Fusion Pro 24 — Class II medical device recall Z-0524-2025
Ongoing recall by Epilog Laser Corp., reported 2024-12-11, distributed nationwide. a. A small number of Fusion Pro 24 units were released with an incorrectly placed Interlock device. As a resul
| Recall number | Z-0524-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | FDA mandated |
| Recalling firm | Epilog Laser Corp., Golden, CO, United States |
| Recall initiated | 2024-08-08 |
| Classified | 2024-12-03 |
| Reported by FDA | 2024-12-11 |
| Distributed | Nationwide (US) |
| Quantity | 751 |
| Model numbers | 17000 |
Product
Fusion Pro 24, Model 17000
Reason for recall
a. A small number of Fusion Pro 24 units were released with an incorrectly placed Interlock device. As a result, the system can be operated with the front-loading door in an open position. b. Fails to comply with Class 2 designation, indicated in Part 6 of Laser Product Report. An incorrectly placed Interlock device can allow Class 4 laser radiation fields during operation.
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-0524-2025. 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.