Accord Media Recalls Ultra Renew Devices for Unapproved LED Light
Accord Media, LLC is recalling 524 Ultra Renew devices distributed nationwide because they use an unapproved green LED light to treat hyperpigmentation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with an unapproved component (green LED light) used for treatment, which fits the rubric criterion for 'risk-of-harm products where injury has not yet been reported.' No specific FDA Class I/II designation or injury reports were provided in the source text to justify a higher score.
Plain-English summary
Accord Media, LLC is recalling 524 units of the Ultra Renew medical device. The devices were distributed nationwide in the United States.
The recall was initiated because the devices use an unapproved green LED light intended to treat hyperpigmentation. The source text does not specify any reported illnesses, injuries, or deaths associated with the use of these devices.
Consumers who possess these devices should stop using them and contact Accord Media, LLC for further instructions or a refund, as directed by the recall notice.
The recalled product
- Product
- Ultra Renew
- Manufacturer
- Accord Media, LLC
- Hazard
- Affected units
- 524
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 Ultra Renew Plus LED Light Device
FDA (Devices) · 2018-03-07
- 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
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