FDA Recalls Ultraslim Devices for Marketing Without Clearance
Advanced Photonic Systems is recalling 235 Ultraslim devices because they were marketed without FDA clearance or approval.
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, but the source text identifies the hazard as 'Marketing without marketing clearance or approval' rather than a physical defect or reported injury. This aligns with the rubric for moderate severity involving regulatory or labeling issues without reported harm.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for 235 Ultraslim devices manufactured by Advanced Photonic Systems, LLC. The recall covers models BR-144, BRS-144, and BRC-144, as well as products sold under various brand names including UltraSlim, Luxurian, BioSlim Lipo, Cellulize, Slim 'n Trim, UltraRed, UltraBlue, Slim-PRO, Dazzle Light, UltraSlim Cold Light, SlenderRay, and U-Slim It.
The reason for the recall is that the devices were marketed without the required FDA marketing clearance or approval. The company claims the program combines detoxification, red light exposure, hydration, full body vibration, massage, Niacin, Milk Thistle, and compression garments, but the lack of regulatory clearance is the primary issue cited by the agency.
The affected units were distributed worldwide, including in the United States (AL, AZ, CA, CO, FL, GA, ID, IL, IN, LA, MA, MD, MI, MN, MO, NV, NJ, NY, NC, OH, PA, TX, UT, and VA) and internationally to Canada, France, and Switzerland. Consumers who purchased these devices should stop using them and contact Advanced Photonic Systems, LLC for further instructions.
The recalled product
- Product
- Ultraslim. These include all products labeled as UltraSlim, Luxurian, BioSlim Lipo, Cellulize, Slim 'n Trim, UltraRed, UltraBlue, Slim-PRO, Dazzle Light, UltraSlim Cold Light, SlenderRay, and U-Slim It, as well as those products with private labelling branding. Company claims th
- Manufacturer
- Advanced Photonic Systems, LLC
- Affected units
- 235
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 (2)
- Models BR-144
- BRS-144 and BRC-144
Distribution
Part of a larger recall action
This product is one of 3 recalled by Advanced Photonic Systems, 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 3 products in this recall →Related recalls
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