Recall archive / FDA device enforcement
DermaSensor. Model/Catalog Number: 10101. Software Version: 3.0.2. Software-aided adjunctive diagnostic device for us... — FDA record Z-0583-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Oct 13, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class II
- Recalling firm
- DERMASENSOR INC
- Quantity
- 343 (9 units affected)
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0583-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot Code: Model No 10101; UDI-DI 085001778610101A9; Serial Number 1010120241230196E4E, 1010120241240151FD5, 101012024130014EF69, 101012024125014F595, 10101202413001F7C66, 1010120242400172717, 101012024325014CE26, 10101202433101D295C, 101012025093012EE03. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US distribution to MD, FL, AZ, MS, PA, NY, CT, CA.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Dec 3, 2025
- Recall initiation date
- Oct 13, 2025
- Center classification date
- Nov 21, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.