Focalyx Fusion — Class II medical device recall Z-1243-2026
Ongoing recall by Focalyx Technologies, LLC., reported 2026-02-11, distributed nationwide. Software device that is an accessory for image-guided interventional and diagnostic procedures involving prost
| Recall number | Z-1243-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Focalyx Technologies, LLC., Hialeah, FL, United States |
| Recall initiated | 2025-12-23 |
| Classified | 2026-02-03 |
| Reported by FDA | 2026-02-11 |
| Distributed | Nationwide (US) |
| Quantity | 18 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00860003552001 |
| Serial numbers | IF-FF-B-1-22080504, IF-FF-B-1-22080505, IF-FF-B-1-22080508, IF-FF-B-1-351238, IF-FF-B-1-S5ARQL009253NYZ, IF-FF-B-1-SCARQL00136033KK, IF-FF-B-1-SCARQL0014096YZ, IF-FF-B-1-TPAA998118, IF-FF-B-1-TPAB081324, IF-FF-B-1-TPAB081326, IF-FF-B-1-TPAB081335, IF-FF-B-1-TPAB200331, IF-FF-B-1-TPAB200333, IF-FF-B-1-TPAB200348, IF-FF-B-1-TPAB532163, IF-FF-B-1-TPAB540359, IF-FF-B-1-TPAB540364, IF-FF-B-1-TPAC505383 |
Product
Focalyx Fusion
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1243-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.