DERMASENSOR INC: Medical Device Recall in 2025 - (Recall #: Z-0583-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: October 13, 2025

Date Posted: December 3, 2025

Recall Number: Z-0583-2026

Event ID: 97780

Reason for Recall:

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

Status: Ongoing

Product Quantity: 343 (9 units affected)

Code Information:

Lot Code: Model No 10101; UDI-DI 085001778610101A9; Serial Number 1010120241230196E4E, 1010120241240151FD5, 101012024130014EF69, 101012024125014F595, 10101202413001F7C66, 1010120242400172717, 101012024325014CE26, 10101202433101D295C, 101012025093012EE03.

Distribution Pattern:

US distribution to MD, FL, AZ, MS, PA, NY, CT, CA.

Voluntary or Mandated:

Voluntary: Firm initiated