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RecallWatchMedical Device Safety
Class IIOngoingZ-1243-2026

Focalyx Technologies, LLC. recalls Focalyx Fusion

Focalyx Technologies, LLC.Hialeah, FL, United StatesReported Feb 11, 2026 · 5 months ago
Legal News Analyst ·

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • Focalyx FusionUDI-DI
    UDI-DI 00860003552001.
    18 affected lots
    IF-FF-B-1-22080504IF-FF-B-1-TPAA998118IF-FF-B-1-351238IF-FF-B-1-TPAB081335IF-FF-B-1-22080508IF-FF-B-1-TPAB200331IF-FF-B-1-TPAB200333IF-FF-B-1-TPAC505383
    +10 moreIF-FF-B-1-TPAB200348IF-FF-B-1-TPAB540364IF-FF-B-1-S5ARQL009253NYZIF-FF-B-1-SCARQL0014096YZIF-FF-B-1-TPAB532163IF-FF-B-1-SCARQL00136033KKIF-FF-B-1-TPAB540359IF-FF-B-1-TPAB081326IF-FF-B-1-22080505IF-FF-B-1-TPAB081324

What the firm is doing

On 12/23/2025, correction notices started being emailed to customers informing them of the following: You will be contacted to schedule installation of the new version. An IFU will be provided at time of installation. Complete and return the response form via email to corporate@focalyx.com If there are any questions, contact the firm at: focalyxtechnologies.com/contact, support@focalyxtechnologies.com, (888) 636 2259, (Sel. 3 Technical Support)

DistributionShow details

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

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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