Ultra Renew Plus — Class II medical device recall Z-0821-2018
Terminated recall by Accord Media, LLC, reported 2018-03-07, distributed nationwide. Distribution of medical devices with unapproved green LED light used to treat hyperpigmentation
| Recall number | Z-0821-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Accord Media, LLC, New York, NY, United States |
| Recall initiated | 2017-12-04 |
| Classified | 2018-03-01 |
| Reported by FDA | 2018-03-07 |
| Terminated | 2020-05-28 |
| Distributed | Nationwide (US) |
| Quantity | 1,040 units |
| Reason classes | unapproved product |
Product
Ultra Renew Plus
Reason for recall
Distribution of medical devices with unapproved green LED light used to treat hyperpigmentation
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-0821-2018. 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.