Class II — IDS LTD
| Recalling firm | IDS CO, LTD |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | The Smaxel Fractional CO2 Laser does not include a Certification label, and adequate instructions for safe operation of the device. |
| Product | Smaxel Fractional CO2 Laser, a Class IV medical laser system. |
| Quantity | 23 |
| Distribution | Worldwide - US Nationwide Distribution |
| Initiated | 2024-10-16 |
| Classified | 2025-01-07 |
| Recall number | Z-0804-2025 |
| Initiation | FDA Mandated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — IDS LTD (Z-0804-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/96034/
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