Recall Z-0583-2026— DERMASENSOR INC

Name: FDA recall Z-0583-2026
Creator: U.S. Food and Drug Administration
Published: 2025-10-13

Class II · Ongoing

Class II FDA medical device recall by DERMASENSOR INC, initiated 2025-10-13. FDA's recall record names no specific 510(k) clearance for this event. 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..

Recalling firm: DERMASENSOR INC
Classification: Class II
Status: Ongoing
Initiated: 2025-10-13
Firm location: Miami, FL, United States

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

Reason for recall

Potential for device to not meet specifications resulting in incorrect results or delay of referral for patients.

Data sourced from openFDA. This site is unofficial and independent of the FDA.