Beauty Angel Device Recalled for Lack of FDA Clearance
JK Products & Services is recalling Beauty Angel devices because they were marketed without the required FDA 510(k) clearance.
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 2/5 (Moderate).
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 of the product may cause temporary or medically reversible adverse health consequences. The specific hazard is a regulatory compliance failure (lack of 510(k) clearance) rather than a reported physical injury or contamination.
Plain-English summary
JK Products & Services, Inc. is recalling 598 units of the BeautyAngel Health Fitness Natural Collagen Stimulation Anti Aging device. The product was distributed nationwide in the United States and in Canada. The recall affects all Beauty Angel models and serial numbers with part numbers 80000904301 and 8001110201.
The recall was initiated because the device was marketed without a 510(k) clearance from the U.S. Food and Drug Administration. A 510(k) is a premarket submission process used to provide the FDA with evidence that a device is at least as safe and effective as a legally marketed device.
Consumers who possess this device should stop using it and contact the recalling firm for instructions on how to return or dispose of the product.
The recalled product
- Product
- BeautyAngel Health Fitness Natural Collagen Stimulation Anti Aging For human use.
- Manufacturer
- JK Products & Services, Inc
- Affected units
- 598
Distribution
Distributed nationwide across the United States.
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