Accord Media Recalls Ultra Renew Plus LED Light Device
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.
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 temporary or medically reversible adverse health consequence. The source text does not report any specific injuries, illnesses, or hospitalizations, and the hazard is primarily regulatory (unapproved light source) rather than a high-risk pathogen or structural defect.
Plain-English summary
Accord Media, LLC is recalling 1,040 units of the Ultra Renew Plus 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 date range for distribution or identify specific lot numbers.
Consumers who possess this device should stop using it and contact Accord Media, LLC for further instructions on how to return or dispose of the product.
The recalled product
- Product
- Ultra Renew Plus
- Manufacturer
- Accord Media, LLC
- Category
- Medical Device — Light Therapy
- Hazard
- Affected units
- 1,040
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 →Related recalls
Same manufacturer · Accord Media, LLC
See all →- ModerateAccord Media Recalls Truth Renew Device for Unapproved LED Light
FDA (Devices) · 2018-03-07
- ModerateAccord Media Recalls Truth Renew Plus LED Light Device
FDA (Devices) · 2018-03-07
- HighAccord Media Recalls Ultra Renew Devices for Unapproved LED Light
FDA (Devices) · 2018-03-07
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