Paju, Korea (the Republic of)
IDS LTD recalls
1 recall recorded since 2018, most recently on 16 October 2024. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 16 October 2024
- Reason
- The Smaxel Fractional CO2 Laser does not include a Certification label, and adequate instructions for safe operation of the device.
- Distribution
- Worldwide - US Nationwide Distribution
- Initiated
- FDA Mandated
- Recall number
- Z-0804-2025
- Smaxel Fractional CO2 Laser, a Class IV medical laser system.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.