MelaFind Device — Class II medical device recall Z-1636-2015
Terminated recall by MELA Sciences, Inc., reported 2015-05-27, distributed in AL, CA, CO, CT, FL, HI, IL, MA…. The probability and histogram data within the Melafind's device displayed user interface lacks approval (not i
| Recall number | Z-1636-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | MELA Sciences, Inc., Irvington, NY, United States |
| Recall initiated | 2015-04-02 |
| Classified | 2015-05-20 |
| Reported by FDA | 2015-05-27 |
| Terminated | 2016-05-04 |
| Distributed | AL, CA, CO, CT, FL, HI, IL, MA, MD, MI, NH, NJ, NY, OH, PA, RI, SC, TN, TX, VA, WA |
| Quantity | 65 units |
| Model numbers | 100US |
Product
MelaFind Device, Model MF 100 US, optical diagnostic device for melanoma detection.
Reason for recall
The probability and histogram data within the Melafind's device displayed user interface lacks approval (not included in the PMA supplement).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1636-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.