CLASS II ONGOING Device recall · Reported 3 Dec 2025 · FDA Enforcement Report
DermaSensor. Model/Catalog Number: 10101. Software Version recalled
Dermasensor is recalling DermaSensor. Model/Catalog Number: 10101. Software Version: 3.0.2., distributed in 8 states. The recall was initiated on 13 Oct 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0583-2026
- FDA event ID
- 97780
- Recalling firm
- Dermasensor, Miami, FL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 13 Oct 2025
- FDA classified
- 21 Nov 2025
- Reported
- 3 Dec 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Device Malfunction
- Device type
- Test Kits & Diagnostics
Timeline
| 13 Oct 2025 | Recall initiated by company | |
| 21 Nov 2025 | Classified by FDA | +39 days |
| 3 Dec 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for device to not meet specifications resulting in incorrect results or delay of referral for patients.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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
Where it was distributed
US distribution to MD, FL, AZ, MS, PA, NY, CT, CA.
ArizonaCaliforniaConnecticutFloridaMarylandMississippiNew YorkPennsylvania
Questions about this recall
Is DermaSensor. Model/Catalog Number: 10101. Software Version: 3.0.2. recalled?
Yes. Dermasensor recalled DermaSensor. Model/Catalog Number: 10101. Software Version: 3.0.2. on 13 Oct 2025. The recall is Class II and its status is Ongoing. Recall number Z-0583-2026.
Why was it recalled?
Potential for device to not meet specifications resulting in incorrect results or delay of referral for patients.
Which lots are affected?
Lot Code: Model No 10101; UDI-DI 085001778610101A9; Serial Number 1010120241230196E4E, 1010120241240151FD5, 101012024130014EF69, 101012024125014F595, 10101202413001F7C66, 1010120242400172717, 101012024325014CE26, 10101202433101D295C, 101012025093012EE03.
Where was it sold?
US distribution to MD, FL, AZ, MS, PA, NY, CT, CA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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