Quasar Bio-Tech Recalls Unapproved Baby Quasar Infrared LED Lamps
Quasar Bio-Tech is recalling Baby Quasar and Baby Quasar Pink infrared LED lamps because the devices are unapproved by the FDA.
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 health consequences. The source text does not report any specific injuries, illnesses, or deaths, and the primary issue is regulatory non-compliance (unapproved device) rather than a specific physical defect causing harm.
Plain-English summary
Quasar Bio-Tech, Inc. dba Silver Bay LLC is recalling the Baby Quasar (Model BQ-101) and Baby Quasar Pink (Model BQ-101-P) infrared LED lamps. The recall is being conducted because the devices are unapproved by the U.S. Food and Drug Administration.
The affected products are skin rejuvenating systems that emit energy in the near-infrared spectrum to provide topical heating. The recall covers 7,734 devices distributed worldwide, including nationwide distribution in the United States and in various international countries such as Canada, the United Kingdom, and China.
Consumers who possess these devices should stop using them and contact Quasar Bio-Tech for further instructions regarding the recall.
The recalled product
- Product
- Baby Quasar (LAB-001-D, BQ101) and Baby Quasar Pink (LAB-046-A BQ101-P) are infrared LED lamps that are labeled in part: "***BABY QUASAR***FOR YOUTHFUL RADIANT SKIN***Skin Rejuvenating System with Sequepulse***Manufactured by: Silver Bay, LLC; Made in the USA, with highest…
- Manufacturer
- Quasar Bio-Tech, Inc. dba Silver Bay LLC
- Hazard
- Affected units
- 7,734
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 (20)
- Baby Quasar- Model BQ-101
- UPC Code 6 89076290272
- Batch # 11253
- 11523
- 11658
- 2382
- 13009
- 13177
- 13186
- 13243
- 13270
- 13306
- 13327
- 13342
- 13459
- 13528
- 13529
- 13635
- 13730
- 13767. Baby Quasar Pink- Model BQ-101-P
Distribution
Part of a larger recall action
This product is one of 3 recalled by Quasar Bio-Tech, Inc. dba Silver Bay 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
Same manufacturer · Quasar Bio-Tech, Inc. dba Silver Bay LLC
See all →- ModerateQuasar Bio-Tech Recalls Unapproved LED Skin Treatment Devices
FDA (Devices) · 2012-12-19
- ModerateQuasar Bio-Tech Recalls Unapproved Infrared LED Lamps and Accessories
FDA (Devices) · 2012-12-19
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