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DERMASENSOR INC recalls DermaSensor. Model/Catalog Number: 10101. Software Version: 3.0.2. Software-aided adjunctive diagnostic device for us
Recalled December 3, 2025 · FDA recall Z-0583-2026 · DERMASENSOR
Hazard
Potential for device to not meet specifications resulting in incorrect results or delay of referral for patients. · FDA Class II
Units
343 (9 units affected)
Sold at
US distribution to MD, FL, AZ, MS, PA, NY, CT, CA.
Description
Potential for device to not meet specifications resulting in incorrect results or delay of referral for patients.
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
Manufacturer(s)
DERMASENSOR INC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →