Smaxel Fractional CO2 Laser — Class II medical device recall Z-0804-2025
Ongoing recall by IDS LTD, reported 2025-01-15, distributed nationwide. The Smaxel Fractional CO2 Laser does not include a Certification label, and adequate instructions for safe ope
| Recall number | Z-0804-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | FDA mandated |
| Recalling firm | IDS LTD, Paju, Korea (the Republic of) |
| Recall initiated | 2024-10-16 |
| Classified | 2025-01-07 |
| Reported by FDA | 2025-01-15 |
| Distributed | Nationwide (US) |
| Quantity | 23 |
| Reason classes | labeling |
Product
Smaxel Fractional CO2 Laser, a Class IV medical laser system.
Reason for recall
The Smaxel Fractional CO2 Laser does not include a Certification label, and adequate instructions for safe operation of the device.
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-0804-2025. 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.