Quasar Bio-Tech Recalls Baby Quasar Plus Light Therapy System
Quasar Bio-Tech is recalling the Baby Quasar Plus Light Therapy System because it lacks FDA clearance for specific collagen and elastin claims.
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 and involves a labeling/clearance issue regarding unapproved claims, which aligns with the rubric for moderate severity involving minor labeling errors or voluntary precautionary recalls without reported injuries.
Plain-English summary
Quasar Bio-Tech, Inc. is recalling the Baby Quasar Plus, Light Therapy System, including its packaging, box, sleeve, and user manual. The recall involves 6,783 units of the handheld wrinkles reduction device, identified by Product Number DPA-023 and UPC Code 0 91037 46144 5.
The recall was initiated because Quasar did not receive FDA clearance for the claims of collagen and elastin production stated on the packaging and in the user manuals. The agency classification for this recall is Class II.
The affected products were distributed nationwide to California, Florida, Georgia, Hawaii, Illinois, Louisiana, Maryland, Nebraska, New York, Ohio, Texas, Virginia, Washington, and Wisconsin. Additionally, the products were distributed worldwide to Australia, China, the Netherlands, and the United Kingdom. Consumers should stop using the product and contact the recalling firm for instructions.
The recalled product
- Product
- Baby Quasar Plus, Light Therapy System, packaging, box, sleeve and user manual. Handheld Wrinkles Reduction Device.
- Manufacturer
- Quasar Bio-Tech, Inc.
- Category
- Medical Device — Light Therapy
- Hazard
- Affected units
- 6,783
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)
- Product Number DPA-023. UPC Code 0 91037 46144 5
Distribution
Part of a larger recall action
This product is one of 3 recalled by Quasar Bio-Tech, Inc. 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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