CLASS II Device recall · Reported 19 Dec 2012 · FDA Enforcement Report
Baby Quasar (Lab-001-D, BQ101) and Baby Quasar Pink recalled
Quasar Bio-Tech is recalling Baby Quasar (Lab-001-D, BQ101) and Baby Quasar Pink (Lab-046-A BQ101-P) are infrared LED, distributed nationwide in the US. The recall was initiated on 25 Oct 2012 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0517-2013
- FDA event ID
- 63530
- Recalling firm
- Quasar Bio-Tech, Sarasota, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Oct 2012
- FDA classified
- 12 Dec 2012
- Reported
- 19 Dec 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Temperature Abuse
- Device type
- Other Medical Devices
Timeline
| 25 Oct 2012 | Recall initiated by company | |
| 12 Dec 2012 | Classified by FDA | +48 days |
| 19 Dec 2012 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Quasar Bio-Tech is recalling their Baby Quasar, Baby Quasar Pink, Quasar Power Pack, and Quasar MD because the device is unapproved.
Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.
Product as listed by the FDA
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 quality components and durable aluminum. Five Year Warranty The product emits energy in the near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature. This device may be used to provide temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm. This device may temporarily increase local blood circulation, and may be used to promote relaxation of the muscle tissue.
Where it was distributed
Worldwide distribution: USA (nationwide) including states of: AZ, CA, CO, FL, GA, HI, ID, IL, KS, MD, MI, MN, MO, NC, NJ, NY, NV, OH, OR, TN, TX, UT, VA, and WA; and countries of: Aruba, Canada, Cayman Islands, China, Estonia, Ireland, Malaysia, New Zealand, Singapore, Sweden, Taiwan, and United Kingdom.
Nationwide ArizonaCaliforniaColoradoFloridaGeorgiaHawaiiIdahoIllinoisKansasMarylandMichiganMinnesotaMissouriNorth CarolinaNew JerseyNevadaNew YorkOhioOregonTennessee
Questions about this recall
Why was it recalled?
Quasar Bio-Tech is recalling their Baby Quasar, Baby Quasar Pink, Quasar Power Pack, and Quasar MD because the device is unapproved.
Which lots are affected?
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, UPC 837654072172, Batch # 11927, 11945, 11989, 11990 12017,12073.
Where was it sold?
Worldwide distribution: USA (nationwide) including states of: AZ, CA, CO, FL, GA, HI, ID, IL, KS, MD, MI, MN, MO, NC, NJ, NY, NV, OH, OR, TN, TX, UT, VA, and WA; and countries of: Aruba, Canada, Cayman Islands, China, Estonia, Ireland, Malaysia, New Zealand, Singapore, Sweden, Taiwan, and United Kingdom.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 63530This product is part of a recall event; the main page for the event is Quasar Power Pack contains a Baby Quasar and a Baby Blue recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Quasar Power Pack contains a Baby Quasar and a Baby Blue recalled | Quasar Bio-Tech | Other | Nationwide | |
| CLASS II | Quasar MD is an infrared LED lamp that is labeled in part recalled | Quasar Bio-Tech | Temperature Abuse | Nationwide |
More recalls from Quasar Bio-Tech
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Baby Quasar Plus, Light Therapy System, packaging recalled | Quasar Bio-Tech | Packaging Defects | Nationwide |
| Device | CLASS II | Quasar MD Plus, Light Therapy System, packaging, sleeve recalled | Quasar Bio-Tech | Packaging Defects | Nationwide |
| Device | CLASS II | Pure Rayz, Light Therapy System, packaging, sleeve and user manual recalled | Quasar Bio-Tech | Packaging Defects | Nationwide |
| Device | CLASS II | Quasar MD is an infrared LED lamp that is labeled in part recalled | Quasar Bio-Tech | Temperature Abuse | Nationwide |
| Device | CLASS II | Quasar Power Pack contains a Baby Quasar and a Baby Blue recalled | Quasar Bio-Tech | Other | Nationwide |
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