Z-0822-2018Class II

Truth Renew Plus

Name: Z-0822-2018 Truth Renew Plus
Creator: Accord Media, LLC
Published: 2017-12-04
License: https://open.fda.gov/license/

Accord Media / initiated 2017-12-04 / Terminated / root cause: design

FDA source

Accord Media, LLC began a recall of Truth Renew Plus on 2017-12-04. FDA classified it as Class II and gives the reason as "Distribution of medical devices with unapproved green LED light used to treat hyperpigmentation". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0822-2018
Classification: Class II
Status: Terminated
Initiated: 2017-12-04
Posted: 2018-03-01
Terminated: 2020-05-28
Recalling firm: Accord Media
Product: Truth Renew Plus
Product code: OLP Over-The-Counter Powered Light Based Laser For Acne
Reason for recall: Distribution of medical devices with unapproved green LED light used to treat hyperpigmentation
Root cause tag: design
FDA 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: [email protected].
Quantity in commerce: 67 units
Distribution: US Nationwide
Product codes and lots: none

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0822-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0819-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-03-01
Z-0820-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-03-01
Z-0821-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-03-01
Z-0822-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-03-01

Product code OLP

K132833Class IIUltra Renew PlusAccord Media / cleared 2014-06-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)