Class II

Medical Device Recall: 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

DERMASENSOR INC · October 13, 2025

Reason for Recall

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.

States Affected

AZ, CA, CT, FL, MD, MS, NY, PA

Quantity Affected

343 (9 units affected)

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0583-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

DERMASENSOR INC Medical Device Recall: 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 | SafeCheck