Events

Recall of Device Recall Ultra Renew

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Accord Media, LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    79262
  • Event Risk Class
    Class 2
  • Event Number
    Z-0819-2018
  • Event Initiated Date
    2017-12-04
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161783
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Over-the-counter powered light based laser for acne - Product Code OLP
  • Reason
    Distribution of medical devices with unapproved green led light used to treat hyperpigmentation.
  • 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.

Device

Device Recall Ultra Renew

Manufacturer

Accord Media, LLC
  • Manufacturer Address
    Accord Media, LLC, Apartment 16, 241 West 36th Street, New York NY 10018
  • Manufacturer Parent Company (2017)
    Accord Media Llc
  • Source
    USFDA