FDA Medical Device Recalls (openFDA)
Accord Media, LLC: Truth Renew
- Recall number
- Z-0820-2018
- Recalling firm
- Accord Media, LLC
- Product
- Truth Renew
- Status
- Terminated
- Initiated
- 2017-12-04
- Posted
- not on file
- Terminated
- 2020-05-28
- Reason
- Distribution of medical devices with unapproved green LED light used to treat hyperpigmentation
- Root cause
- Device Design
- Action
- On December 4, 2017, Accord Media distributed Urgent Medical Device Field Action notices and Response Forms to customers via courier service. Customers were instructed to inspect stock and identify affected product whereby the would apply a label to the product which reads "DO NOT USE GREEN LIGHT FUNCTIONALITY - NOT FDA CLEARED FOR USE". Customers are encouraged to complete and return the response form via email to: customerservice@truthinaging.com.
- Quantity
- 30 units
- Distribution
- US Nationwide
- Lot, serial or model codes
- none
- 510(k) numbers
- ["K132833"]
- PMA numbers
- not on file
- Product code
- OLP
- Firm FEI
- 3011053331
- Firm city
- New York
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28