DermaSensor — Class II medical device recall Z-0583-2026
Ongoing recall by DERMASENSOR INC, reported 2025-12-03, distributed in AZ, CA, CT, FL, MD, MS, NY, PA. Potential for device to not meet specifications resulting in incorrect results or delay of referral for patien
| Recall number | Z-0583-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | DERMASENSOR INC, Miami, FL, United States |
| Recall initiated | 2025-10-13 |
| Classified | 2025-11-21 |
| Reported by FDA | 2025-12-03 |
| Distributed | AZ, CA, CT, FL, MD, MS, NY, PA |
| Serial numbers | 1010120241230196E4E, 1010120241240151FD5, 101012024125014F595, 101012024130014EF69, 10101202413001F7C66, 1010120242400172717, 101012024325014CE26, 10101202433101D295C, 101012025093012EE03 |
| Model numbers | 10101 |
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 for recall
Potential for device to not meet specifications resulting in incorrect results or delay of referral for patients.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0583-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.