FDA Medical devices recall ·
DermaSensor recall
- Recall number
- Z-0583-2026
- Date
- (initiated October 13, 2025)
- Company / brand
- Dermasensor Inc
801 Brickell Ave Ste 1610, Miami, FL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 343 (9 units affected)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Potential for device to not meet specifications resulting in incorrect results or delay of referral for patients.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot Code: Model No 10101; UDI-DI 085001778610101A9; Serial Number 1010120241230196E4E, 1010120241240151FD5, 101012024130014EF69, 101012024125014F595, 10101202413001F7C66, 1010120242400172717, 101012024325014CE26, 10101202433101D295C, 101012025093012EE03.
Distribution
US distribution to MD, FL, AZ, MS, PA, NY, CT, CA.
States: Arizona California Connecticut Florida Maryland Mississippi New York Pennsylvania
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0583-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.