The Recall Desk
ModerateFDA (Devices)·Z-0820-2018·Announced 2018-03-07

Accord Media Recalls Truth Renew Device for Unapproved LED Light

Accord Media, LLC is recalling 30 units of the Truth Renew device because it uses an unapproved green LED light to treat hyperpigmentation.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use may cause temporary or medically reversible health consequences. The source does not report specific injuries or illnesses, aligning with a moderate severity rating for a regulatory compliance issue involving an unapproved feature.

Plain-English summary

Accord Media, LLC is recalling 30 units of the Truth Renew medical device. The recall is due to the distribution of the device with an unapproved green LED light used to treat hyperpigmentation.

The affected units were distributed nationwide in the United States. The source text does not specify a particular lot number or date of distribution.

Consumers who possess this device should stop using it and contact the recalling firm, Accord Media, LLC, for further instructions.

The recalled product

Product
Truth Renew
Manufacturer
Accord Media, LLC
Affected units
30

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • none

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Accord Media, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Same manufacturer · Accord Media, LLC

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