Data Foundry

Medical device recalls 2012

Baby Quasar — Class II medical device recall Z-0517-2013

Terminated recall by Quasar Bio-Tech, Inc. dba Silver Bay LLC, reported 2012-12-19, distributed nationwide. Quasar Bio-Tech is recalling their Baby Quasar, Baby Quasar Pink, Quasar Power Pack, and Quasar MD because the

Recall numberZ-0517-2013
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmQuasar Bio-Tech, Inc. dba Silver Bay LLC, Sarasota, FL, United States
Recall initiated2012-10-25
Classified2012-12-12
Reported by FDA2012-12-19
Terminated2013-05-21
DistributedNationwide (US)
Countries outside the USAW, CA, CN, EE, GB, IE, KY, MY, NZ, SE, SG, TW
Quantity7,734 devices
Reason classesunapproved product
UPC / GTIN / UDI-DI00837654072172
Lot numbers11253, 11523, 11658, 11927, 11945, 11989, 11990, 12017, 12073, 13009, 13177, 13186, 13243, 13270, 13306, 13327, 13342, 13459, 13528, 13529, 13635, 13730, 13767, 2382
Model numbersBQ-101, BQ-101-P

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 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.

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0517-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.