Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

DermaSensor. Model/Catalog Number: 10101. Software Version: 3.0.2. Software-aided adjunctive diagnostic Recalled by DERMASENSOR INC Due to Potential for device to not meet specifications resulting...

Date: October 13, 2025
Company: DERMASENSOR INC
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact DERMASENSOR INC directly.

Affected Products

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

Quantity: 343 (9 units affected)

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed to 8 states: AZ, CA, CT, FL, MD, MS, NY, PA

Affected (8 states)Not affected

About DERMASENSOR INC

DERMASENSOR INC has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report