Truth Renew
FDA Recall Z-0820-2018 · Posted None
Recalling FirmAccord Media, LLC
Recall StatusTerminated
Product CodeOLP
Date Initiated2017-12-04
Date Terminated2020-05-28
Product Quantity30 units
Reason for Recall
Distribution of medical devices with unapproved green LED light used to treat hyperpigmentation
Firm 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].
Root Cause
Device Design
Distribution Pattern
US Nationwide
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.