FDA Device recall Z-0583-2026
DermaSensor
- FDA Device
- Class II
- ongoing
- Published 2025-12-03
On 2025-12-03 the FDA classified a Class II recall of DermaSensor by Dermasensor, citing potential for device to not meet specifications resulting in incorrect results or delay of referral for patients.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0583-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-10-13 |
| Published | 2025-12-03 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Dermasensor |
| Distribution | AZ, CA, CT, FL, MD, MS, NY, PA |
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.
Identifiers
| code_info | Lot Code: Model No 10101; UDI-DI 085001778610101A9; Serial Number 1010120241230196E4E, 1010120241240151FD5, 10101202413…Lot Code: Model No 10101; UDI-DI 085001778610101A9; Serial Number 1010120241230196E4E, 1010120241240151FD5, 101012024130014EF69, 101012024125014F595, 10101202413001F7C66, 1010120242400172717, 101012024325014CE26, 10101202433101D295C, 101012025093012EE03. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0583-2026%22
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