The Recall Desk
ModerateFDA (Devices)·Z-2183-2012·Announced 2012-08-22

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.

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 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.
Affected units
598

Distribution

Distributed nationwide across the United States.

Same manufacturer · JK Products & Services, Inc

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