FDA (Devices) recall action 79262
The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.
Distribution of medical devices with unapproved green LED light used to treat hyperpigmentation
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Accord Media, LLC is recalling 1,040 units of the Ultra Renew Plus medical device because it uses an unapproved green LED light to treat hyperpigmentation.
Accord Media, LLC is recalling 30 units of the Truth Renew device because it uses an unapproved green LED light to treat hyperpigmentation.
Accord Media is recalling 67 units of the Truth Renew Plus device because it uses an unapproved green LED light to treat hyperpigmentation.
Accord Media, LLC is recalling 524 Ultra Renew devices distributed nationwide because they use an unapproved green LED light to treat hyperpigmentation.