Miami, FL, United States
DERMASENSOR INC recalls
1 recall recorded since 2018, most recently on 13 October 2025. 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
- 13 October 2025
- Reason
- Potential for device to not meet specifications resulting in incorrect results or delay of referral for patients.
- Distribution
- US distribution to MD, FL, AZ, MS, PA, NY, CT, CA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0583-2026
- DermaSensor. Model/Catalog Number: 10101. Software Version: 3.0.2. Software-aided adjunctive diagnostic device for use by physicians on lesions suspicious for skin cancer
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.