Boulder, CO, United States
Accure Acne, Inc recalls
1 recall recorded since 2018, most recently on 6 December 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
- 6 December 2023
- Reason
- Laser system's spot tracking system may become misaligned resulting in the possible risk of delivery of higher-than-expected laser energy to epidermal tissue, which may cause blistering.
- Distribution
- US distribution to states of: CO, CA, CT, NY, NJ, MN, LA, OH, MA, TX
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0778-2024
- Accure Laser System, Model: PFMS00004
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.