FDA recall, , Moderate risk
Focalyx Technologies Focalyx Fusion
Focalyx Fusion is a software device for image-guided prostate procedures.
Summary by Recall Canary from the FDA notice
What happened
Focalyx Technologies, LLC, of Hialeah, Florida, recommended stopping use of the Focalyx Fusion software device, an accessory for image-guided interventional and diagnostic procedures involving the prostate, because its accessories may not function properly with Windows 10 and may cause patient harm during biopsy or cause treatment or therapy delays.
The company began the recall on December 23, 2025, and the FDA added it to the Enforcement Report on February 3, 2026. The device was distributed in the states of NY, MA, FL and the countries of ES, VE, DO.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
Focalyx Fusion
- UDI-DI
- 00860003552001
- 22080504
- 22080508
- 22080505
Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution in the states of New York, Massachusetts, Florida and the countries of ES, VE, DO.
- Company
- Focalyx Technologies, LLC.Hialeah, Florida
- Hazard
- Software defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98137
- Recall number
- Z-1243-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
