DERMASENSOR INC: Device Recall
Recall #Z-0583-2026 · 10/13/2025
Class II: Risk
Recall Details
- Recall Number
- Z-0583-2026
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- DERMASENSOR INC
- Status
- Ongoing
- Date Initiated
- 10/13/2025
- Location
- Miami, FL, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 343 (9 units affected)
Reason for Recall
Potential for device to not meet specifications resulting in incorrect results or delay of referral for patients.
Product Description
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
Distribution Pattern
US distribution to MD, FL, AZ, MS, PA, NY, CT, CA.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.