FDA Device recall Z-0819-2018
Ultra Renew
- FDA Device
- Class II
- terminated
- Published 2018-03-07
On 2018-03-07 the FDA classified a Class II recall of Ultra Renew by Accord Media, citing distribution of medical devices with unapproved green LED light used to treat hyperpigmentation.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0819-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-12-04 |
| Published | 2018-03-07 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Accord Media |
| Distribution | US |
Product
Ultra Renew
Reason
Distribution of medical devices with unapproved green LED light used to treat hyperpigmentation
Identifiers
| code_info | none |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0819-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.