San Juan Capistrano, CA, United States
DermLite LLC recalls
1 recall recorded since 2018, most recently on 20 March 2023. 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
- 20 March 2023
- Reason
- Incorrect labeling; Package labeling contains a different serial number then the serial number on the product labeling.
- Distribution
- Worldwide - US Nationwide distribution in the states of CA, AZ, TX, FL, NE, IA, MO, CO and the countries of Saudi Arabia, Australia, Spain.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1506-2023
- DERMLITE DL4W, REF: DL4W, Rx Only MD, CE
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.