DERMASENSOR INC recalls DermaSensor.
- Recalling company
- DERMASENSOR INC
- Product
- 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
- Reason
- Potential for device to not meet specifications resulting in incorrect results or delay of referral for patients.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Oct 13, 2025
- Reported
- Dec 3, 2025
- Distribution
- US distribution to MD, FL, AZ, MS, PA, NY, CT, CA.
- Status
- Ongoing
- Quantity
- 343 (9 units affected)
- Lot / codes
- Lot Code: Model No 10101; UDI-DI 085001778610101A9; Serial Number 1010120241230196E4E, 1010120241240151FD5, 101012024130014EF69, 101012024125014F595, 10101202413001F7C66, 1010120242400172717, 101012024325014CE26, 10101202433101D295C, 101012025093012EE03.
- Company location
- Miami, FL
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-0583-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-0583-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.