FDA Device recall Z-0804-2025
Smaxel Fractional CO2 Laser, a Class IV medical laser system
- FDA Device
- Class II
- ongoing
- Published 2025-01-15
On 2025-01-15 the FDA classified a Class II recall of Smaxel Fractional CO2 Laser, a Class IV medical laser system by Ids, citing the Smaxel Fractional CO2 Laser does not include a Certification label, and adequate instructions for safe operation of the device.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0804-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-10-16 |
| Published | 2025-01-15 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Ids |
| Distribution | US |
Product
Smaxel Fractional CO2 Laser, a Class IV medical laser system.
Reason
The Smaxel Fractional CO2 Laser does not include a Certification label, and adequate instructions for safe operation of the device.
Identifiers
| code_info | unknown |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0804-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.