The Recall Desk
HighFDA (Devices)·Z-1243-2026·Announced 2026-02-11

[pending] Focalyx Fusion

Pending LLM rewrite. Source: FDA_DEVICE Z-1243-2026.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

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.

The recalled product

Product
Focalyx Fusion
Manufacturer
Focalyx Technologies, LLC.
Category
Medical Device — Devices

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distributed nationwide across the United States.

Related recalls

Same category