Quick Facts at a Glance
- Recall Date
- December 23, 2025
- Hazard Level
- HIGH
- Brand
- Focalyx Technologies
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Focalyx Technologies
- Product type
- Software Device
- Model numbers
- 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 +12 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 23, 2025
Reported by FDA DEVICE
February 11, 2026
RecallRadar source check
February 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Focalyx Technologies, LLC. or your healthcare provider for instructions. Notification method: Letter
About This Product
Focalyx Fusion is a software device used as an accessory for image-guided interventional and diagnostic procedures concerning prostate health. It is typically utilized in medical settings to assist in biopsy procedures and other diagnostic functions.
Why This Is Dangerous
This device may not operate properly with Windows 10, which could lead to significant risks during medical procedures such as biopsies. Such malfunctions could delay treatment and lead to adverse patient outcomes.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients and healthcare providers may face delays in procedures, which could impact treatment schedules and health outcomes.
Practical Guidance
How to identify if yours is affected
- Check the device's software version and serial number against the recall list.
- Verify if the software is running on Windows 10.
- Contact your healthcare provider for confirmation if unclear.
Where to find product info
Serial numbers and software versions can typically be found on the device's packaging or user manual.
What timeline to expect
Expect a refund or replacement to be processed within 4-6 weeks after your request.
If the manufacturer is unresponsive
- Follow up with Focalyx Technologies via phone or email.
- Document all interactions and responses.
How to prevent similar issues
- Ensure compatibility with the latest software before purchasing medical devices.
- Check for recalls and safety updates regularly.
Documentation advice
Keep a record of any communications with the manufacturer and retain all documentation related to the recall.
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Product Details
The Focalyx Fusion software device is designed for image-guided interventional and diagnostic procedures involving the prostate. The recall affects 18 units distributed worldwide, including New York, Massachusetts, Florida, Spain, Venezuela, and the Dominican Republic.
Key Facts
- Recall date: December 23, 2025
- Reported date: February 11, 2026
- Total quantity recalled: 18
- Device may malfunction with Windows 10
- Potential risk: patient harm during procedures
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