# FDA recall Z-0583-2026

> **DERMASENSOR INC** · Class II · device recall initiated 2025-10-13.

## 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

## Reason for recall

Potential for device to not meet specifications resulting in incorrect results or delay of referral for patients.

## Distribution

US distribution to MD, FL, AZ, MS, PA, NY, CT, CA.

## Key facts

- **Recall number:** Z-0583-2026
- **Recalling firm:** DERMASENSOR INC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-10-13
- **Report date:** 2025-12-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Miami, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0583-2026

## Citation

> AI Analytics. FDA recall Z-0583-2026. Retrieved 2026-07-25 from https://api.ai-analytics.org/recall/Z-0583-2026. Source: US FDA. Licensed CC0.

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