldwide - US Nationwide distribution in the states of NY, MA, FL and the countries of ES, VE, DO.

Status

Ongoing

Quantity

18

Lot / codes

UDI-DI: 00860003552001. Software Versions: 1.3, 1.5, 1.6. Serial Numbers: IF-FF-B-1-22080504, IF-FF-B-1-TPAA998118, IF-FF-B-1-351238, IF-FF-B-1-TPAB081335, IF-FF-B-1-22080508, IF-FF-B-1-TPAB200331, IF-FF-B-1-TPAB200333, IF-FF-B-1-TPAC505383, IF-FF-B-1-TPAB200348, IF-FF-B-1-TPAB540364, IF-FF-B-1-S5ARQL009253NYZ, IF-FF-B-1-SCARQL0014096YZ, IF-FF-B-1-TPAB532163, IF-FF-B-1-SCARQL00136033KK, IF-FF-B-1-TPAB540359, IF-FF-B-1-TPAB081326, IF-FF-B-1-22080505, IF-FF-B-1-TPAB081324

Company location

Hialeah, FL

Recall type

Voluntary: Firm initiated

Recall number

Z-1243-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-1243-2026 in the FDA Enforcement Report. Also see FDA recall press releases.