Focalyx Technologies, LLC.: Medical Device Recall in 2026 - (Recall #: Z-1243-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2026.

Data Source: FDA.

Product Description:

Focalyx Fusion

Product Classification:

Class II

Date Initiated: December 23, 2025

Date Posted: February 11, 2026

Recall Number: Z-1243-2026

Event ID: 98137

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 18

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated