Z-0583-2026 Class II Ongoing
FDA device recall Z-0583-2026 was initiated by DERMASENSOR INC on October 13, 2025 and is designated Class II. Reason for recall: Potential for device to not meet specifications resulting in incorrect results or delay of referral for patients. The recall status is ongoing. Affected quantity: 343 (9 units affected).
Recall Details
- Product Type
- Devices
- Report Date
- December 3, 2025
- Initiation Date
- October 13, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 343 (9 units affected)
Product Description
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.
Distribution Pattern
US distribution to MD, FL, AZ, MS, PA, NY, CT, CA.
Code Information
Lot Code: Model No 10101; UDI-DI 085001778610101A9; Serial Number 1010120241230196E4E, 1010120241240151FD5, 101012024130014EF69, 101012024125014F595, 10101202413001F7C66, 1010120242400172717, 101012024325014CE26, 10101202433101D295C, 101012025093012EE03.