New York, NY, United States
Inova Lasers LLC recalls
1 recall recorded since 2018, most recently on 29 January 2020. 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
- 29 January 2020
- Reason
- The firm failed to comply with the applicable standards regarding Electronic Product Radiation Control (EPRC) regulations associated with the laser product performance standard and certification.
- Distribution
- US Nationwide Distribution
- Initiated
- FDA Mandated
- Recall number
- Z-0440-2021
- Class IV New Era medical laser device
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.