CLASS II ONGOING Device recall · Reported 11 Feb 2026 · FDA Enforcement Report
Focalyx Fusion recalled by Focalyx Technologies
Focalyx Technologies is recalling Focalyx Fusion, distributed nationwide in the US. The recall was initiated on 23 Dec 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1243-2026
- FDA event ID
- 98137
- Recalling firm
- Focalyx Technologies, Hialeah, FL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 23 Dec 2025
- FDA classified
- 3 Feb 2026
- Reported
- 11 Feb 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 23 Dec 2025 | Recall initiated by company | |
| 3 Feb 2026 | Classified by FDA | +42 days |
| 11 Feb 2026 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Focalyx Fusion
Where it was distributed
Worldwide - US Nationwide distribution in the states of NY, MA, FL and the countries of ES, VE, DO.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
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
Where was it sold?
Worldwide - US Nationwide distribution in the states of NY, MA, FL and the countries of ES, VE, DO.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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