Reported Dec 3, 2025 · Ongoing
DermaSensor. Model/Catalog Number: 10101. Software Version: 3.0.2. Software-aided adjunctive diagnostic device for use…
Dermasensor Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: DERMASENSOR INC · 801 Brickell Ave Ste 1610 · Miami, FL · 33131-4901
Is this the product you have?
- DermaSensor
- Model/Catalog Number10101
- Software Version3.0.2. Software-aided adjunctive diagnostic device for use by physicians on lesions suspicious for skin cancer
- Lot codes and dates
- Lot Code
Model No 10101UDI-DI 085001778610101A9Serial Number 1010120241230196E4E1010120241240151FD5101012024130014EF69101012024125014F59510101202413001F7C661010120242400172717101012024325014CE2610101202433101D295C101012025093012EE03
- Lot Code
- Amount recalled
- 343 (9 units affected)
Where it was sold
Why it was recalled
Potential for device to not meet specifications resulting in incorrect results or delay of referral for patients.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Dermasensor Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.