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

Focalyx Fusion

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

Severity not yet assessed

We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.

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

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