[pending] DermaSensor. Model/Catalog Number: 10101. Software Version: 3.0.2. Software-aided adjunctive diag
Pending LLM rewrite. Source: FDA_DEVICE Z-0583-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Potential for device to not meet specifications resulting in incorrect results or delay of referral for patients.
The recalled product
- 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
- Manufacturer
- DERMASENSOR INC
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- Lot Code: Model No 10101
- UDI-DI 085001778610101A9
- Serial Number 1010120241230196E4E
- 1010120241240151FD5
- 101012024130014EF69
- 101012024125014F595
- 10101202413001F7C66
- 1010120242400172717
- 101012024325014CE26
- 10101202433101D295C
- 101012025093012EE03.
Distribution
Distributed in 8 states:
- AZ
- CA
- CT
- FL
- MD
- MS
- NY
- PA
Related recalls
Same category
- ModerateOneLIF Interbody Cage Inserter Attachment Failure Recall
FDA (Devices) · 2026-05-27
- HighOncology Kit With Extension Sets May Leak During Infusion Therapy
FDA (Devices) · 2026-05-27
- ModerateMedtronic DLP Retrograde Cannula Model 94965 Sterile Barrier Breach
FDA (Devices) · 2026-05-27
- SevereMedtronic DLP Retrograde Cannula Recalls for Sterile Barrier Breach Risk
FDA (Devices) · 2026-05-27
- HighMedtronic GUNDRY Retrograde Cannula Model 94113T sterile barrier recall
FDA (Devices) · 2026-05-27