Class II — DERMASENSOR INC
| Recalling firm | DermaSensor Inc |
|---|---|
| Registered facility | DERMASENSOR INC (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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 |
| Quantity | 343 (9 units affected) |
| Distribution | US distribution to MD, FL, AZ, MS, PA, NY, CT, CA. |
| Initiated | 2025-10-13 |
| Classified | 2025-11-21 |
| Recall number | Z-0583-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — DERMASENSOR INC (Z-0583-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97780/
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