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Terminated

Ultra Renew

FDA Recall Z-0819-2018 · Posted None

Recalling FirmAccord Media, LLC
Recall StatusTerminated
Product CodeOLP
Date Initiated2017-12-04
Date Terminated2020-05-28
Product Quantity524 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.

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