Quick Facts at a Glance
- Recall Date
- October 13, 2025
- Hazard Level
- HIGH
- Brand
- DERMASENSOR
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 8 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- DERMASENSOR
- Product type
- Software-aided diagnostic device
- Model numbers
- 10101, Lot Code: Model No 10101, UDI-DI 085001778610101A9, Serial Numbers 1010120241230196E4E, 1010120241240151FD5, 101012024130014EF69, 101012024125014F595, 10101202413001F7C66 +4 more
- Sold at
- Unknown
- Where affected
- MD, FL, AZ, MS, PA, NY, CT, CA
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
October 13, 2025
Reported by FDA DEVICE
December 3, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Potential for device to not meet specifications resulting in incorrect results or delay of referral for patients.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact DERMASENSOR INC or your healthcare provider for instructions. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
About This Product
The DermaSensor 10101 is a software-aided diagnostic device used by physicians to assist in evaluating lesions suspicious for skin cancer.
Why This Is Dangerous
If the device does not meet specifications, it can produce incorrect results or delay referrals, potentially affecting patient outcomes.
Industry Context
This recall is not described as part of a broader industry pattern in the provided information.
Real-World Impact
Clinicians may need to re-evaluate prior assessments and consider independent testing or follow-up with alternative diagnostic methods.
Practical Guidance
How to identify if yours is affected
- Verify model number 10101 on the device label or documentation.
- Check UDI-DI 085001778610101A9.
- Review serial numbers listed in the recall notice.
Where to find product info
Identifiers appear on device labeling, user manual, or packaging. The recall page provides official details.
What timeline to expect
Not specified in the recall. Manufacturers typically outline next steps and timelines in recall communications.
If the manufacturer is unresponsive
- Document all contact attempts with Dermasensor Inc.
- Escalate to the FDA recall program if the manufacturer is unresponsive.
- Consider consulting hospital compliance or patient safety offices for guidance.
How to prevent similar issues
- Verify device integrity before use in clinical settings.
- Keep all recall communications and device documentation organized.
- Seek FDA-cleared alternative devices if replacement is needed.
Documentation advice
Maintain records of recall notices, communications with the manufacturer, and any corrective actions taken for patients and facilities.
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Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 343 total units recalled; 9 affected
- Distributed to medical practices across eight states
- Software version 3.0.2 tied to the affected lot
- UDI-DI 085001778610101A9 included
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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